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Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance

StatusRecruiting
PhasePhase 3
Started2019-03-11
View on ClinicalTrials.gov ↗

Amendment history

2026-06-11
minor
Study Status, Oversight v19
Re-verified, no change to tracked fields
2025-06-06
minor
Study Status v18
Primary completion date2026-11→2029-11
Completion date2028-11→2030-11
2025-04-04
minor
Study Status, Oversight, Eligibility, Contacts/Locations v17
Eligibility criteria+123 characters
[...] um of 8 cores) May have had biopsy within last 12 months ≤4 coresseparate 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 T1 [...] r drugs with antiandrogenic properties Prostate volume >150 gramscm³ Patients who are taking antiplatelet, anticoagulant agents [...]
2024-12-09
minor
Study Status v16
Re-verified, no change to tracked fields
2023-12-06
minor
Study Status v15
Primary completion date2023-11→2026-11
Completion date2026-11→2028-11
Show 14 earlier versions
2022-12-20
minor
Study Status v14
Primary completion date2022-11→2023-11
2022-09-26
minor
Study Status, Sponsor/Collaborators, Eligibility, Contacts/Locations v13
Eligibility criteria+23 characters
[...] r untreated hyperacidity syndromes. Patients on stable doses (2 months of therapy) of GERD medication allowed. Patients who are currently taki [...] min during the study Patients with a history of gallbladder surgeryproblems or gallstones or biliary obstruction,unless patient had cholecystectomy
Study sitescontacts updated at 1 of 1 site
2022-01-25
minor
Study Status v12
Primary completion date2021-11→2022-11
2021-06-11
minor
Study Status, Eligibility v11
Eligibility criteria-18 characters
[...] of gallbladder surgery or gallstones or biliary obstruction will be excluded,unless patient had cholecystectomy
2021-05-24
minor
Study Status, Eligibility v10
Eligibility criteria+35 characters
[...] f 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 h [...]
2021-03-31
minor
Study Status, Eligibility, Contacts/Locations v9
Eligibility criteria+59 characters
[...] atients with a history of gallbladder surgery or gallstones or biliary obstruction will be excluded, unless patient had cholecystectomy
Study sitescontacts updated at 1 of 1 site
2021-03-20
minor
Study Status v8
Re-verified, no change to tracked fields
2020-03-18
minor
Study Status, Eligibility v7
Eligibility criteriarevised
Inclusion Criteria: Age between 4540-89 years Biopsy proven, low-risk, localized prostate cancer [...]
2020-03-09
minor
Study Status, Eligibility v6
Eligibility criteriarevised
Inclusion Criteria: Age between 45-9989 years Biopsy proven, low-risk, localized prostate cancer (m [...]
2020-02-17
minor
Study Status, Contacts/Locations v5
Re-verified, no change to tracked fields
2019-08-21
minor
Study Status, Eligibility v4
Eligibility criteriarevised
Inclusion Criteria: Age between 45-99 years Biopsy proven, low-risk, localized prostate cancer (minimum of 108 cores) May have had biopsy within last 12 months ≤4 cores i [...] th no Gleason pattern 4 Clinical stage T1c-T2a/b Serum PSA ≤1015 ng/ml Life expectancy > 5 years Exclusion Criteria: Any pre [...] ds or drugs with antiandrogenic properties Prostate volume >80150 grams Patients who are taking antiplatelet, anticoagulant a [...]
2019-03-21
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2019-03-01→confirmed 2019-03-11
Study sites0→1
2019-02-26
minor
Study Status v2
Start date2019-01-30→2019-03-01
2018-12-07
minor
Study Status v1
Re-verified, no change to tracked fields
2018-12-06
minor
Original filing
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.
Trial Details
NCT Number NCT03769766
Lead Sponsor University of Texas Southwestern Medical Center
Conditions Prostate Cancer
Enrollment 291 participants
Start Date 2019-03-11
Primary Completion 2029-11 (estimated)
Study Completion 2030-11 (estimated)
Updated on ClinicalTrials.gov 2026-06-15