Clinical trial · Interventional
Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance
A Randomized, Double-Blind, Placebo-Controlled Trial of Curcumin to Prevent Progression of Biopsy Proven, Low-risk Localized Prostate Cancer Patients Undergoing Active Surveillance
NCT03769766CI-TRIAL-00114696recruitingPhase 3ClinicalTrials.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)
This is a prospective study to determine if the use of curcumin randomized against placebo will reduce cancer progression in patients with prostate cancer undergoing active surveillance.
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 |
|---|---|---|---|
| Curcumin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Curcumin
- description
- * Other names for the supplement: BCM-95 CG (Biocurcumax),Tumeric * Manufacture- DolCas Biotech, LLC. * Classification - type of agent: Supplement * Protocol dose: 500 mg twice
- interventionNames
- Drug: Curcumin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Drug: placebo placebo orally twice a day Other Names: •sugar pill
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- The primary end point is rate of disease progression.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 40-89 years * Biopsy proven, low-risk, localized prostate cancer (minimum of 8 cores) * May have had biopsy within last 12 months * ≤4 separate locations in the prostate involved with cancer. If multiple cores are obtained from same lesion or area than this will count as one location. * Gleason score ≤6 with no Gleason pattern 4 * Clinical stage T1c-T2a/b * Serum PSA ≤15 ng/ml * Life expectancy \> 5 years Exclusion Criteria: * Any previous prostate cancer treatment (radiotherapy, chemotherapy, hormonal therapy, oral glucocorticoids, GnRH analogues, prostatectomy) * Concurrent or previous use within 6 months of screening of any 5α-reductase inhibitor * Use of anabolic steroids or drugs with antiandrogenic properties * Prostate volume \>150 cm³ * Patients who are taking antiplatelet, anticoagulant agents or have a history of a bleeding disorder. Patients taking 81 mg of Aspirin will be allowed to enroll with close observation * History of gastric or duodenal ulcers or untreated hyperacidity syndromes. Patients on stable doses (2 months of therapy) of GERD medication allowed. * Patients who are currently taking Curcumin and are unwilling to stop or plan to take Curcumin during the study * Patients with a history of gallbladder problems or gallstones or biliary obstruction, unless patient had cholecystectomy
References
Publications (0)
Data not yet available
No reference posted for this study.