NCT03769766 Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance
| NCT ID | NCT03769766 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 291 participants |
| Start Date | 2019-03-11 |
| Primary Completion | 2029-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 291 participants in total. It began in 2019-03-11 with a primary completion date of 2029-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Yair Lotan, MD
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT03769766 clinical trial?
This trial is open to male participants only, aged 40 Years or older, up to 89 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03769766 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 291 participants.
Is NCT03769766 currently recruiting?
Yes, NCT03769766 is actively recruiting participants. Contact the research team at Catherine.Robinson@utsouthwestern.edu for enrollment information.
Where is the NCT03769766 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT03769766 clinical trial?
NCT03769766 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Yair Lotan, MD at University of Texas Southwestern Medical Center. The trial plans to enroll 291 participants.
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