Extension to Study of Effects of Pomegranate Extract on Rising PSA Levels After Primary Therapy for Prostate Cancer

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

High concentrations of anti-oxidants in pomegranate seeds present a potential strategy to delay clinical prostate cancer progression and prolong the interval from primary treatment failure to hormonal ablation. This is a 48 month extension to the double-blind GUP-0205-1 study, to compare the effects of daily consumption of pomegranate liquid extract versus placebo on the absolute prostate-specific antigen (PSA) doubling time at the end of 12, 24, 36 and 48 months in male subjects who rolled-over from the GUP-0205-1 study.

Key facts

Study ID

NCT00732043

Run by

Roll International Corporation

People needed

200

Starts

2007-12-01

Expected to finish

2015-01-01

Last updated by the study team

2012-03-16

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• No evidence of disease progression while on any of the three GUP-0205 study products (disease progression defined as > 100% increase in serum PSA [with a minimum value of 1.0 ng/mL]).
• Willingness and ability to sign an informed consent document.
• Agreement with complete abstinence from other commercially available pomegranate products during the course of the study.
• Use of dietary/herbal supplements (e.g., saw palmetto, selenium, etc) is acceptable provided the dose has been stable during the course of the GUP-0205- 1 study.

You may not qualify if…

• Significant concomitant medical or psychiatric condition that, in the opinion of the Principal Investigator, would put the subject at risk or compromise the protocol.
• Hormonal therapy, with the exception of neoadjuvant androgen deprivation therapy (ADT) prior to or concurrent with primary therapy. Subjects who underwent neoadjuvant ADT cannot have a serum testosterone of ≤150 ng/mL at study entry.
• Concomitant or antecedent hormonal therapy for rising serum PSA after initial therapy of prostate cancer.
• Subjects unable or unwilling to comply with protocol requirements.
• Prior treatment with experimental drugs, high dose steroids, or with any other cancer treatment within 4 weeks prior to the first dose of study product and for the duration of the study.
• Serum PSA >7.0 ng/mL (assessed at termination of the double-blind study; at any PSA level, the subject will be excluded if determined by the Principal Investigator that the subject's continued participation would not be in their best interest).
• Serum PSA doubling time <13 weeks (assessed at termination of the double-blind study).
• Evidence of metastatic disease on physical examination or on CT or bone scan.
• Use of finasteride, dutasteride at any point since primary therapy or during the study.
• Clinically significant abnormal laboratory value greater than 2 times the upper limit of normal (>2XULN).

Where it is running

• UCLA School of Medicine — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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