Nanocurcumin for Prostate Cancer Patients Undergoing Radiotherapy (RT)

Phase 2

• Conditions: Prostate Cancer
• Interventions: Drug: Curcumin; Radiation: RT; Drug: Placebo

• Registration Number: NCT02724618
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

There is a growing body of evidence exploring the role of curcumin as a radioprotector against radiation-induced injury in normal tissues as well as a radiosensitizer in tumor cells. The aim of this study is to determine the efficacy of oral nanocurcumin in prostate cancer patients undergoing radiotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-03-31
• Status Verified: 2017-04
• Primary Completion: 2017-04-15
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-12
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

• Histologically confirmed adenocarcinoma of the prostate
• Candidate for External Beam Radiotherapy
• ECOG performance status 0-2

Exclusion Criteria

• Patients with Metastatic Prostate Cancer
• Patients with Kidney & Liver dysfunction
• Gastrointestinal disorders such as IBD, reflux and peptic ulcers
• Any adverse reaction to curcumin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Curcumin plus RT	RT	120mg/day nanocurcumin during RT course
Placebo plus RT	Placebo	120mg/day placebo of nanocurcumin during RT course
Placebo plus RT	RT	120mg/day placebo of nanocurcumin during RT course
Curcumin plus RT	Curcumin	120mg/day nanocurcumin during RT course

Primary Outcome Measures

Name	Time	Method
Proctitis [assessed using Common terminology criteria for adverse events (CTCAE)]	90 days	Proctitis as assessed using Common terminology criteria for adverse events (CTCAE)

Secondary Outcome Measures

Name	Time	Method
Hematologic Toxicity	90 days	Hematologic Toxicity as assessed by significant reduction in hematologic components
Biochemical progression-free survival (b-PFS)	5-years	b-PFS as assessed using Prostate-Specific Antigen (PSA)
Treatment Response	3 months after treatment termination	Treatment Response as assessed using Magnetic Resonance Imaging techniques
Cystitis [assessed using CTCAE Grading Criteria]	90 days	Cystitis as assessed using CTCAE Grading Criteria

Trial Locations

Locations (1)

Shohada-e-Tajrish Medical Center; 🇮🇷 Tehran, Iran, Islamic Republic of