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Adjuvant Curcumin for Prostate Cancer

Phase 3

Recruiting

Led By Yair Lotan, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Focally positive surgical margins permitted

Aged 30-80 at time of diagnosis with a life expectancy of >= 3 yrs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial will test whether adding the spice Curcumin to standard cancer treatment can help keep cancer from coming back.

Who is the study for?

Men aged 30-80 with prostate cancer who've had surgery to remove the prostate, no lymph node or metastatic disease, and a life expectancy of at least 3 years. They should not have severe liver, kidney, or bone marrow problems and must not be planning additional hormone or radiation therapy post-surgery.Check my eligibility

What is being tested?

The study is testing if Curcumin can prevent cancer from coming back in patients who've undergone surgery for prostate cancer. Participants will either receive Curcumin or a placebo to see which one helps more in stopping the cancer's return.See study design

What are the potential side effects?

Curcumin may cause digestive issues like upset stomach or diarrhea and has been associated with gallbladder problems. It might also interact with blood thinners causing bleeding risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My surgery showed cancer cells at the edge of the removed tissue.

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I was diagnosed between ages 30-80 and expected to live 3 more years or longer.

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I had surgery to remove my prostate due to cancer.

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My cancer is in an early stage and hasn't spread to lymph nodes or other parts.

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My prostate cancer is at an early stage, not spread widely, with low PSA levels.

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I am able to care for myself and perform daily activities.

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My kidney, liver, and bone marrow are functioning well according to recent tests.

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I am not planning to undergo hormone or radiation therapy after surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Serum prostate specific antigen

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: CurcuminActive Control2 Interventions

Curcumin 500 mg orally twice a day

Group II: sugar pillPlacebo Group2 Interventions

placebo orally twice a day

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,127 Total Patients Enrolled

16 Trials studying Prostate Cancer

1,552 Patients Enrolled for Prostate Cancer

Yair LotanLead Sponsor

yair lotanLead Sponsor

Media Library

Curcumin Clinical Trial Eligibility Overview. Trial Name: NCT02064673 — Phase 3

Prostate Cancer Research Study Groups: Curcumin, sugar pill

Prostate Cancer Clinical Trial 2023: Curcumin Highlights & Side Effects. Trial Name: NCT02064673 — Phase 3

Curcumin 2023 Treatment Timeline for Medical Study. Trial Name: NCT02064673 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many enrollees does this trial have so far?

"The clinical trial is recruiting participants, as reflected on the clinicaltrials.gov site. The posting date was May 1, 2014, and the most recent update was September 26, 2022. The trial is being conducted at 1 site and is looking for 608 patients."

Answered by AI

Are there any patients currently being enrolled in this clinical trial?

"Yes, this information can be found on clinicaltrials.gov. The study was first announced on May 1st, 2014 with the most recent update being on September 26th, 2022."

Answered by AI

How can I get involved with this experiment?

"This study is seeking 608 participants with prostate cancer who are between the ages of 30 and 80. Candidates must meet the following criteria: pT1-pT3pNxMx patients who would not require confirmatory imaging for metastatic disease according to standard NCCN or AUA guidelines, Gleason 6 or 7(T2 disease) and PSA less than 20, Eastern Cooperative Oncology Group(ECOG) status 0-2, focally positive surgical margins are permitted, no plan to receive adjuvant hormone or radiation therapy, 30-80 y/o at time of diagnosis with a"

Answered by AI

Does this experiment only test on elderly patients?

"This particular trial is only for patients aged between 30 and 80. Out of the 2178 clinical trials currently active, 79 are for patients below 18 years old and 1356 are for patients above 65."

Answered by AI

Is it risky to take Curcumin?

"Curcumin has been deemed safe by our team at Power with a score of 3. This is due to Curcumin being in Phase 3 of clinical trials, which suggests that not only is there evidence supporting its efficacy, but also that there have been multiple rounds of data collected to support its safety."

Answered by AI

Are there other instances in which Curcumin has been studied in a clinical setting?

"Curcumin, which is being trialed for a variety of potential applications, is currently being studied in 17 live clinical trials. Of these 17 trials, 3 are in Phase 3. Curcumin clinical trials are being conducted at 21 locations, with the majority in Farmington Hills, Michigan."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy

yair lotan 2014. "Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02064673.

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