Category: Treatment Information

Surgery (radical prostatectomy) is one option for treating prostate cancer. Personally, since I was in my mid-50’s when prostate cancer was detected, I opted for this route. The two major risks posed by surgery and other treatments are incontinence and impotence.  The area surrounding the prostate gland is densely composed of small blood vessels and nerves which control urinary function and erections. The presence of numerous small blood vessels in the area surrounding the prostate make the surgical field a bloody one, hence the chances of severing an essential nerve(s) are increased. In the 1980’s, Dr. Patrick Walsh of Johns Hopkins Hospital in Baltimore, Maryland developed a surgical technique wherein sensitive nerves could be spared to a large degree, hence the term “nerve-sparing” prostatectomy. This technique is described in numerous on-line websites including the September 14th issue of the  Johns Hopkins Health Alerts. If you are considering having a radical prostatectomy either robotically or via the traditional surgical route, I highly suggest you seek out an experienced surgeon who has been specifically trained in the nerve-sparing technique and has performed many often thousands of these procedures successfully. One should also inquire about their success rates for maintaining erections and minimizing incontinence. From personal experience, I have found that an individual is “never quite the same” after most forms of treatment. Hence limiting any undesirable side effects is of maximum importance. While surgeons proficient in this technique are not limited to Johns Hopkins physicians, I have found numerous sites of interest by searching the internet using the term “nerve sparing prostatectomy, Johns Hopkins.”  or “nerve-sparing technique, prostate cancer.” There are also a series of videos depicting the surgery itself which illustrate the challenges and surgical prowess necessary to preserve urinary and erection-maintaining functions. Seeking the proper surgeon is the key to success. In my own case, upon my diagnosis in 1995, my first impulse was to contact Dr. Patrick Walsh at Johns Hopkins but when I sought God’s advice, He led me to one of Dr. Walsh’s colleagues, Dr. Jacek Mostwin, currently Professor  of Urology at John Hopkins Medicine. I can personally recommend him most highly. There are however many other skilled and experienced surgeons at fine hospitals and university centers. The reader is urged to seek them out and ask pertinent questions. God often treats and heals our infirmities through gifted physicians, a fact to which I can testify.

On May 15th, 2013, the U.S. Food and Drug Administration approved Xofigo (previously known as Alpharadin) for use in men with treatment-resistant prostate cancer that had metastasized to bones but not to other organs. Xofigo, administered by injection, will be marketed by Bayer Healthcare Pharmaceuticals who developed the therapy jointly with Algeta, ASA, a Norwegian pharmaceutical company. The drug works by delivering radioactive alpha particles directly to prostate cancer cells that have formed tumors in bone. The radioactive alpha particles from radium-223 dichloride are relatively “heavy” and therefore do not penetrate very far in the body thus limiting the effect of the drug to about a 10-cell radius thereby limiting its toxicity. The drug binds with minerals in the bone to deliver radiation directly to the bones limiting damage to surrounding tissues.  In Phase III clinical trials, men given Xofigo experienced a six-month longer timeframe to first complications (fractures or spinal cord compression) occurring as a result of bone tumors, a survival advantage of about 3 months and a higher quality of life. Xofigo also produced a 50% reduction in the risk of spinal cord compression caused by tumors—a complication that can result in paralysis, severe pain, and other loss of functions.

Further information was reported in the May 31st, 2013 issue of the Prostate Cancer Foundation NewsPulse, and a special May 15th bulletin from the Prostate Cancer Research Institute (PCRI).  Additional information including a video from Duke University describing the potential role of Xofigo in the overall sequence of prostate cancer treatment was published in the June 28th, 2013 issue of the PCF NewsPulse. Patients who are interested in finding out where and when Xofigo will be available can call 1-855-696-3446 (1-855-6Xofigo) or visit the website http://xofigo-us.com/index.php.

New information has recently been published updating early clinical trials results for two new promising prostate cancer drugs, galeterone (TOK-011 from Tokai Pharmaceuticals) and tasquinimod (TASQ, from Active Biotech and Ispen).  Both drugs have been described in the December 20th, 2012 issue of the Prostate Cancer Foundation NewsPulse.

Galeterone: Resistance to therapy is a growing concern in treating cancer as cancer cells mutate to avoid the effects of a given therapy. This is a major problem in androgen-deprivation (ADT) prostate cancer treatment (hormone therapy) when men become resistant (refractory) and testosterone levels rise thus fueling the proliferation of cancer cells. Galeterone, an oral drug also known as TOK-011, is unique in that it is the first and only single-agent therapeutic that combines three distinct approaches to attack prostate cancer and which thereby may help to prevent resistance to ADT. Galeterone’s development and review has received a “fast-track designation” by the U.S. Food and Drug Administration.  Androgen is mainly produced in the testicles (90%) and to a lesser degree by the adrenal glands and even the prostate tumor itself. The male androgen testosterone fuels prostate cancer and triple-action galeterone thwarts prostate cancer cell proliferation by targeting the primary driver of treatment-resistance disease—androgen receptor signaling—in various ways. Galeterone works by blocking testosterone synthesis (specifically by blocking the enzyme CYP17 lyase), blocking testosterone’s ability to bind to its androgen receptor (the prostate cell molecule that responds to the androgen) and finally, by limiting overall androgen receptor levels in the body. A Phase I dose-finding study in 49 chemotherapy-naïve patients produced PSA reductions of greater than 50 percent (50%) in 11 patients (or 22%). Another 26 percent of patients had PSA declines ranging between 30 to 50 percent. Galeterone is now entering a Phase II trial in which Tokai plans to enroll 196 patients, the first of whom has already begun treatment. This trial will use a slightly reformulated version of galeterone that has improvements in its uptake and absorption in the body. In addition, the Phase II trial will not only include men who are chemotherapy-naïve, but also men whose disease has progressed while taking Zytiga (abiraterone acetate), another androgen-inhibiting drug. All patients will be evaluated to determine galeterone’s effects upon PSA levels and their overall safety profiles.  An interesting article about how galeterone was co-developed was published in the Baltimore Sun in September, 2014.

Tasquinimod: Tasquinimod, or TASQ (ABR-215050), is an oral experimental treatment for men with metastatic, treatment-resistant prostate cancer. Chemically, TASQ is a quinoline-3-carboxamide with three-pronged immunomodulatory (activates the body’s immune system to fight cancer), anti-angiogenic (prevents the formation of new blood vessels to feed tumor cells) and anti-metastatic (inhibiting tumor growth) activity. Specifically, TASQ modulates the expression of thrombospondin-1 in human prostate tumors.  After completing Phase I and II clinical trials, Active Biotech and Ispen, the drug’s developers, announced successful enrollment of 1,200 patients in 250 clinics for a global, randomized, double-blind, placebo-controlled Phase III clinical trial evaluating TASQ in men with metastatic, hormone-refractory prostate cancer. The end points of the Phase III study will be progression-free (PFS) and overall survival. Dr. Andrew Armstrong, principal investigator from the Duke University Medical Center, describes the Phase II results as published in the Journal of Clinical Oncology in September, 2011. They showed a median overall survival benefit of three months (33.4 vs. 30.4 months) in favor of TASQ versus placebo. In patients with bone metastases, median overall survival was 34.2 versus 27.1 months. Six month progression-free proportion of patients for TASQ and placebo treatment groups were 69% and 37%, respectively with a median progression-free survival of 7.6 vs. 3.3 months. TASQ treatment also had an effect on biomarkers relevant for prostate cancer progression and was generally well tolerated. In the Phase III clinical trial, researchers will further investigate the drugs overall efficacy, with an ultimate goal of receiving approval from the Food and Drug Administration for the treatment of men with metastatic castrate-resistant disease (CRPC). Phase I and II data show that tasquinimod’s long term safety is acceptable according to Dr. Armstrong. “Tasquinimod may therefore be a suitable therapy to evaluate at an early stage in management of CRPC, either as monotherapy or in combination with other effective agents for prostate cancer, as it does not jeopardize the patient’s chances to receive additional treatment.” For additional information on TASQ and its clinical trials, see the Drugs.com and Active Biotech websites.  The web addresses are: http://www.drugs.com/clinical_trials/active-biotech-ipsen-report-tasquinimod-tasq-phase-ii-long-term-safety-data-27th-european-13084.html; and http://www.activebiotech.com/press-releases?pressurl=http://cws.huginonline.com/A/1002/PR/201212/1663501.xml.