November News Items: 1) Watchful-Waiting; 2) New drug TAK-700; 3) Use of Cryotherapy After Failure of Radiation or Brachytherapy.

1) The November 16th, 2011 issue of the Newsletter from Zero-The Project to End Prostate Cancer, published an interesting article from the New York Times entitled “A  Watch-and-Wait Prostate Cancer Treatment.”  The article focused on the PSA screening and subsequent actions that a man over the age of 70 can take to keep his prostate cancer from developing further and becoming problematic. Subjects such as cryosurgery, diet and nutrition, screenings and biopsies are discussed along with helpful advice from noted urologists.

2) The drug, TAK-700 (Ortoronel) and Phase 3 clinical trials have been described in a blog published on this website on June 3rd, 2011. TAK-700 is an oral, non-steroidal, androgen (e.g. testosterone) synthesis inhibitor.  It is being developed by the Takeda Oncology Company affiliated with Millennium. They are sponsoring safety and efficacy clinical trials in men with metastatic prostate cancer who have not had previous chemotherapy or who have had chemotherapy more than two years earlier for early-stage prostate cancer (elm pc004) or metastatic cancer who have received chemotherapy (elm pc005). The trials are evaluating the safety and efficacy of TAK-700 when combined with prednisone as compared with prednisone alone.  End points of the study are delay in disease progression and increased survival times.  For details, see their website at

3) The November 16th issue of Johns Hopkins Prostate Disorders Health Alerts (link) discusses the attractive option of using cryotherapy as a salvage procedure following failure of external beam radiation and/or brachytherapy to eradicate all the prostate cancer. Cryotherapy could minimize potential damage to the bladder and/or rectum which could occur if surgery or additional radiation therapy were used. See the full article for details.

MDV3100 Extends Life in Men Whose Prostate Cancer Had Failed Hormonal- and Chemotherapies.

Sunset viewing at Placida, FL / bjgabrielsen

Positive Phase 3 clinical trial results for the drug MDV3100 in men whose prostate cancers had progressed after failing hormonal therapy and chemotherapy have recently been reported in a special edition of the Prostate Cancer Foundation Newsletter, November 7th, 2011 (see  Such positive results were observed that the trial was stopped early and the drug provided to men who had been previously receiving the placebo.  MDV3100 was found to increase the median survival time by 4.8 months and provided a 37% reduction in the risk of death when compared to placebo. Some men had more durable remissions while some did not respond. Based on these results, the drug’s developers, Medivation Inc. and Astellas Pharma Inc., plan to submit MDV3100 to the Food and Drug Administration for approval in 2012.  MDV3100 has been under clinical development in advanced prostate cancer patients who have already received chemotherapy with taxotere (docetaxel) as well as those who have not been treated with taxotere.  MDV3100 works by blocking the androgen receptor (which is the engine that drives prostate cancer progression) at three distinct points in the cell-signaling pathway.  The drug blocks testosterone (the fuel that drives the engine) from binding to the androgen receptor (the engine), impedes movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation) and inhibits binding to DNA. MDV3100 has been described in an earlier blog (February 18th, 2011) on this website.

Stopping of a clinical trial and offering the drug to patients taking the placebo had occurred earlier this year with the FDA-approved drug Zytiga (abiraterone acetate). Zytiga affects prostate cancer progression by shutting off the supply of testosterone, the fuel that drives the cancer engine. Using both MDV3100 and Zytiga together seems to be a very logical idea. A Phase 3 trial is already underway in hormone-resistant (refractory) prostate cancer patients who have never received chemotherapy. The results are not yet available but the trend will be to use both drugs earlier in the history of prostate cancer patients. They could possibly be used to potentially cure patients with high-risk cancer who had not yet been treated surgically.

God Sees the Whole Picture Exceedingly and Abundantly; We Don’t.

I often consider my prostate cancer as “my problem.” I am focused on being maintained in a symptom-free condition for as long as possible, or potential treatments as needed and finally focused on not dying of the disease. But God sees my condition from a totally different viewpoint. From my personal perspective, it is often too easy for my trust to flounder and for my spiritual eyes to drift from God and Jesus to my disease. Once my focus shifts away from God, the problem becomes magnified. Such negative thinking can overwhelm faith and extinguish courage. We also tend to see obstacles such as prostate cancer in terms of our own strength and resources rather than God’s. Too often we miss God’s specific plan for us (which is always the best according to Romans 8:28 and Ephesians 2:10) because we view our disease as a problem instead of an opportunity.

God has a master plan for our good and it can even include a disease like prostate cancer. Had my cancer not recurred in 2002, I would not have launched this website (which I pray has been of some use to at least one person). When was the last time someone did something for you in a manner that was “exceedingly abundantly” more than you hoped for?  To me, the word ‘abundantly’ means more than I need or want. ‘Exceedingly’ tells me it goes beyond what I perceive as needing or wanting. But the Bible states in Ephesians 3:20-21, “Now to Him who is able to do exceedingly abundantly beyond all that we ask or think, according to the power that works within us, to Him be the glory ………in Christ Jesus to all generations forever and ever, Amen.” (Ephesians 3:20-21.) God’s ability and love are unlimited. The apostle Paul clearly understood this when he wrote in Philippians 4:13, “I can do all things through Christ who strengthens me.” Everything I need, He will provide in His time. Problems and roadblocks are a way for God to demonstrate His awesome power and for our own faith to grow and mature. When our focus shifts to a Godly perspective, gloom turns to gladness and we experience joy.

God doesn’t always show us the entire picture; often He reveals it little by little. Why? So we will learn to rely on Him daily for all we need and trust Him for tomorrow. This would not be the case if I as an individual saw my entire future in one snapshot. As long as God has the entire picture of my present and eternal life in His view and under His control, I don’t need to see it all. HE SEES IT ALL.

Coming shortly, update on new promising drug, MDV 3100.

South rim, Grand Canyon, Arizona; bj gabrielsen

FDA Grants Fast Track Designation to Radium-223 Chloride (Alpharadin) for the Treatment of Hormone Refractory Prostate Cancer That Has Spread to the Bone.

Hidra, southern Norwegian coast; bjgabrielsen

At the annual American Society of Clinical Oncology (ASCO) meeting in Chicago in June 2011, the Prostate Cancer Foundation September 30th newsletter reported on promising Phase III clinical trial results for radium-223 chloride (alpharadin), an agent specifically being developed for cancer patients with bone metastases. The drug works by emitting small doses of alpha particle radiation that damage the DNA of cancer cells, thereby killing them without harming healthy cells. [It should be noted that in comparison with other radioactive particles, alpha particles are quite heavy and do not penetrate surrounding tissues very far.] The data presented indicated that alpharadin significantly improves overall survival in patients with hormone-resistant prostate cancer that has metastasized to the bone. This conclusion was also cited in a report in the October 4th ZeroHour Newsletter. Thus, alpharadin may be the first drug to improve survival in men with cancer of the prostate that has spread to the bone, a worsening of the disease that occurs in 90 percent of men in the advanced stages of the disease.

Alpharadin was initially discovered by a Norwegian company Algeta ASA and was subsequently exclusively licensed to Bayer HealthCare Pharmaceuticals. On the basis of the results described above, alpharadin has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of castration-resistant (hormone-refractory) prostate cancer in patients with bone metastases. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need, thereby hopefully leading to earlier drug approval and access by patients. Bayer plans to apply for regulatory approval in Europe and the U.S. by the middle of next year.

b) Earliest Known Cases of Prostate Cancer.

North rim of Grand Canyon, Arizona- bj gabrielsen

In an article published in the International Journal of Paleopathology, a research team in Portugal has recently diagnosed the oldest known case of prostate cancer in ancient Egypt and the second oldest documented case in the world. The earliest diagnosis came from a 2,700 year-old skeleton of a Scythian king in Russia. The tumors were detected by performing high-resolution computerized tomography (CT) scans on three Egyptian mummies in which small, 1-2 mm diameter tumors were detected in the pelvis, lumbar spine and upper arm and leg bones. While it has been thought that exposure to carcinogens during the industrial age led to a general increase in cancers, this disease could have been prevalent in ancient peoples as well. This information was adapted from ScienceNOW, an on-line daily news service of the journal Science.

Update on Government Panel Recommendation to Discontinue PSA Screening.

As discussed in this website blog posted on October 15th, a government medical panel, the United States Preventive Services Task Force, recently recommended that routine PSA testing in healthy men under the age of 75 be discontinued unless they have symptoms that are highly suspicious for prostate cancer. The panel claimed that such routine screening did not result in the overall saving of lives but instead led to an increase of  potentially harmful side effects. This controversial recommendation has produced considerable comment. The Johns Hopkins Health Alerts  posted an excellent review of this issue in their October 26th edition. I recommend reading the Johns Hopkins review of the current situation and the government panel’s rationale for their recommendation. Johns Hopkins’ advice was as follows. “Many leading cancer and patient groups and doctors agree that there is harm with PSA screening and the treatment that follows diagnosis. But a more targeted screening approach focusing on those at greatest risk of developing prostate cancer and active surveillance for those who don’t need immediate treatment, could shift the balance of benefit and harm toward benefit. PSA screening is the best test available for the detection of cancer cells in the prostate. Rather than discontinuing use of the only test available to detect the disease early and treat it successfully, efforts should focus on reducing harm.”

In addition, the November 1st edition of the ZeroHour Newsletter from the Project to End Prostate Cancer, cited an article published on October 28th in U.S. News and World Report, disclosing the results of a survey of urologists and internal medicine specialists’ responses to the government recommendation. “Virtually all responding urologists and more than 60 percent of internal-medicine specialists rejected the recent proposal by a high-level government advisory committee to end routine PSA testing.” About 95 percent of the responding urologists felt that doctors should continue to advise men starting at age 50, when testing typically begins, to have PSA screenings as part of a routine physical exam, contrary to the task force’s recommendation. There was however agreement that too many patients are encouraged to seek radical prostatectomy or radiation treatments and too few are informed about “watchful waiting”, in which periodic PSA tests, frequent physical exams, and biopsies are used to track a tumor’s growth and decide when, if ever, to pursue aggressive treatment.