Androgen deprivation therapy, heavily-prescribed for men with prostate cancer, may have an unforeseen downside. According to a new study, lack of androgen may make any surviving cancer cells more invasive.
Free Prostate Cancer Symposium on October 20, 2007 — The Methodist Hospital, Houston, Texas. Speakers are physician-scientists from The Methodist Hospital, Baylor College of Medicine and UT. Focus is on the roles of XRT, Robotic and Laparoscopic Surgeries; Hormone Management and Alternatives to Hormone Therapy and treatments in the pipeline such as Vaccines and Gene Therapy. Save the Date!
Edap TMS SA (EDAP) said it is currently conducting clinical investigations in France under an approved clinical trial combining the company’s Ablatherm-HIFU device with chemotherapy using docetaxel.
The study is a primary treatment therapy program for men suffering from clinically localized but aggressive high risk prostate cancer typically classified as stage T2c. The study began in late 2006 and the company expects to enroll up to 30 men, of which more than 10 have already been treated. More details — press release.
In submitting Provenge vaccine for the treatment of advanced prostate cancer for fast-tracked FDA approval despite aborting one clinical trial due to failure to meet the primary endpoint, Dendreon relied on meta-analysis of combined data from two parts of a phase III study, D9901. In fact, after the trials failed to meet their primary endpoint, time to progression, they were analysed twice over. Dr. Eric Small presented meta-analyses of impact on overall survival and prostate cancer specific survival and Dr. Daniel Petrylak presented a further analysis or suvival focused on a subset of patients who, when they progressed on Provenge, took Taxotere.
Danny Goldstein, a doctoral candidate in pharmacy in Israel, has developed a way of combining Taxol with Herceptin monoclonal antibody that overcomes the problem of the toxic emulsion normally required to make Taxol soluable. Goldstein’s nanoemulsion, used to create a Taxol-Herceptin combination and tested in mice, may allow superior, sustained delivery of this therapy to patients with advanced, mestatstic prostate cancer. Clinical trials will begin in about two years. Full story Nanotechnology Improves Chemotherapy-Antibody Combination, June 22.
A link to a 5 hour video recording of the FDA Advisory Committee hearing held March 29 on sipuleucel-T (Provenge) for advanced, androgen independent prostate cancer. The video does not include the vote.
A full written transcript in .pdf including the voting is online at FDA, click here.
A crowd of about 70 people led by prostate cancer advocates marched and rallied in Washington, D.C. on June 4 to call on the FDA to Approve Provenge Now.
Thomas Farrington of Prostate Health Education Network addressed the group.
Raise a Voice organizer Jan Manarite introduced speakers including Tom Farrington and Dr. Mark Moyad.
The petition campaign was organized by malecare.com.
Visit Joel Nowak’s advancedprostatecancer.net blog,
Provenge Advocacy Hits the News
On June 5, campaigners met with FDA director Andrew von Eschenbach.
View ABC-TV video here. See photos of the rally (by brad.wick) and video of Mark Moyad’s speech.
Oncologist Dr. Howard I. Scher has received a death threat for opposing immediate FDA approval of Dendreon’s Provenge therapeutic vaccine for prostate cancer. Another oncologist who opposes approval of Provenge without completion of an ongoing clinical trial, Dr. Maha Hussain, has received unspecified threats.
A team of urologists in Brussels estimate that a third of the men currently diagnosed with prostate cancer in their service could benefit from active surveillance, avoiding loss of quality of life. The Belgian doctors, led by Paul J Van Cangh, MD, are concerned that “widespread opportunistic PSA screening of prostate cancer has resulted in a large proportion of patients aggressively treated for low burden disease.” Reporting on the topic at this year’s annual meeting of the American Urological Association (AUA) in Anaheim California, May 19-24, they say: “Increased concern about overtreatment has led to the development of active surveillance protocols. Here we have reviewed pathological characteristics, disease free survival, and quality of life of patients treated by radical prostatectomy (RP) who might have been elected for active surveillance.”
Data presented today from an ongoing study designed to explore the biologic and clinical activity of cancer immunotherapy sipuleucel-T, or Provenge, in patients with early stage recurrent prostate cancer who have a rising serum prostate specific antigen (PSA) level, but who have not yet developed metastatic disease are not all that impressive. The study showed that sipuleucel-T did not significantly delay the time it took for a patient’s PSA to reach a value of 3 ng/ml, the primary endpoint of the study, but it did show a prolongation in prostate-specific antigen doubling time (PSADT). An “early trend” toward slowing the time to metastatic disease for patients who received sipuleucel-T compared with those who received placebo “did not reach statistical significance.”
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