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

September 15, 2023 updated by: yair lotan

Randomized Trial of Adjuvant Curcumin After Prostatectomy

This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

608

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Curcumin
Curcumin 500 mg orally twice a day
Drug: Curcumin
Curcumin or placebo 500mg by mouth twice a day for 6 months
Other Names:
  • Tumeric
  • Bio-Curcumin(BCM-95CG)
Drug: placebo
placebo orally twice a day
Other Names:
  • sugar pill
Placebo Comparator: sugar pill
placebo orally twice a day
Drug: Curcumin
Curcumin or placebo 500mg by mouth twice a day for 6 months
Other Names:
  • Tumeric
  • Bio-Curcumin(BCM-95CG)
Drug: placebo
placebo orally twice a day
Other Names:
  • sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum prostate specific antigen
Time Frame: 3 years
Recurrence free survival defined as a total serum prostate specific antigen of <0.2ng/ml.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

yair lotan

Investigators

  • Principal Investigator: Yair Lotan, MD, UT Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimated)

February 17, 2014

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 042013-080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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