Clinical trial · Interventional
Extension to Study of Effects of Pomegranate Extract on Rising PSA Levels After Primary Therapy for Prostate Cancer
A 48-Month Extension to the Randomized, Double-blind, Placebo-Controlled Study of the Effects of Pomegranate Extract on Rising Prostate-Specific Antigen Levels in Men Following Primary Therapy for Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Dietary Supplement | — | UNRESOLVED |
| pomegranate extract | Dietary Supplement | — | UNRESOLVED |
| pomegranate juice | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Dietary Supplement: pomegranate extract
- type
- EXPERIMENTAL
- label
- 2
- interventionNames
- Dietary Supplement: pomegranate juice
- type
- PLACEBO_COMPARATOR
- label
- 3
- interventionNames
- Dietary Supplement: placebo
Primary outcomes (1)
- measure
- The primary outcome variable will be the mean PSA doubling time at the end of 12, 24,36 and 48 months.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
References
Publications (0)
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