Clinical trial · Interventional
Pomegranate Extract in Treating Patients With Rising Prostate-Specific Antigen Levels After Surgery or Radiation Therapy for Localized Prostate Cancer
A Randomized, Double-Blind, Placebo-Controlled Study of The Effects of Pomegranate Extract On Rising Prostate-Specific Antigen Levels In Men Following Primary Therapy
- 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 extract may keep prostate cancer from growing in patients with rising prostate-specific antigen (PSA) levels after surgery or radiation therapy for localized prostate cancer. PURPOSE: This randomized trial is studying how well pomegranate extract works in treating patients with rising PSA levels after surgery or radiation therapy for localized 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Other | — | UNRESOLVED |
| pomegranate juice | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral pomegranate extract daily.
- interventionNames
- Dietary Supplement: pomegranate juice
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive oral placebo daily.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Objective response
- timeFrame
- 12 months
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Must have completed prior surgery, cryotherapy, or radiotherapy for the primary tumor
* Documented rising prostate-specific antigen (PSA)
* Absolute level of PSA \> 0.2 ng/mL after surgery
* Absolute level of PSA \> 1.0 ng/mL after radiation or cryotherapy
* Absolute level of PSA ≥ 0.4 ng/mL after multiple treatment modalities (e.g., surgery with radiotherapy or radiotherapy with cryotherapy)
* PSA must be ≥ 100% above best nadir achieved
* PSA doubling time \> 3 months or ≤ 24 months
* Patients must have ≥ 3 rising PSA time points above the minimum nadir achieved over ≥ 6 months
* The interval between PSA time points must be \> 2 weeks
* PSA ≤ 7.0 ng/mL
* Patients who underwent radical prostatectomy and never achieved undetectable serum PSA after surgery are not eligible
* Gleason score ≤ 7
* No histologically positive lymph nodes
* No evidence of metastatic disease by physical examination, CT scan, or bone scan
PATIENT CHARACTERISTICS:
* Life expectancy ≥ 6 months
* ECOG performance status 0 or 1
* No significant concomitant medical or psychiatric conditions that would limit study compliance
* No known allergies to pomegranate extract
* No known diabetes with hemoglobin A\_1c level \> 7.0% in the past 3 months
* Diabetic patients entering study who have not had hemoglobin A\_1c level measured in the past 3 months must have levels measured at study initiation
* No clinically abnormal laboratory values \> 2 times the upper limit of normal
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 4 weeks since prior and no concurrent experimental drugs, high-dose steroids, or other cancer treatment
* No hormonal therapy, with the exception of neoadjuvant androgen-deprivation therapy (ADT), prior to or concurrent with primary therapy
* Patients who received prior neoadjuvant ADT must have serum testosterone ≥ 150 ng/dL
* No prior or concurrent hormonal therapy for rising PSA after primary therapy for prostate cancer
* No finasteride or dutasteride at any time point after primary therapy and during study therapy
* No other concurrent commercial pomegranate products
* No other concurrent systemic or local therapy for prostate cancer
* Concurrent dietary/herbal supplements (e.g., saw palmetto or selenium) allowed provided dose has been stable for ≥ 2 months prior to study entry and there are no plans to change or stop the supplements during study therapyReferences
Publications (0)
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