Effects of Pomegranate Juice or Extract on Rising PSA Levels in Men Following Primary Therapy for Prostate Cancer

Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate
2. Status post surgery, cryotherapy, or radiation therapy for the primary tumor
3. Documented rising serum PSA, including at least one of the following: absolute level of serum PSA >0.2 ng.mL following surgery; absolute level of serum PSA >1.0 ng/mL following radiation or cryotherapy; absolute level of serum PSA >/= 0.4 ng/mL for patients treated with multiple treatment modalities (e.g., surgery + radiation, radiation + cryotherapy, etc.) For the above PSA criteria, there must be 3 rising serum PSA time points over a minimum of 6 months above the minimum nadir achieved, and the entry serum PSA must be >/= 100% above the maximum nadir achieved
4. (Continued from 3) And must have both: 3 non-zero serum PSA measurements (including baseline) that are above the value reported after surgery, radiation cryotherapy or multiple treatment modalities; interval between seum PSA time points must be > 2 weeks
5. Performance status 0 or 1 on the ECOG scale
6. Minimum estimated life expectancy of 6 months
7. Subject must be eighteen years or older
8. Willingness and ability to sign an informed consent document
9. Agreement with complete abstinence from other commercially available pomegranate products during the course of the study
10. Use of dietary/herbal supplements (e.g., saw palmetto, selenium, etc) are acceptable provided the dose has been stable for at least 2 months prior to screening and the subject agrees not to change/stop during the course of the study

Exclusion Criteria:

1. Significant concomitant medical or psychiatric condition that, in the opinion of the investigator, would make the participant a poor protocol candidate
2. 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 >150 ng/mL at study entry
3. Concomitant or antecedent hormonal therapy for rising serum PSA after initial therapy of prostate cancer
4. Known allergy to pomegranate juice
5. Subjects unable or unwilling to comply with protocol requirements
6. Prior treatment with experimental drugs, high dose steroids, or with any drugs or therapy with the potential to impact prostate cancer or PSA within 6 months prior to the first dose of study product and for the duration of the study
7. Serum PSA > 7.0 ng/mL
8. Serum PSA doubling time </= 3 months or 24 > months
9. Evidence of metastatic disease on physical examination or on CT or bone scan
10. Use of finasteride, dutasteride at any point since primary therapy or during the study
11. Diabetes with a known HbA1c level > 7.0% during the past 3 months. Subjects with diabetes who have not had their HbA1c level measured during the last 3 months will have it tested at visit 1
12. Clinically significant abnormal laboratory value > 2X the upper limit of normal (2XULN)