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

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) and specifically search for prostate cancer trials;  (2), a site from the National Cancer Institute, National Institutes of Health; or, (3) for trials being conducted solely in the state of Florida, see

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


Coffee, Caffeine, PSA Velocity and Hormonal Therapy.

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.”

Prostate Biopsies

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.

Deep Waters Can be Safe and Peaceful

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.