Prostate Cancer - Effects of pomegranate juice or extract or placebo on PSA rising after primary treatment

	UROLOGY MAIN SITE	GEN. ADULT UROLOGY	UROLOGIC ONCOLOGY	MALE UROLOGY	TRANSPLANT PROGRAM
	PELVIC MEDICINE, INCONTINENCE & RECONST. SURGERY		PEDIATRIC UROLOGY	MIN. INVASIVE SURGERY

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Clinical Trial Details

Trial Information

Trial:

Prostate Cancer - Effects of pomegranate juice or extract or placebo on PSA rising after primary treatment

Principal Investigator:	Allan Pantuck, MD, MS, FACS
Co-Investigator(s):	Jean B. deKernion, MD; Arie Belldegrun, MD; Mark S. Litwin, MD, MPH; Jacob Rajfer, MD; Robert E. Reiter, MD;

This trial is currently accepting new patient applications. (Apply)

Objective

A Randomized, Double-Blind, Placebo-Controlled Study of The Effects of Pomegranate Juice or Extract On Rising Prostate-Specific Antigen Levels in Men Following Primary Therapy for Prostate Cancer (Protocol GUP-0205-1; Amendments dated: October 28, 2005 and December 5 2005) IRB # 05-07-059-01

Patient Eligibility

Inclusion Criteria

1. Histologically confirmed adenocarcinoma of the prostate.

2. Gleason score of 7 or less

3. Status post surgery, cryotherapy, or radiation therapy for the primary tumor.

4. No evidence of metastatic disease.

5. Documented rising PSA, including at least one of the following:

a. Absolute level of PSA >0.2 ng/mL following surgery.

b. Absolute level of PSA >1.0 ng/mL following radiation or cryotherapy

c. Absolute level of PSA =0.4 ng/mL for patients treated with multiple treatment modalities (e.g., surgery+radiation, radiation+cryotherapy, etc.) with 3 rising PSA time points over a minimum of 6 months above the minimum nadir achieved and entry PSA must be =100% above best nadir achieved.

d. And must have both:

------Minimum of 3 rising PSA time points over a minimum of 6 months to calculate a PSA doubling time for study entry.

------Interval between PSA time points must be greater than 2 weeks.

Hormonal therapy, with the exception of neoadjuvant androgen deprivation therapy (ADT) prior to or concurrent with primary therapy. Subjects who underwent neoadjuvant ADT must have a serum testosterone of greater than or equal to 150 ng/mL at study entry.

For More Information

For additional information on inclusion and exclusion criteria and whether or not you may be a candidate to participate in a trial, call Nazy Zomorodian, Director for the Clinical Trials Office at (310) 825-5538.