Prostate cancer diets and the use of supplements have continued to be an issue faced by men fighting advanced prostate cancer. Different products seem to fall in and out of vogue; unfortunately we usually have little actual hard data on the real value of any of these products.
The use of pomegranate with the goal of extending PSA doubling time (PSADT) (the amount of time it takes for the PSA score to double in size…. 2 to 4; 4 to 8 etc.) is one of these issues that has been debated over the last four to five years. The initial, small study of the use of pomegranate was performed at UCLA. This study confirmed that pomegranate did extend the PSADT, but many individuals discounted the study because of its very small size and because it was funded by POM Wonderful, one of the major manufactures of pomegranate juice and extract.
At today’s Genitourinary Cancers Symposium, Carducci et al. will report data from a randomized, multi-center, double-blind, Phase II clinical trial that compared two different doses of POMx capsules in men with a rising PSA after primary treatment who wished to delay starting androgen deprivation therapy (ADT).
The trial randomized men who had a rising PSA but no metastases. The men received either high-dose (3 mg/d) or low-dose (1 mg/d) of POMx. The men were stratified based on their baseline PSADT values and their Gleason scores; however, there were no restrictions on PSADT and no upper limit PSA scores. The end points were until disease progression or for 18 months. PSA scores were recorded every 3 months. This study was designed to detect a 6-month increase in PSADT from baseline.
The results of the study, as presented in the study abstract, are as follows:
• 104 men were enrolled and treated for up to 6, 12, and 18 months (92, 70, and 36 percent of men respectively).
• The men were 96 percent white, had a median age of 74.5 years, and a median Gleason score of 7.
• The average (median) PSADT was 11.9 months at baseline with a range of 1.6 to 54.6 months compared to 18.5 months
with a range of 2 to 1,523 months after treatment (p < 0.001).• There was no significant treatment difference in effect on PSADT between the two dose groups (p = 0.920).• Declining PSA levels were observed in 13/104 men (13 percent) during the study.• There were no significant changes in serum testosterone levels in either group.• Mild to moderate diarrhea was seen in 8/104 men (7.7 percent).Carducci and his colleagues conclude that, “POMx treatment significantly increased the PSADT by over 6 months in both treatment arms, with no effect on testosterone.”This study concludes that pomegranate extract has some clinically positive effect on the PSADT. It also shows that the lower dosage of POMx is equally as effective as the higher dosagePOM Wonderful recently was prevented by the FDA from promoting the supposed positive effects of POMx on PSADT because of the lack of clinical evidence. This trial will not change the FDA’s perspective.The only supplement that I have personally used and continue to use is POMx. This study does support my non-scientific belief that POMx does extend PSADT, at least in men with a rising PSA but no indication of bone metastasis.I also wish to add that I still remain concerned that not all supplements are created equal. The FDA does not regulate the manufacturing process of supplements and often there is little or no quality control by the manufacturer. I do believe that POMx does make a legitimate product and does have reasonable quality controls in place.Joel T. Nowak, M.A., M.S.W.