2020 Blog

Feeling Overwhelmed?

bjgabrielsen : October 29, 2020 11:00 pm : 2020, Encouragement

Jesus calms any storms. Photo: Shutterstock

I hope today finds you all doing well and healthy. But, as cancer survivors, we all have had days wherein we were feeling overwhelmed either with the disease itself or our anxieties. So for those days, I pass along this message I recently received from YouVersion entitled “You Are Not Alone.”

If you are unsure of your personal relationship with God through Jesus Christ, see the following.


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PyL Prostate Cancer Imaging Agent Submitted to FDA for Approval

bjgabrielsen : October 13, 2020 7:56 pm : 2020, Diagnostics, Genetics, Imaging

Lantheus Holdings has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval of PyL, an investigational imaging agent used to locate prostate cancer lesions. The new drug application (NDA) sent to the FDA includes a request for priority review, which if granted may shorten PyL’s regulatory review process from the usual 10 months to six. Lantheus expects the FDA’s decision on this filing in early December.

PyL, also known as 18F-DCFPyl, is a tracing agent used in positron emission tomography or PET scans to visualize prostate cancer lesions in different types of tissues. It does this by targeting the prostate-specific membrane antigen (PSMA), a protein commonly found on the surface of prostate cancer cells. Once bound to these cells, PyL emits a radioactive signal that can be seen in PET scans, signaling where these lesions are located.

The company’s NDA submission was supported by data from two clinical trials — OSPREY (NCT02981368) and CONDOR (NCT03739684) — that showed PyL can detect local and distant prostate cancer lesions that conventional imaging methods sometimes miss. Such detection makes tracking disease recurrence and spread more accurate, enabling doctors to adjust treatment plans appropriately.

In the Phase 2/3 OSPREY trial, PyL showed good sensitivity and specificity at identifying cancer lesions among 385 men, split into two groups. Group A included men with high-risk locally advanced prostate cancer, while group B involved men with metastatic or recurrent disease. Of note, in this context, sensitivity refers to PyL’s ability to identify true cancer sites, and specificity to its ability to distinguish cancer sites from non-cancer (healthy) sites.

Among men from group A, PyL had a specificity of 96-99%, a sensitivity of 31-42%, and a positive predictive value (PPV) of 78-91% at identifying cancer lesions in pelvic lymph nodes. The PPV is the proportion of patients with positive results who truly have the disease. In the group B participants, PyL had a sensitivity of 93-99% and a PPV of 81-88% at detecting metastatic cancer lesions, meaning those found farther away from the prostate. Metastatic cancer is disease that has spread to other parts of the body.

The participants tolerated PyL well and reported no serious undesirable side effects. The most frequent side effects observed included altered or unpleasant taste sensations and headaches.

The Phase 3, open-label CONDOR study evaluated PyL’s ability to safely and accurately detect prostate cancer lesions in 208 men with suspected disease relapse. All of the patients enrolled in the study had high levels of prostate-specific antigen (PSA), a biomarker of prostate cancer, but had negative or ambiguous imaging results. The study met its main goal, with PyL correctly locating cancer lesions in 85-87% of the patients. As a result of these findings, nearly 64% of participants saw changes in their treatment management plans.

Dr. Istvan Molnar, MD, chief medical officer of Lantheus, stated “we believe that the demonstrated strong diagnostic performance of PyL, will assist in treatment decisions and, ultimately, may improve patient outcomes,”

Much of the above appeared in the Oct. 6th, 2020 Prostate Cancer News Today, by Forest Ray.


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The Promise of Peace

bjgabrielsen : October 2, 2020 12:41 pm : 2020, Encouragement

Wooden Stave church built in the 12th century in western Norway

Philippians 4:6-7 states as follows: “Be anxious for nothing, but in everything by prayer and supplication (asking humbly and earnestly), with thanksgiving, let your requests be made known to God; and the peace of God, which surpasses all understanding, will guard your hearts and minds through Christ Jesus.”

Earlier this month, I needed to undergo a CT scan and a bone scan in order to identify and locate any sites of prostate cancer metastasis. Tests such as these always seem to be accompanied by apprehension and to some degree, anxiety. I also had to be alone for the entire day at Moffitt Cancer Center in Tampa as my wife and her support were not permitted to be there due to COVID-19. I sat alone with my thoughts and the oft-accompanying “what-ifs.” What if sites of metastatic cancer were revealed? How would they be treated? How would it all affect my life and life span? However, I also experienced periods of strong inner peace especially as my mind focused on the words of Philippians 4:6-7. I literally presented my thoughts, anxiety and requests to God who in turn promised that “the peace of God, which transcends all understanding, will guard your (my) heart and mind in Christ Jesus.” As if God wanted to punctuate this message with an exclamation point, I had briefly verbalized my trust in Jesus to the technician who performed one of the scans. Immediately, he responded enthusiastically that he also had put his faith in Jesus earlier in his life and the two of us formed a brotherly bond as the scanner passed over my body.

Are you, my reader, facing a similar situation with an unknown result and no apparent solution? Then, like a soothing salve to your anxious heart, the same promise of Philippians 4 is for you as well.

Unfortunately, anxiety does not come with an automatic “off” switch. One of the most complex human emotions, anxiety warns us that something could be wrong and may need attention. But anxiety may not inheritantly be a bad thing, especially if it drives us to prayer. Yet submission in prayer can often be the last thing we think to do.

Through a relationship with God through Jesus, we have access to the very throne room of heaven. God’s spirit intercedes for us there with “groaning too deep for words” (Romans 8:26). Even when we don’t know how to pray, we are not hindered. And remember, God would not invite us to bring our cares and requests before Him if He did not plan to act.

His promise is not that all our requests will be granted in the way we would hope or anticipate. But He promises the peace of Jesus Christ which will guard our hearts….and that is better by far! If you have never been introduced to a personal relationship with God through Jesus Christ, see the following link.

By the way, neither of my scans revealed any metastatic sites, for which I humbly but fervently give God the glory and thanks.

A portion of the above is an excerpt from the Sept. 2nd, 2020 devotional from Haven Ministries.


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ExoDx Urine Prostate Test to Evaluate Risk of Aggressive Prostate Cancer Prior to First Biopsy.

bjgabrielsen : September 15, 2020 8:32 pm : 2020, Diagnostics, Genetics, Imaging

The ExoDx Prostate Test is a non-invasive, non-digital rectal exam, urine test used as a risk assessment tool to provide risk probabilities for aggressive prostate cancer.

The technology relies on cancer-specific genomic biomarkers found in the urine. The test analyzes three cancer-specific biomarkers found in the urine associated with aggressive prostate cancer: ERG, PCA and SPDEF. It purposefully does not analyze prostate specific antigen (PSA). Patients below the cut-point of 15.6 are considered at low risk of having high-grade prostate cancer. Patients above the cut-point of 15.6 are considered to have higher risk of high-grade prostate cancer.

The test is intended for men over 50 with PSA’s from 2-10 ng/mL and considering an initial biopsy. The doctor and the patient should discuss the patients’ ExoDx Prostate score in a shared decision-making process including all relevant factors and make a decision as to whether or not to proceed with a prostate biopsy.

This urine-exosome, pre-biopsy risk stratification technology is now commercialized. See the following link.


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With Two New FDA Approvals, Prostate Cancer Treatment Enters the PARP Era.

bjgabrielsen : August 29, 2020 6:35 pm : 2020, Treatment Information

Two recent approvals by the Food and Drug Administration (FDA) have opened a new avenue of treatment for some men with prostate cancer: an expanded role for targeted therapies.

The approvals are for the drugs olaparib (Lynparza) and rucaparib (Rubraca). They cover the use of the drugs in men whose prostate cancer has spread, or metastasized, and whose disease has stopped responding to standard hormone treatments, often called castration-resistant disease. To receive either drug, men must also have specific genetic alterations that prevent their cells from repairing damage to their DNA.

Many treatments of metastatic prostate cancer are centered around therapies that block the ability of hormones to fuel the cancer’s growth and spread. But olaparib and rucaparib, which are taken as pills, work differently. They block the activity of a protein known as PARP, which helps cells mend specific types of damage to DNA. PARP inhibitors work in part by blocking the ability of PARP proteins to repair damaged DNA, which includes recruiting other DNA repair proteins.

Studies have shown that 20%–30% of men with metastatic prostate cancer have genetic alterations that impair cells’ DNA repair mechanisms. So, to now have two new approved therapies for these men, and in such rapid succession, “is good news for patients,” said Oliver Sartor, M.D., medical director of the Tulane Cancer Center and a prostate cancer expert. The past decade has seen a boom in new treatments for prostate cancer. But few of them are genomic targeted therapies, those intended to work on cells with specific genetic alterations, which are now commonly used to treat other types of cancer.

PARP: Prime Treatment Target for Prostate Cancer
Over the past decade, olaparib and rucaparib have become important treatments for women with ovarian and breast cancer, in whom genetic alterations that affect DNA repair processes are common. Among the most frequent such alterations are those in the BRCA1 and BRCA2 genes.

It’s no accident that researchers have identified people who have alterations in BRCA genes as ideal candidates for treatment with PARP inhibitors. BRCA proteins and some PARP proteins are both integral components of cells’ response to DNA damage. If that response is already dysfunctional because of BRCA1 or BRCA2 mutations, then researchers reasoned that blocking the activity of PARP proteins could further hamper any chance of repair—akin to punching a hole in a tire that already has a slow leak. If the cancer cells can’t fix the DNA damage, they will die.

Prostate cancer emerged as another strong candidate for PARP inhibitors after studies suggested that alterations in BRCA1 and BRCA2, as well as other genes involved in a cell’s ability to respond to DNA damage, may be present in approximately one-quarter of men with the disease. Other studies linked these genetic changes to an increased risk of prostate cancer, as well as more aggressive disease. Those findings, led to a series of clinical trials of PARP inhibitors in men with metastatic prostate cancer, laying the foundation for the new FDA approvals.

PROFOUND Trial: Most Benefit Seen in Men with BRCA2 Alterations
Olaparib’s approval, announced on May 19, was based on the results of a large clinical trial called PROFOUND. The trial enrolled men with mutations in DNA repair genes and divided them into two cohorts. Cohort A included men with alterations in the BRCA1, BRCA2, or ATM genes, each of which plays an important role in DNA repair. Cohort B included men who had alterations in a group of 12 other genes that have some involvement in repairing DNA.

All of the men in the trial had cancer that had worsened despite treatment with either abiraterone (Zytiga) or enzalutamide (Xtandi), which work in different ways to block hormones in prostate cancer cells. The 387 men in the trial were randomly assigned to either the treatment group, which received olaparib, or the control group, which received either abiraterone or enzalutamide (as selected by each patient’s oncologist).

In cohort A, men treated with olaparib lived more than twice as long without evidence of their cancer getting worse (as measured by standard imaging procedures) than men treated with abiraterone or enzalutamide: a median of 7.4 months versus 3.6 months. The treatment group in cohort A also lived longer overall, with olaparib improving survival by more than 4 months (19.1 months versus 14.7 months). In addition, men treated with olaparib were far more likely to see their tumors shrink (a tumor response) than men treated with one of the other two drugs (33% versus 2%).

Prostate cancer tends to spread to the bones, so reducing the size of those particular tumors can have a meaningful impact on patients, according to the trial’s lead investigator, Maha Hussain, M.D., of Northwestern Medicine. Metastases that are poorly controlled in the bone can be quite painful.

FDA’s approval covers the use of the drug in men with alterations in any of the DNA repair genes analyzed in the trial. But Dr. Sartor, who also was an investigator on the trial, noted that men with alterations in BRCA2 seemed to respond best to the treatment, experiencing the largest improvement in progression-free survival. And these men accounted for about one-third of trial participants. Men with ATM alterations, on the other hand, didn’t do any better than those in the control group.

FDA also simultaneously approved two tests, BRACAnalysis CDx and FoundationOne CDx, for identifying patients with metastatic castration-resistant prostate cancer who have the appropriate genetic alterations to receive olaparib.

TRITON2 Leads to Accelerated Approval for Rucaparib
FDA’s approval for rucaparib, announced on May 15, is slightly different than what was granted to olaparib.

To begin with, it was an accelerated approval. That means the approval was granted based on results from a clinical trial that strongly suggests rucaparib could be beneficial for patients—such as an improvement in progression-free survival—although that level of proof is not yet available. In addition, the approved use is only for men with mutations in BRCA1 or BRCA2 and only for cancer that has progressed despite earlier treatment with both a hormone-blocking treatment as well as chemotherapy.

The approval was based on the results of a 115-patient clinical trial, called TRITON2. Similar to the PROFOUND trial, TRITON2 enrolled men with alterations in a host of DNA repair genes, the largest group of which was those with BRCA2 mutations. All the men in the trial were treated with rucaparib.

According to data presented last year—and similar to what was seen in PROFOUND—men with BRCA2 alterations were most likely to respond to the PARP inhibitor. Of the 62 men with BRCA2 alterations, nearly 45% had a tumor response. And, in more than half of these men, the response lasted for at least 6 months.

Overall, Dr. Karzai said, it does appear that BRCA2 alterations “really do drive the benefit” of PARP inhibitors among men with metastatic prostate cancer. “I think we’re really seeing that in these trials.”

Making Treatment Choices: Olaparib or Rucaparib?
Often, when multiple drugs are approved for the same—or in this case, a very similar—use, the side effects associated with each drug can help doctors decide which therapy is best for each patient. Overall, Dr. Sartor explained, there aren’t notable differences in the types or severity of the side effects caused by olaparib and rucaparib.

And although most patients seem to handle the side effects caused by both drugs relatively well, he continued, they can cause substantial problems, including anemia, severe drops in white blood cell count, nausea, and vomiting. Dr. Karzai also pointed to the risk of myelodysplastic syndrome, a disorder that affects the formation of blood cells in the bone marrow and that has been seen in a very small percentage of patients treated with PARP inhibitors. “These drugs definitely require close monitoring [of patients],” Dr. Sartor said.

One potential advantage of rucaparib over olaparib could be the eventual availability of a blood test, called a liquid biopsy, that can identify men with BRCA1 or BRCA2 alterations (as well as other genetic alterations) who are candidates for the drug. This liquid biopsy, called FoundationOne Liquid CDx, is currently being evaluated by FDA and a decision on its approval is expected soon, according to a spokesperson for Foundation Medicine, which manufactures the test.

One reason that’s important, Dr. Karzai explained, also comes back to the fact that prostate cancer so often spreads to the bones. Because bone metastases are often hard and dense, she said, biopsies of these sites are “notorious for not having enough tissue to do standard genetic sequencing.” In addition to tissue quantity, there are also issues with the type of tissue that comes from the biopsy and its quality. “There a lot of variables that can make it difficult,” she added.

The PROFOUND trial provides a case in point: In nearly one-third of tissue samples collected from more than 4,000 men screened as possible participants for the trial, the genetic test used wasn’t able to determine whether the specific genetic alterations were present in 31% of patients. Even with a liquid biopsy, ensuring the routine testing of patients for the presence of alterations in DNA repair genes will likely be the biggest barrier to oncologists’ adoption of these drugs in everyday patient care, Dr. Sartor believes.

The above was received in a National Cancer Institute (NCI) Post dated June 12th.


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New Guidelines for Care of Advanced Prostate Cancer

bjgabrielsen : August 5, 2020 1:05 am : 2020, Treatment Information

The American Urological Association (AUA), American Society for Radiation Oncology (ASTRO), and Society of Urologic Oncology (SUO) have released new guidelines for the diagnosis and treatment of advanced prostate cancer, developed by a panel of experts. In addition to their own expertise and experience, panel members assessed data from 264 prostate cancer studies in developing these recommendations for clinical practice.

In total, the panel released 38 individual guidelines, grouped into six overarching themes. These are early evaluation and counseling, recurrence without metastatic disease (local treatment exhausted), metastatic hormone-sensitive cancer, non-metastatic castration-resistant disease, metastatic castration-resistant cancer, and bone health. For the entire July 29th article from Prostate Cancer News Today, see the following link.


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Diet and Prostate Cancer Video

bjgabrielsen : August 2, 2020 4:33 pm : 2020, General Patient Information

In this third video of the PCRI series, Dr. Mark Scholz discusses the role of diet as related to prostate cancer. His overwriting principal is vegetarianism, avoiding animal products. Dr. Scholz bases his conclusion on his observation of patients who lowered their PSA levels while on strict vegan diets. Dr. Scholz also discusses the fact that prostate cancer does not target sugars the way other cancers do. Data from PET scans seem to indicate that prostate cancer seems to feed on fats and amino acids both from animal products. A third observation comes from Chinese studies which indicate that prostate cancer incidence is low in those areas where people eat only small amounts of animal protein. Dr. Scholz concludes that avoidance of animal products and proteins is most important in men with advanced, metastatic tumors. For the entire five minute video, see the following link.


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Bone Metastasis Video from the Prostate Cancer Research Institute.

bjgabrielsen : July 30, 2020 7:38 pm : 2020, General Patient Information

Dr. Mark Scholz, Executive Director of the PCRI, has generated an eight minute video discussing the major issues related to bone metastasis. Bone metastases generally occur in a small percentage of men and can appear 10-20 years after continuous prostate cancer treatment. Bone mets can be observed when the PSA levels exceed 20-30 or hundreds. The best method for detecting bone mets is the PSMA PET scan, if one can obtain access to it. Otherwise, standard bone and CT scans are used which also reveal enlarged lymph nodes. PSMA PET scans reveal metastases up to an 1/8th inch in width while other scans, 1/2 inch across. Bone mets indicate a potential life-threatening condition. Treatments include radiation and various hormone therapies. Fatigue can become a cumulative side effect. Exercise is very important. Bone metastases commonly spread to pelvic or back bone areas and can involve spinal chord compression. Xofigo is an approved drug for more than six metastatic sites; focused radiation can be used for fewer sites. Lutetium is a treatment not yet approved in the US but has been used overseas with some success. For the entire video, see the following link.

As I wrote this post, it hit home to me personally and seriously as I have advanced prostate cancer, with at least one metastatic site. However, my PSA remains very low and I am otherwise asymptomatic. Meanwhile, I am thanking my Lord and Savior Jesus Christ for his continual personal care, His Biblical promise of life eternal in a new heaven and a new earth with a new body and for the extraordinary physicians to which I have access. For additional help, see the following Scriptural Medicines.


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Active Surveillance Video

bjgabrielsen : July 25, 2020 2:03 pm : 2020, General Patient Information

“Active surveillance” perched overlooking a Norwegian fjord. Photo from Shutterstock.

Dr. Mark Scholz, Executive Director of the Prostate Cancer Research Institute (PCRI), has produced three very informative short videos dealing with topics such as 1) active surveillance (AS) for men recently diagnosed with prostate cancer, 2) bone metastasis and, 3) diet and cancer.

This first 7 minute AS video defines the terms “watchful waiting” as compared to “active surveillance”; cites the criteria for AS such as a Gleason 6 score, a PSA <10, and diagnostic procedures using MRI; discusses whether one can be sure of a Gleason 6 diagnosis; the utility of AS for long term care; monitoring of the cancer during AS utilizing periodic biopsies, PSA’s, and high quality MRI’s; signs to discontinue AS including increases in Gleason scores to >6; the use of PSA density; and, finally suggested diets. “Heart healthy diet is prostate healthy.” For the AS video, see the following link.


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New Genetic Risk Test for Prostate Cancer

bjgabrielsen : July 22, 2020 2:59 pm : 2020, Diagnostics, Genetics, Imaging

Using a comprehensive analysis of all the genetic risk data concerning prostate cancer for African American men, Dr. Chris Haiman of the University of Southern California and his team of over 200 researchers were able to determine that it was possible to create an affordable test, based solely on a man’s saliva or blood sample, to assess his risk of developing prostate cancer. The challenge now is to optimize the accuracy of this test and design a way to deliver it to all men.

Information about this test is available from the following link from the Prostate Cancer Foundation. You can also use the following link to sign up for the Smith Polygenic Risk Test and other related information.


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A Large, Free, Virtual Prostate Cancer Conference Available Sept. 11-13, 2020.

bjgabrielsen : July 16, 2020 10:19 pm : 2020, General Patient Information

Pull up a chair and get informed. Overlooking the Gulf of Mexico at Matlacha, Florida. Photo: BJ Gabrielsen.

The annual Prostate Cancer Research Institute (PCRI) Conference is a comprehensive educational experience for prostate cancer patients and caregivers. The conference moderated by Mark Moyad, MD, consists of keynote presentations from leading doctors followed by live question – and – answer sessions. Keynote topics include all treatments, newly-diagnosed, diet and exercise, sexual dysfunction, active surveillance, treatment side effects, prostate imaging and benign prostate hyperplasia (BPH). For the first time, this online event will be live-streamed free! You can attand from the comfort of your own home. You can expect to learn information that will empower you to make the best decisions. You can learn more about this unique educational event at www.pcri.org/2020-conference. To RSVP or subscribe see the following link. You may also contact PCRI at www.pcri.org/get-in-touch.


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Lessons From a Live Oak Tree.

bjgabrielsen : May 26, 2020 10:47 pm : 2020, Encouragement

Two images of my live oak tree in my yard; black bellied singing ducks in lower corner;

This morning I experienced a brief but annoying episode of a recurrent medical issue and potentially a new one. My initial reaction was tension mixed with a little “worry” and “what if”. I have been down that same road before. Almost immediately, God’s Word from James 1:6-7 came to me. “For the one who doubts is like the surf of the sea, driven and tossed by the wind. For let not that man expect that he will receive anything from the Lord.”

In my Florida yard, there are two huge majestic live oak trees suitable for climbing if I were younger (see above). In fact, a friend who is a tree surgeon tells me they are uniquely beautiful in their branch configuration and span. This particular windy morning, I could not help but notice the wide arching, to-and-fro patterns of the mighty branches. But as the branches were swinging wildly driven by the wind pattern and direction, the massive tree trunk never moved. It was firmly planted in the soil. Even during Hurricane Irma a couple of years ago, while branches broke off in parts, the trunk never wavered. My thoughts then refocused to the words of Psalm 1, where it is stated that “the man is blessed…..” who takes refuge “like a tree firmly planted by streams of water.” I saw myself as a branch solidly grafted onto the massive tree trunk. It brought to mind Jesus’ words in John 15:5 where He states that “I am the vine, you (me) are the branches; he who abides in me, and I in him, he bears much fruit, for apart from Me you can do nothing.” I need to consider myself firmly anchored to that massive, unmovable tree trunk (Jesus) whatever winds may blow.

I also noticed that unlike many trees in northern climates, the live oak leaves are deciduous; the tree is never without leaves. As the old leaves fall in March, the new ones immediately appear in their place. The leaves of the tree are constantly being renewed. It reminded me of the truth stated in 2 Corinthians 5:17 that “if any man is in Christ, he is a new creature; the old things” (i.e. tree leaves, personal worries, doubts) ” passed away; behold new things” (i.e. trust, hope, God’s peace) “have come.” So as one who has put his personal faith in Christ thereby enabling a personal relationship with God, I am a new creation; old things and habits do pass away. All becomes new. So as I write this blog to you the readers as well as to myself, whatever our medical conditions, I encourage us to put our faith totally in the unmovable trunk, God and Jesus. Let the old leaves of doubt and mistrust fall away and be replaced by new leaves and fruit of hope, peace and complete trust. As deciduous leaves and branches firmly attached to the unchanging person and nature of God and His Son Jesus Christ, let our minds and thinking be renewed according to the apostle Paul’s words in Romans 12:2. “Be transformed by the renewing of your mind, that you may prove what the will of God is, that which is good and acceptable and perfect.”

“Jesus Christ is the same yesterday and today, yes and forever.” Hebrews 13:8.


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Adding Provenge to Xtandi or Zytiga Reduces Risk of Death by 45% in Metastatic Hormone Resistant Prostate Cancer

bjgabrielsen : May 20, 2020 9:33 pm : 2020, Treatment Information

Data from more than 6,000 Medicare patients showed that adding the immunotherapy Provenge (sipuleucel-T) to a regimen containing the oral agents Zytiga (abiraterone acetate) or Xtandi (enzalutamide) significantly extended the lives of men with metastatic hormone-resistant prostate cancer (mCRPC). The findings were presented in a poster at the recent American Society of Clinical Oncology (ASCO) 2020 Genitourinary Cancers Symposium in San Francisco, California.

Provenge, marketed by Dendreon Pharmaceuticals, is an immunotherapy that uses a patient’s own immune cells to fight prostate cancer. In it, a fraction of white blood cells that have been exposed to a prostate cancer protein are primed to activate the remaining immune cells to fight cancer. Provenge is the only immunotherapy approved in the U.S. (2010) for prostate cancer that is made from a patient’s own immune cells. Since 2010, second-generation androgen receptor inhibitors, like Zytiga and Xtandi, have become the standard care treatment for men with mCRPC. This led researchers at Dendreon to assess the benefits of Provenge when used in combination with these agents. The researchers examined medical and pharmacy claims from 6,853 Medicare mCRPC patients who had not received any prior treatment, which means they had no treatment claims in the prior year.

Results indicated that the use of Provenge significantly extended patients’ lives from 20.7 months to 35.2 months. This 14.5-month increase in overall survival represented a 45% reduction in the risk of death. Notably, the benefits were seen at any point during treatment, with patients receiving Provenge as part of their first-line treatment seeing the same extension in overall survival as those receiving the therapy in later lines. At three years, nearly half (48%) of patients receiving Provenge in any line of treatment were alive, compared to 28% of those receiving only Zytiga or Xtandi without Provenge.

Recent findings from an observational registry study called PROCEED also showed that men with asymptomatic or minimally symptomatic mCRPC derive the same benefits from Provenge as those that had been demonstrated in IMPACT. Men with low prostate specific antigen (PSA) levels at baseline fared particularly well, living nearly four years after receiving Provenge.

This is in line with another study also presented at the ASCO GU Cancers Symposium, demonstrating that Provenge works better in men with early-stage prostate cancer — who likely have lower PSA levels — than in those with mCRPC.

“These real-world data contribute to a growing body of evidence that Provenge continues to deliver on its promise of helping men with advanced prostate cancer live longer,” said Bruce A. Brown, MD, chief medical officer at Dendreon.

Several blogs describing Provenge including my own experience with it have been posted on this website. See the following links from 2017, 2014, and 2011.

A portion of the above was an excerpt from the Feb. 20th Prostate Cancer News Today, by Iqra Mumal. I strongly encourage readers to subscribe to this e mail prostate cancer news service.


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Put Your Hope in God

bjgabrielsen : April 27, 2020 10:55 am : 2020, Encouragement

Several years ago, I experienced an annoying side effect which had arisen related to earlier prostate cancer therapy. The side effect had been “cured” by a specific series of treatments but now it had reared its troublesome head again. One recent Sunday, it was especially troublesome. There are potential treatments for this condition but my excellent Johns Hopkins urologist told me that living with the condition is probably better than medically trying to make everything perfectly normal. “Perfection is the enemy of good”, he stated. So I spent the Sunday dejected and asking God why He had allowed this unwelcome side effect to arise again when it had been so well controlled four years earlier. In the course of a disease, when these disappointments happen, my mind and emotions sink into a mild depression and some degree of anger all of which last 2-3 days after which I acknowledge the situation and resolve to carry on my life as normally as I possibly can.

A day or two later, I read a devotional from Our Daily Bread, April 20, 2020. In Psalm 42, we gain a window into the human spirit as it engages in a profound emotional struggle often related to our disease state. The author of the Psalm copes with his personal crisis by first acknowledging his desperate need of God. I saw a clear picture of myself in this Psalm. The writer of Psalm 42 begins by acknowledging that he needs divine help in his condition by writing in verses 1-2 “As the deer pants for streams of water, so my soul pants for you, my God. My soul thirsts for God, for the living God.” Then he outlines his problem. In his predicament, the Psalmist writes “when can I go and meet with God?” It is as if he is asking “where are you God in all of this?” While my condition was not painful, the writer, like myself, was distraught and disappointed, writing in verse 3 “my tears have been my food day and night.”

Then the Psalmist recalls better days when all was under control and he was living a peaceful life. I could relate to the following “These things I remember as I pour out my soul: how I used to go to the house of God (my church) under the protection of the Mighty One with shouts of joy and praise among the festive throng.” Even though I was experiencing my problem on a Sunday, I was definitely not filled with joy and praise. Instead, like the writer in verse 5, I was saying “my soul, why are you downcast? Why so disturbed within me?” Looking back on God’s unfailing goodness to him in the past, the Psalmist challenges himself: “Why, my soul, are you downcast?” But then, he comes up with the solution. Instead. . . “Put your hope in God.”

For me, one day later, the dawn broke, bright and fair. I could express my hope as the Psalmist wrote in verse 5 ” Put your hope in God for I will yet praise him, my Savior and my God.” In our spiritual and medical struggles, our emotions must be acknowledged. It’s healthy to be completely honest before God, and it’s vital to keep our focus on Him in our emotional anguish. The Psalms were written by people like David who were at times overwhelmed with despair and confusion yet they exhibited a faith-filled confidence in God’s great love, His presence and faithfulness. That’s why we so readily identify with the psalms.

When I look into the sky on a clear night, I can see the stars like the Big Dipper, perfectly aligned in a pattern even though they are millions of light years away. But then, I realized that if I were actually closer to those stars, they would not appear to be so clearly aligned in a pattern. Yet from my distant perspective, they looked carefully configured in the heavens. At that moment, I realized that when I am too close to the negative events in my life and see only my dire situation, I don’t see what God sees. In His big picture, everything is in perfect alignment. His ways are beyond our limited ability to understand or visualize. Yet the One who holds all things together in the heavens and on earth is intimately and lovingly involved with every detail of our lives. Therefore, we “hope in God for we will yet praise him, our Savior and our God.”

If you are unsure of your own personal relationship with this God to whom this post refers, see the following.


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When Most Needed, An Unexpected Letter

bjgabrielsen : April 11, 2020 4:05 pm : 2020, Encouragement

If two ospreys, created by God Himself, guard their nest as jealously as they do, how much more doesn’t God watch us who hold on to Him? Photo: Bjarne Gabrielsen

This post is very personal to me and provided me with encouragement at this time of personal need. While I am currently asymptomatic, for which I am immensely grateful, I know I have metastatic sites of prostate cancer in my body. Upon a recent visit to my oncologist, he calmly but coldly and clinically told me that I have Stage 4 advanced prostate cancer which really scared me. It took about 2 days for the shock to calm down and for my stomach muscles to fully relax.

In 2007, I experienced a biochemical recurrence of prostate cancer which had supposedly been removed surgically in 1995. Subsequent radiation also failed to totally remove all traces of cancer. Fear gripped my life at that point. Meanwhile, I received an unexpected letter from the wife of the pastor of our country church in Maryland which spoke volumes to me in 2007 and then again today in 2020. I’d like to share a portion of it with you my readers and anyone else who could benefit from its contents.

She wrote as follows. “When an angel appears to someone in the Bible, often the first words out of its mouth are ‘do not be afraid.’ It happened that way to Mary and Joseph, the shepherds in the field, and the two Marys at Jesus’ empty tomb as well as to numerous Old Testament characters. If an angel were to appear to me, I would want to hear those same words. Actually, the phrase ‘do not be afraid’ is reiterated over and over in the Bible which contains 365 commands to ‘fear not’. I think that’s because God knows how prone we are to be afraid anytime we meet up with something we don’t understand or cannot control.

The term ‘do not be afraid’ is invariably linked Biblically with a phrase describing one of God’s characteristics; His presence, His power, His past performance or His promise. ‘Do not be afraid for I am…., or for I will.’ Apparantly, the antidote to fear is the knowledge that God is with us, is powerful and promises to help us. Isaiah 41:10 states ‘do not fear for I am with you; do not be dismayed for I am your God. I will strengthen you and help you; I will uphold you with my righteous right hand.'”

My pastor’s wife continues. “When I was a very little girl, my dad used to take me for walks. My hands were still very tiny and his hands were very large. I would hold onto one of his fingers so that I wouldn’t fall. But my dad knew that wasn’t enough, for if I started to tumble I could easily lose my grip on his finger. He used to let me hold his finger but then he would wrap his other big fingers around my little hand so that even if I let go, he would still be holding on to me. He said that was a picture of the way God holds us with His big hand. Yes Lord”, she continued, “hold my hand tightly. I’m holding on to you but even more important I’m glad you’re holding on to me more than ever when I am afraid.”

So now, I am finding that the posts I am writing serve not only to hopefully encourage other men with medical issues like mine, but they serve to provide strength and encouragement for myself as I read them again. If you want to read any of the previous Encouragement posts, simply go to the Godandprostate.net home page and enter the word “Encouragement” in the search area. If you are unsure of your personal relationship with such a God and His Son, Jesus, see the following link.


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A Life of Peace

bjgabrielsen : April 4, 2020 5:27 pm : 2020, Encouragement

This website usually focuses exclusively on prostate cancer but this particular post could apply to the current worldwide coronavirus pandemic as well.

Right now we as a nation and many of us as individuals may have a potential medical problem that has our stomach in knots with persistent worry. For most of us, it is the COVID-19 virus and its consequences but for many of us men it might also be cancer. We may be so focused on our situation that it feels like we’re carrying a heavy load on our shoulders. The Lord offers a liberating alternative: “Cast your burden upon [Me] and [I] will sustain you” (Psalm 55:22). Though God doesn’t erase all the ills that invade this life, He instead shields us from the weight of worry by taking our situation into His own hands.

However, the call to a peaceful life is impossible without confidence in the Lord. That trust is built through a relationship with Him, praying through trials and triumphs, seeking His guidance, and testing His Word to see that it is true and practical for life.

When we’ve experienced God’s faithfulness and believe He will continue to act on behalf of His followers, that’s when peace is possible. “No eye has seen any God besides you who acts on behalf of those who wait for Him” (Isaiah 64:4). In fact, peace is not only possible but promised to the believer who trusts in Him. Philippians 4:6-7 states “do not be anxious about anything, but in everything, by prayer and petition with thanksgiving, present your requests to God. And the peace of God, which transcends all understanding, will guard your hearts and minds in Christ Jesus.” But unshakeable peace isn’t instantaneous; it is cultivated through a consistent relationship with the Lord.

May we as a nation and as individuals place our trust in the words of Isaiah 26:2-4 which states as follows. “Open the gates that the righteous nation may enter, the nation that keeps faith. You will keep in perfect peace him whose mind is steadfast, because he trusts in You. Trust in the Lord forever, for the Lord, the Lord, is the Rock eternal.”

Much of this post was an excerpt from the February 26th, 2020 devotional from In Touch Ministries by Dr. Charles Stanley.


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Molecular Imaging PSMA PET/CT Could Transform Management of People with Aggressive Cancer

bjgabrielsen : April 1, 2020 12:10 am : 2020, Diagnostics, Genetics, Imaging

Upon recent discussions with my urologist and oncologist, they both informed me that the following is a highly significant development in imaging of prostate cancer.

A medical imaging technique, known as PSMA PET/CT, that provides detailed body scans while detecting levels of a molecule associated with prostate cancer could help doctors better tailor treatments for their patients, by determining the extent of disease spread at the time of diagnosis. This was the finding of a randomized, controlled trial involving 300 patients in Australia recently published in The Lancet journal.

The approach combines two imaging technologies – positron emission tomography (PET) and computed tomography (CT) – and is almost one third more accurate than standard CT and bone scans at pinpointing the spread of prostate cancer throughout the body. PSMA PET/CT proved to be 92% accurate compared with only 65% accuracy with standard imaging. Although the study did not assess whether the scans had any effect on patient survival, the researchers say this approach could improve outcomes by helping doctors decide whether to offer a localized treatment, such as surgery or radiotherapy, or to use more advanced treatments to treat the whole body if the cancer has already spread.

Prostate cancer is commonly treated by surgery to remove the prostate or intensive radiotherapy to target the tumor. If there is a high risk the cancer may have spread to other parts of the body, patients may be offered medical imaging – typically CT and bone scans – to help doctors determine if additional treatments are needed. Study lead Professor Michael Hofman of the Peter MacCallum Cancer Centre, Melbourne, said: “Taken together, our findings indicate that PSMA-PET/CT scans offer greater accuracy than conventional imaging and can better inform treatment decisions. We recommend that clinical guidelines should be updated to include PSMA PET/CT as part of the diagnostic pathway for men with high risk prostate cancer.” Both imaging techniques involve exposure to radiation but the dose associated with PSMA-PET/CT was less than half that associated with conventional imaging (8.4mSv vs 19.2mSv).

Researchers sought to investigate if a molecular imaging approach could help doctors better define the extent of disease at the time of diagnosis. This approach involves giving patients a radioactive substance that detects a molecule called Prostate Specific Membrane Antigen (PSMA), which is found at high levels on prostate cancer cells. They then undergo a PET/CT scan. The CT scan produces detailed images of the body’s organs and structures, while the PET scan lights up areas where PSMA is present at high levels, indicating the presence of prostate cancer cells.

The study involved 300 men recruited to ten sites across Australia. All of the men had been diagnosed with prostate cancer, confirmed by tests on prostate tissue samples, and were deemed to be at high risk of having aggressive disease. The men were randomly assigned to receive either conventional CT and bone scans (152 patients) or PSMA-PET/CT (148 patients). Men then swapped over and were given the scans using the alternative imaging arm unless more than three sites of cancer spread were detected on the initial scans (18 patients). A second round of scans were undertaken at six months if there was any concern about ongoing prostate cancer following treatment. The results of these scans were used to confirm tumor spread, in addition to biopsies and change in blood tests.

Overall, the researchers found the PSMA-PET/CT scans were much more accurate than conventional CT and bone scans at detecting cancer spread (92% vs 65%). This is because the new technique was better at detecting small sites of tumor spread. Conventional imaging failed to detect that the cancer had spread in 29 patients, giving a false negative result. By comparison, PSMA-PET/CT gave false negative results in just six patients. Furthermore, fewer men had false positive results obtained with the new technique (2 with PSMA-PET/CT and 9 with conventional imaging)

PSMA-PET/CT scans had greater impact on the way patients’ disease was managed, with 28% having their treatment plans changed after the scans (41/147) compared with 15% following conventional imaging (23/152). When PSMA-PET/CT was given at the second round of imaging after conventional imaging, disease management plans were still changed in more than a quarter of cases (39/146, 27%). When conventional imaging was used at the second round, however, just 5% of patients had their treatment plans changed (7/135 patients).

Professor Declan Murphy, senior author, of Peter MacCallum Cancer Centre, Melbourne, said “Around one in three prostate cancer patients will experience a disease relapse after surgery or radiotherapy. This is partly because current medical imaging techniques often fail to detect when the cancer has spread, which means some men are not given the additional treatments they need. Our findings suggest PSMA-PET/CT could help identify these men sooner, so they get the most appropriate care.”

For further details, see the following from the Prostate Cancer Foundation, March 22, 2020.


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Rubraca Granted FDA Priority Review for Advanced Prostate Cancer in Men with BRCA Mutations

bjgabrielsen : March 25, 2020 8:30 pm : 2020, Treatment Information

The U.S. Food and Drug Administration (FDA) has granted priority review to Clovis Oncology’s application seeking approval of Rubraca (rucaparib) for treating men with recurrent metastatic castration (hormone)-resistant prostate cancer (mCRPC) and BRCA mutations.

Clovis submitted its application to the FDA in November, 2019. The priority review status will shorten Rubraca’s regulatory review for this indication to six months from the standard 10 months.

Nearly 12% of men with mCRPC have a mutation in the BRCA1 or BRCA2 genes, which are involved in DNA repair. These tumors rely on other DNA repair mechanisms — including those involving PARP enzymes that act as DNA damage sensors — to survive and grow. Thus, treatments that block PARPs’ activity (PARP inhibitors), such as Rubraca, are particularly effective in BRCA-mutated tumors. Rubraca is already approved for the treatment of several gynecologic tumors carrying BRCA mutations, and as a maintenance therapy regardless of BRCA mutations.

Rubraca’s new application was supported by data from the TRITON2 Phase 2 trial (NCT02952534), which is evaluating its safety and effectiveness in up to 360 mCRPC patients with mutations in BRCA genes or in other 13 DNA repair genes known to increase susceptibility to PARP inhibitors.

Besides eligible mutations, participants must have experienced disease progression after at least one but no more than two previous androgen-receptor targeted therapies and one prior taxane-based chemotherapy for their castration-resistant disease.

TRITON2’s main goals were to assess overall response rates in men with measurable disease, and the proportion of men who saw a reduction in the levels of prostate-specific antigen (PSA) — a biomarker of prostate cancer — after treatment. Secondary goals included duration of response, time to disease progression or death, overall survival, and safety measures.

Early positive data from TRITON2 led to Rubraca’s breakthrough therapy designation by the FDA for the treatment for mCRPC patients with BRCA mutations, a status intended to accelerate the therapy’s development and review. As of Feb. 28, 2019, 190 patients (98 with a BRCA mutation) had received Rubraca, with a median follow-up of 13.1 months. Among patients with BRCA mutations, results showed that 43.9% of those with measurable disease responded to treatment, and that 60% of these responses lasted at least 24 weeks. Also, 52% of patients had a confirmed PSA response (deemed as a 50% or greater reduction in PSA levels), which lasted a median of 5.5 months.

Rubraca’s safety profile was consistent with prior reports from TRITON2 and other trials, with the most common adverse events being fatigue (55.3%), nausea (49.5%), anemia (37.9%), decreased appetite (27.9%), transient increase in liver enzymes (24.7%), constipation (24.7%), vomiting (22.1%), and diarrhea (21.1%).

The preceding was an excerpt from Prostate Cancer News Today, Jan. 16th by Dr. Marta Figureiredo.


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Responding to Life’s Storms

bjgabrielsen : March 8, 2020 1:09 pm : 2020, Encouragement

God provides for all His creatures; photo: BJ Gabrielsen

How do you react in a severe storm or if you receive bad news? Do you tense up with fear or do you recall words such as those in Psalm 107:28-30? “Then they cry out to the Lord in their trouble, and He brings them out of their distresses. He calms the storm, so that its waves are still. Then they are glad because they are quiet; so He guides them to their desired haven.”

Personally, the year 2019 was filled with medical challenges. In addition to my 24-year issue with prostate cancer, physicians speculated that I may have bladder cancer as well. When I received this news, I did indeed tense up with fear and uttered the following to God. “Why this too? Isn’t one type of cancer enough?” I discovered that when one gets bad news, it usually takes 2-3 days before the initial shock subsides and I can then more calmly refocus on God’s presence.

Life’s storms can either stunt or accelerate our spiritual growth. The determining factor is our reaction. Some people humbly cry out to the Lord, while others get angry or frustrated with Him and their circumstances. Still, others ignore God and try to figure things out on their own, seeking solutions in every place except God’s Word.

Turning away from the Lord results in a hardened heart for someone who does not have a personal relationship with Him; for a believer, turning away results in spiritual discipline. God wants us to be surrendered to His will whatever the occurrence, because if we are proud, doubting Him or self-reliant, then we aren’t useful for His glory and purpose for our lives. That is why God brings storms across our path- to teach us to fully rely on Him.

When the Lord allows adversity in your life, do you accept it as something designed for your good? Or do you try to bend God to conform to your own will? As difficult as they may be, storms are meant to produce godly character in us. In my own case, why was the storm of potential bladder cancer to be used for my good? After a period of intense questionning of God and His care for me, I was specifically led to Jesus’ prayer to His Father just prior to His crucifixion as payment for all our sins. In Mark 14:36. Jesus intensely prays, “Abba Father, all things are possible for You. Take this cup away from Me; nevertheless, not what I will but what You will.” After some days of struggle, first I likewise fully acknowledged to God that He has the power to eliminate any traces of cancer from my body. I may not witness many dramatic cancer healings today but God indeed has the power to do so if He desires. All things are possible for Him. Second, as in Jesus’ prayer, I pleaded that He take any vestiges of bladder cancer away from my body. Thirdly, and most importantly, I affirmed that even if cancer were to be found, I would trust His care and His will in my life. After a CT scan and a thorough visual examination of my bladder by my urologist, no cancer was revealed. Instead, I had some fragile blood vessels induced as a side effect of previous radiation therapy. Under God’s direction and ministry to me, I had weathered this storm and learned a valuable lesson to pattern my personal prayer to that of Jesus Himself when the next storm arises.

If you are unsure of a personal relationship with God through faith in Jesus, then this post might seem foreign to you. Coming to know God and His Son Jesus in a personal and unique way is the place to start.

A portion of the above was an excerpt from the January 8th, 2020 In Touch Ministries devotional by Dr. Charles Stanley.


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