2014 Blog

Phase 2 Clinical Trial Demonstrates Benefits of Metformin in Prostate Cancer.

bjgabrielsen : March 25, 2014 4:01 am : 2014, General Patient Information

In a study published in the January 4th, 2014 issue of the journal, European Urology, Swiss researchers found that treatment with the anti-diabetic drug metformin in patients with hormone-resistant prostate cancer increased their progression-free survival and prolonged PSA doubling time. The one-year study included 44 men who were given 1,000 mg (1 gram) of metformin twice daily. After 12 weeks of treatment, 36% of patients were progression-free with over 25% of these men remaining progression-free at 24 weeks. Over 52% of the patients experienced a prolongation of PSA doubling time reflecting slower tumor growth. Additionally, insulin sensitivity markers improved by 26% in the first 12 weeks of treatment. The researchers concluded that treatment with metformin is safe in non-diabetic patients. Metformin’s low cost, favorable toxicity profile and positive effect on metabolic parameters warrants further investigation as a treatment for prostate cancer.


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A Life of Peace

bjgabrielsen : March 9, 2014 4:35 am : 2014, Encouragement

The following was written by Dr. Charles Stanley, pastor of the First Baptist Church of Atlanta, and printed as the Feb. 25th, 2014 devotional of In Touch Magazine. It applies very well to any man dealing with prostate disease.

“Your home offers protection from the elements. So when a storm rolls in, you seek shelter within the safety of those four walls. The same principle applies to life’s storms. If we’ve built a solid house on a foundation of faith, then we’ve got a haven to run to when dark clouds gather and anxiety threatens to overwhelm us.

Let’s suppose a problem” (such as prostate cancer) “is worrying you, and your stomach is in knots. Friends and family try to be understanding,” but they have never experienced a similar diagnosis. “You are so focused on the issue that it feels as if your shoulders are bearing a heavy weight. Now listen to the liberating alternative God offers: ‘Cast your burden upon [Me] and [I] will sustain you’ ( Psalm 55:22). He doesn’t erase the ills that invade this life. Instead, He shields us from the weight of worry by taking situations into His own hands.

However, the call to a free and peaceful life goes unheeded unless a person has confidence in the Lord. Trust is built through relationship—praying during daily trials and triumphs, seeking biblical guidance for decisions, and testing God’s Word to see that it is true and practical. That’s how a house of faith is constructed brick by brick on the solid rock of Jesus Christ.

A believer who trusts in the Lord receives the peace that Isaiah 26:3-4 promises. ‘The steadfast of mind Thou wilt keep in perfect peace, because He trusts in Thee. Trust in the Lord forever, for in God, the Lord, we have an everlasting rock.’  But unshakeable peace isn’t instantaneous; it is cultivated through a consistent relationship with God. A lifestyle of dependence upon Him is the key to weathering storms with supernatural calm.


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Phase 2 or 3 Clinical Trials for Men with Hormone-Resistant, Metastatic Prostate Cancer.

bjgabrielsen : February 22, 2014 4:54 am : 2014, Treatment Information

The Prostate Cancer Research Institute (PCRI) recently published the particulars for four clinical trials (Phases 2 and 3) for men with metastatic, castrate-resistant (i.e. PSA progressing with reduced testosterone) prostate cancer.  The first Phase 2 trial involves treatment with Enzalutamide (Xtandi or MDV 3100) administered with or without Prostvac.  For a brief summary of these therapeutic agents and how they work, see the January 3rd, 2012 website blog.  The second is a trial involving the co-administration of Indoximod and Provenge (Sipuleucel).   Indoximod is an agent that targets mechanisms by which tumors evade the immune system.  The third trial (termed PROMOTE) is studying the gene expression patterns of castrate-resistant patients currently receiving treatment with Zytiga (abiraterone acetate).  The fourth is a Phase 3 trial of Prostvac with or without GM-CSF (granulocyte macrophage colony stimulating factor), a protein that functions as a white blood cell growth factor.  For additional information, see the links in this blog.  For overall clinical trials information, see (1) http://www.clinicaltrials.gov and specifically search for prostate cancer trials;  (2) http://www.cancer.gov, a site from the National Cancer Institute, National Institutes of Health; or, (3) for trials being conducted solely in the state of Florida, see http://www.Flcancer.com.


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Targeted Radiotherapy for Men with Micro-Metastatic, Advanced Prostate Cancer. Phase II Clinical Trial Information.

bjgabrielsen : February 21, 2014 6:21 am : 2014, Treatment Information

Scientists at Weill Cornell Medical College in New York have attached a chemical tag (the isotope lutetium-177) that emits small amounts of radiation onto a monoclonal antibody (J591) that targets prostate cancer cells in bone, soft tissues and circulating blood that carry the protein antigen, prostate-specific membrane antigen (PSMA).  Treatment with 177Lu-J591 may be optimally suited to patients with micro-metastatic disease.  The developers of this therapy postulate that such treatment in men who have small volume disease not seen on bone scans could even result in a cure for some patients. They specifically refer to men who have had surgery and/or radiation at their primary prostate tumor site who are then experiencing rising PSA levels (biochemical failure) but their bone and CT scans remain negative for metastatic cancer.  Results of a Phase II clinical trial of 177Lu-J591 in men who had failed hormonal therapy are summarized in a Jan. 31st, 2014 article from the Prostate Cancer Foundation (PCF).  A subsequent Phase II clinical trial at Weill Cornell Medical College and twelve other centers is underway to determine if 177Lu-J591 can delay or prevent overt metastatic disease in men with rising PSA levels after primary treatment and early hormonal therapy but in whom bone and CT scans remain negative.  The PSMA antigen is also expressed in other tumors such as liver, breast and kidney; hence this targeted radiotherapy could possibly be used in tumors other than prostate cancer.  For further details, see the linked PCF article.

 


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Coffee, Caffeine, PSA Velocity and Hormonal Therapy.

bjgabrielsen : February 18, 2014 12:09 am : 2014, General Patient Information, Treatment Information

As we have come to expect, the Johns Hopkins Medicine Health Alerts always contain useful information for prostate cancer patients.  For example, the January 19th, 2014  issue contained a primer describing the basic concepts and rationale of hormonal therapy.  The February 9th edition reported three published studies which link coffee drinking and caffeine to a risk reduction for several types of cancer including aggressive prostate cancer, and its recurrence and progression.  Thirdly, the February 16th issue described a study that concluded that PSA velocity (the rate of PSA change over time) “accurately predicted which men would develop prostate cancer and was significantly more accurate than a single PSA measurement in predicting which men would develop aggressive disease.”


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Prostate Biopsies

bjgabrielsen : February 17, 2014 4:15 am : 2014, Diagnostics, Genetics, Imaging

I recently heard an interesting talk given by my local urologist in which he traced the history of prostate biopsies to detect cancers.  I’d like to share a couple of insights that I learned.  When my own cancer was first detected in 1995, the surgeons collected six samples via the trans-rectal route.  I assume that at that time, this was the standard protocol.  Currently, I understand twelve samples is the norm.  However, my urologist stated that the trans-rectal route can easily miss cancers located in the anterior tissues of the prostate gland.  Therefore, he recommended that the best route for biopsies is trans-perineal, i.e., the genital area between the scrotum and anus.  This route provides better access to the anterior prostate.  He also mentioned that a value called PSA-density, i.e. the amount of PSA produced per volume of gland, continues to be a useful indicator of possible malignancy.  PSA density values have been used since the 1990’s.  In fact, without realizing it personally, I had used it in my own case in 1995.  An ultrasound had revealed that my prostate was not especially enlarged yet my PSA was consistently somewhat high in the 4.o ng/ml range.  Naively, I reasoned that if a smaller gland was producing a higher than normal amount of PSA, something might be wrong.  I was correct.  Numerical guidelines for PSA densities are available though I don’t have that information at hand.  My urologist also discussed the increasing use of magnetic resonance imaging (MRI) in guiding biopsies and delineating the prostate and surrounding tissues.  An excellent overview of prostate MRI was written by UCLA Radiologist Dr. Daniel Margolis and published in the November, 2010 issue of the Prostate Cancer Research Institute (PCRI) Insights.  An on-going clinical trial at the National Cancer Institute using MRI-guided focal therapy to treat low-risk, localized prostate cancer was also posted on this website on July 11th, 2012.


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Deep Waters Can be Safe and Peaceful

bjgabrielsen : February 13, 2014 4:51 am : 2014, Encouragement

Boca Pass between Charlotte Harbor and the Gulf of Mexico at Boca Grande, Florida. Cayo Costa in the background. BJ Gabrielsen photo.
Boca Pass between Charlotte Harbor and the Gulf of Mexico at Boca Grande, Florida. Cayo Costa in the background. BJ Gabrielsen photo.

There are some highly interesting medical news items to be posted in the next week or so but I first need to share the following.  I was raised near the east end of Long Island Sound and learned to swim at a young age. When my parents would hold me up in shallow water where I could touch bottom, there was little challenge. That was easy. But soon, they would take me into deeper water above my head. Even as the waves would splash in my face, I remained very calm with complete trust as long as I was in my parent’s grasp.  As men who are facing prostate cancer, we can think of ourselves as being in “deep waters”.  Our condition is not something we would have wished for ourselves. In the book of Luke chapter 5, verses 1-11, Jesus’ disciples had fished all night without success. But when the Lord challenged them to head into deeper waters, they caught fish in abundance beyond their wildest expectations. Deeper waters can be a source of blessing. As Christians, we can waste our lives standing on the shoreline never venturing beyond ankle-deep water. There we need little help from the Lord. But when we find ourselves in deeper waters, we need God desperately. When we are in the deeper waters of prostate cancer, we find we must relinquish control of our lives. While we can seek to maintain our bodies in the best ways possible by nutrition, exercise and medications, we can no longer determine our own fate.  To the Christian (meaning one who has a personal relationship with God through faith in Christ), God is our captain who upholds us with His strong hands just as my parents did for me as a child learning to swim.  The surrendered believer experiences God and Christ more intimately than someone on shore can; we can receive a boatload of God’s goodness and blessings. We must hold fast to the truth that God will never remove His hand of support and strength from us.  Jesus’ own words (John 10:27-29) bear witness to this fact. “My sheep hear My voice and I know them…..and I give eternal life to them; and they shall never perish; and no one shall snatch them out of My hand. My Father (God), who has given them to Me, is greater than all; and no one is able to snatch them out of the Father’s hand.”

Have we as individual Christians actually submitted our conditions to the Lord?  Charles Stanley writes that “we often want to cling to a measure of control in case God doesn’t work events to our satisfaction. Too many Christians are content merely to dip their toes into faith because they fear life might not turn out according to their plan. But how much greater their loss will be if life doesn’t turn out according to God’s plan. He can do much more with a surrendered existence than a sheltered one.”  The process of surrendering our condition to God is a continuous, daily one.  Visualize packaging the prostate cancer and laying it at the foot of Christ’s cross and leaving it there.  Alternatively, place it in a box (called God’s box by one author), and depositing it in the box and locking it. The Christian life, even to a prostate cancer patient, becomes exciting when we wade into water so deep that our feet no longer touch the bottom. Then all we have to stand upon are God’s promises, but they are more than enough.


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1) Financial Assistance for Prostate Cancer (PC) Patients; 2) Three New Commercially-Available Genetic PC Tests; 3) Phase 2 Clinical Trials for Metastatic PC Patients.

bjgabrielsen : January 10, 2014 8:41 pm : 2014, Diagnostics, Genetics, Imaging, General Patient Information

Fishing for information? Cornfield in Middletown Valley, Maryland; BJarne Gabrielsen photo
Fishing for information? Cornfield in Middletown Valley, Maryland; BJarne Gabrielsen photo

1) Payment Assistance for Under Insured Patients. The Patient Access Network (PAN) Foundation offers financial assistance to prostate cancer patients who lack full insurance coverage, allowing access to treatments previously out of reach. In 2012, PAN started an initiative to raise funds to provide castrate-resistant patients access to new and necessary treatments. To date, 2,200 men have enrolled and $22 million in financial assistance has been allocated. Current co-pay programs include treatments involving androgen receptor inhibitors,  immunotherapy, radioisotope and metastatic castrate-resistant prostate cancer. Travel assistance for treatments are also available. Application information and details can be found in the November 2013 PCRI Insights. 

2) Three new, commercially-available genetic tests for prostate cancer. Prolaris from Myriad Genetics and Oncotype Dx from Genomic Health can help obtain a more accurate measure of tumor aggressiveness. Both tests examine multiple genes in prostate cells that are removed at the time of biopsy. Polaris predicts the risk of ten-year mortality from prostate cancer while Oncotype Dx seeks to more precisely define the risk category of the individual prostate cancer. A third, Confirm MDx from MDxHealth can provide additional assurance that a negative biopsy is truly negative and that the needle did not simply miss the cancer. It is as accurate as a second biopsy without the unwanted complications.

3) Several specific open Phase 2 clinical trials for men with castrate-resistant, metastatic prostate cancer  are listed in the November 18th, 2013 PCRI Insights. These trials involve new therapeutic agents such as Provenge, Xofigo and Cabozantinib (XL184). Enrollment information, criteria and locations are found in the Nov. 18th issue.

As always, your reader comments are valued. You can also sign up for automatic receipt of blogs as they are posted. See the home page.

 


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Radiation Therapy Meeting Highlights; IMRT Review.

bjgabrielsen : January 9, 2014 7:07 am : 2014, General Patient Information, Treatment Information

PCRI Insights is published monthly by the Prostate Cancer Research Institute (PCRI) and is must-reading for men with prostate cancer. The November 2013 issue featured a summary of several pertinent abstracts of presentations given at a recent annual meeting of radiation therapists. One abstract presented cure rates achieved with intensity modulated radiation therapy (IMRT) combined with a boost from seed implants. IMRT is a refinement over existing radiotherapy modalities providing for a higher dose of radiation to the tumor while exposing surrounding tissue to less radiation. An excellent review of IMRT has been published in Cancer News. Another study compared the preservation of potency in young men treated with radiation as compared to surgery. A third study and commentary addressed the issue of when radiation therapy should be commenced after PSA relapse. Other abstracts addressed the issue of the timing of the use of hormone blockade accompanying radiation therapy. The final study examined the effect of the rate of PSA doubling on survival rates and times in relapsed prostate cancer patients originally treated with IMRT. Finally, it should be noted that the studies presented here focused on radiation therapy. A man considering treatment for prostate cancer is urged to consider additional modalities before deciding on a specific, personal course of treatment.


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Highlights of 2013-continued. Inflammation,Diet and Prostate Cancer; FDA Approvalof Xofigo; and, a Guide to Genes and Prostate Cancer.

bjgabrielsen : January 4, 2014 6:18 am : 2014, Diagnostics, Genetics, Imaging, Treatment Information

Chronic inflammation is suspected to play a role in numerous diseases such as heart disease, Alzheimer’s, arthritis and cancer. If this is the case, then could reducing chronic inflammation by dietary means reduce the incidence of prostate cancer for example? This question is being studied extensively and is the focus of an article in the December 20th issue of the Prostate Cancer Foundation NewsPulse. Researchers at Johns Hopkins are studying  prostate cells as they transition from normal to pre-cancerous and finally to cancerous. They speculate that inflammation may be an early factor inducing healthy prostate epithelial cells into the cancerous cycle. Since obesity is already linked to an increase risk of death from prostate cancer, could an anti-inflammatory diet have an effect on the incidence and severity of prostate cancer? A diet similar to the Mediterranean diet may be of help and is described in the NewsPulse article. Helpful foods include whole grains, healthy fats (as opposed to animal or trans fats), fruits and vegetables, spices such as ginger, garlic, cinnamon, and curcumin, green or oolong tea, nuts such as walnuts, oil-based salad dressing, omega-3 fatty acids derived from vegetable oils or flaxseed (as opposed to fish such as salmon), and others in the PCF article. While the anti-inflammatory diet includes many foods that may have health benefits for men with prostate cancer, further research is needed into specific components  and the dietary patterns as a whole in order to assess how this diet may affect men with prostate cancer. As always, be advised to consult with your medical professional.

A second major story in this year-end issue of the PCF NewsPulse cites the FDA approval in spring, 2013 of Xofigo, radium-223-chloride, also known as alpharadin for the treatment of men with advanced metastatic prostate cancer. Xofigo extends survival, improves quality of life, requires less opioid medication for bone pain and its resulting side effects, and reduces complications such as spinal cord compression and bone fractures which result from bone tumors. Additional information is available in the accompanying article. This website has also posted information on this agent in previous blogs dated November 5th, 2011, January 3rd, 2012, April 28th, 2012 and June 3rd, 2013.

The third article from NewsPulse provides an excellent summary of a number genes and their proposed involvement in prostate cancer. Specific genes include HOXB13 (associated with hereditary prostate cancer), the female breast cancer susceptibility genes BRCA1 and BRCA2, the fused genes TMPRSS2-ERG and others. This review would be useful for physicians as well as laymen.


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