Clinical trial · Interventional
Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer
Phase II Study Evaluating Pomegranate Juice In Patients With Recurrent Adenocarcinoma Of The Prostate
NCT00060086CI-TRIAL-00052103completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Pomegranate juice may contain substances that decrease or slow the rise of prostate-specific antigen (PSA) levels and may be effective in delaying or preventing recurrent prostate cancer. PURPOSE: This phase II trial is studying how well pomegranate juice works in decreasing or slowing the rise of PSA levels in patients who have undergone radiation therapy or surgery for prostate cancer.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pomegranate juice | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pomegranate Juice
- description
- Subjects are given oral pomegranate juice once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Dietary Supplement: pomegranate juice
Primary outcomes (1)
- measure
- Clinical efficacy, in terms of overall response rate, measured by serum prostate-specific antigen (PSA) levels every 3 months
- timeFrame
- Evaluated every 3 months for 18 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * Must have undergone prior surgery or radiotherapy for the primary tumor * Documented rising prostate-specific antigen (PSA) level, defined by the following criteria: * Absolute level of PSA at least 0.2 ng/mL but less than 5.0 ng/mL * Rising PSA level must be confirmed at least 1 week later * Adequate PSA time points to calculate a PSA doubling time * Gleason score no greater than 7 * Age 18 and over * Performance status ECOG 0-1 * Life expectancy at least 6 months * No other malignancy within the past 5 years except nonmelanoma skin cancer * No other serious concurrent systemic medical disorders that would preclude study compliance * No known allergy to pomegranate juice * More than 4 weeks since prior participation in another experimental study Exclusion Criteria: * nodal involvement * evidence of metastatic disease * prior hormonal therapy * concurrent hormonal therapy for rising PSA levels after initial therapy for prostate cancer * concurrent participation in another experimental study * other concurrent systemic or local therapy for prostate cancer * initiation or discontinuation of any new nutritional or dietary supplements during study participation
References
Publications (0)
Data not yet available
No reference posted for this study.