Prostate CancerPhase 3NCT02064673
Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy
A Phase 3 study testing Curcumin in people with Prostate Cancer, run by yair lotan at 1 site in United States.
Trial summary
This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival. Read more about this study
- Who is it for?
- Ages 30 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Status post radical prostatectomy for histologically confirmed adenocarcinoma of the prostate
- pathologically confirmed T1-T3 disease
- no sign of lymph node or metastatic disease
- pT1-pT3pNxMx patients in whom standard NCCN or AUA guidelines would suggest are at low risk for pelvic lymph node or metastatic disease and who would not require confirmatory imaging for metastatic disease. This includes patients with Gleason 6 or 7(T2 disease) and PSA less than 20.
- Eastern Cooperative Oncology Group(ECOG) status 0-2
- adequate renal and liver function as well as bone marrow reserve (measured serum creatinine <2mg/dl, bilirubin ≤ 1.5 mg/dl, ANC ≥ 1.5 x 10 (3) uL, platelets ≥ 50 x K/uLL, and hemoglobin ≥ 10 g/dL)
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- 30-80 y/o at time of diagnosis with a life expectancy of >= 3 yrs
- focally positive surgical margins are permitted
- no plan to receive adjuvant hormone or radiation therapy
- PSA at the time of enrollment must be undetectable
- life expectancy of 3 years
Who cannot join
- must not have exceeded 3 months from time of surgery to enrollment into study
- T3b or T4 or node positive disease
- macroscopic residual disease after surgery
- hormone therapy before surgery
- history of gallbladder problems or gallstones, or biliary obstruction, unless patient had cholecystectomy
- radiation therapy as primary treatment after surgery
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- INR value greater than 1.5
- AST/ALT are equal or greater than 2 times the upper limit of normal
- antiplatelet or anticoagulant agents- patients taking 81mg of Aspirin will be allowed with close observation
- history of gastric or duodenal ulcers or untreated hyperacidity syndromes
- patients who are currently taking curcumin and are unwilling to stop or plan to take curcumin during the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Maricruz Ibarra, 214-645-8788, maricruz.ibarra@utsouthwestern.edu
Jessica Williams, 214-648-9195, jessica.williams2@utsouthwestern.edu
About this study
Official title: Randomized Trial of Adjuvant Curcumin After Prostatectomy
This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival.
Read the detailed description
This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival in patients after radical prostatectomy compared to placebo
- Conditions
- Prostate Cancer
- Being tested
- Curcumin, placebo
- Keywords
- prostate cancer, radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Also called Bio-Curcumin(BCM-95CG), Tumeric
Curcumin or placebo 500mg by mouth twice a day for 6 months
placeboDrug
Also called sugar pill
placebo orally twice a day
| Study group | Role | What they receive |
|---|---|---|
| Curcumin | Active comparator | Curcumin 500 mg orally twice a day Receives: Drug: Curcumin; Drug: placebo |
| sugar pill | Placebo comparator | placebo orally twice a day Receives: Drug: Curcumin; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum prostate specific antigen
Recurrence free survival defined as a total serum prostate specific antigen of <0.2ng/ml.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- yair lotan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yair lotan, University of Texas Southwestern Medical Center
- Investigators
- Yair Lotan, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064673
- Sponsor's protocol ID
- STU 042013-080
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2014
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Adjuvant Curcumin After Prostatectomy
- ClinicalTrials.gov ID
- NCT02064673
- Acronym / sponsor ID
- STU 042013-080
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, radical prostatectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- yair lotanUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival.
Detailed description
This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival in patients after radical prostatectomy compared to placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcumin | Active comparator | Drug: Curcumin, Drug: placeboCurcumin 500 mg orally twice a day |
| sugar pill | Placebo comparator | Drug: Curcumin, Drug: placeboplacebo orally twice a day |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Status post radical prostatectomy for histologically confirmed adenocarcinoma of the prostate
- pathologically confirmed T1-T3 disease
- no sign of lymph node or metastatic disease
- pT1-pT3pNxMx patients in whom standard NCCN or AUA guidelines would suggest are at low risk for pelvic lymph node or metastatic disease and who would not require confirmatory imaging for metastatic disease. This includes patients with Gleason 6 or 7(T2 disease) and PSA less than 20.
- Eastern Cooperative Oncology Group(ECOG) status 0-2
Key exclusion criteria (11 listed)
- must not have exceeded 3 months from time of surgery to enrollment into study
- T3b or T4 or node positive disease
- macroscopic residual disease after surgery
- hormone therapy before surgery
- history of gallbladder problems or gallstones, or biliary obstruction, unless patient had cholecystectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminAlso: Bio-Curcumin(BCM-95CG), TumericCurcumin or placebo 500mg by mouth twice a day for 6 months | Drug | Curcumin, sugar pill |
| placeboAlso: sugar pillplacebo orally twice a day | Drug | Curcumin, sugar pill |
Primary outcome
Serum prostate specific antigen
Time frame: 3 years
Recurrence free survival defined as a total serum prostate specific antigen of <0.2ng/ml.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yair Lotan, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Curcumin in people with Prostate Cancer, run by yair lotan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corey Nixon (214-645-8787, Corey.Nixon@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum prostate specific antigen (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.