Phase 2 study of pomegranate extract for men with rising PSA following initial therapy for localized PCa
Monday, 25 June 2012- Pomegranate juice has been associated with PSA doubling time (PSADT) elongation in a single-arm phase II trial. C. J. Paller and colleagues conducted a study to assess biological activity of two doses of pomegranate extract (POMx) in men with recurrent prostate cancer, using changes in PSADT as the primary outcome.
This randomized, multi-center, double-blind phase II, dose-exploring trial randomized men with a rising PSA and without metastases to receive 1 or 3 g of POMx, stratified by baseline PSADT and Gleason score.
Patients (104) were enrolled and treated for up to 18 months. The intent-to-treat (ITT) population was 96% white, with median age 74.5 years and median Gleason score 7. This study was designed to detect a 6-month on-study increase in PSADT from baseline in each arm.
Overall, median PSADT in the ITT population lengthened from 11.9 months at baseline to 18.5 months after treatment (P<0.001). PSADT lengthened in the low-dose group from 11.9 to 18.8 months and 12.2 to 17.5 months in the high-dose group, with no significant difference between dose groups (P=0.554). PSADT increases >100% of baseline were observed in 43% of patients.
Declining PSA levels were observed in 13 patients (13%). In all, 42% of patients discontinued treatment before meeting the protocol-definition of PSA progression, or 18 months, primarily due to a rising PSA. No significant changes occurred in testosterone. Although no clinically significant toxicities were seen, diarrhea was seen in 1.9% and 13.5% of patients in the 1- and 3-g dose groups, respectively.
“POMx treatment was associated with 6 month increases in PSADT in both treatment arms without adverse effects. The significance of this on-study slowing of PSADT remains unclear, reinforcing the need for placebo-controlled studies in this patient population,” the authors wrote.
Source: C, J.Paller, et al., “A randomized phase II study of pomegranate extract for men with rising PSA following initial therapy for localized prostate cancer,” Cancer and Prostatic Diseases , (12 June 2012) | doi:10.1038/pcan.2012.20