THE "NEW" PROSTATE CANCER INFOLINK

What is described as an open-label, multi-center, single-arm study (the ADRESU trial) has opened in Japan to evaluate the efficacy and safety of periurethral injection of autologous adipose-derived regenerative cells (ADRCs) for the treatment of male stress urinary incontinence resulting from radical prostatectomy (or from transurethral resction of the prostate).

In the information available on ClinicalTrials.gov, this trial is also described as a “Phase III” clinical trial, but The “New” Prostate Cancer InfoLink is doubtful that it would meet Phase III criteria required by European or American regulatory agencies like the U.S. Food and Drug Administration since:

• It is a small trial, enrolling only 45 patients.
• It is neither randomized nor blinded.
• There is no way to determine whether the active treatment is necessarily any better or safer than either a placebo or any other standard of care for the patients.

Having said that, it may well be that the trial is of high enough quality to gain approval of the new type of therapy in Japan, and then the developers could do larger trials to seek approval in Europe and America.

Eligible patients must

• Be 20 or more years of age
• Have had stress incontinence for more than  a year after either
• A radical prostatectomy for localized prostate cancer (currently without relapse/metastasis, and with a PSA level < 0.1 ng/ml) or
• A transurethral prostatectomy or laser prostatectomy for benign prostatic hyperplasia (BPH) and a PSA level l< 4.0 ng/ml
• Have an average  urine leakage volume of > 30 g and < 300 g in a 24-hour pad test

The ability to develop new, effective, and safe forms of treatment for men with long-term urinary incontinence after radical prostatectomy is a priority. While surgical procedures exist that can be very successful in some patients, simpler treatments would be a significant advance in the ease and quality of care available.

The therapy being tested, known as Cytori Cell Therapy™ and developed by the Japanese company Cytori Therapeutics, Inc., has already enrolled and treated its first patient.

Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: cell, Cytori, incontinence, therapy, trial |