Hydroxychloroquine in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: hydroxychloroquine

• Registration Number: NCT00726596
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

This phase II trial studies how well hydroxychloroquine works in treating patients with previously treated prostate cancer. Autophagy destroys proteins and other substances in cells and may be used by prostate cancer cells to survive. Hydroxychloroquine, which blocks autophagy, may slow the growth of and possibly kill prostate cancer cells.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-31
• Study First Submitted QC: 2008-07-31
• Study Start: 2008-08
• Study First Posted: 2008-08-01
• Primary Completion: 2014-02
• Results First Submitted: 2017-03-31
• Study Completion: 2018-01
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-08
• Last Update Submitted: 2022-06-08
• Results First Posted: 2022-06-16
• Last Update Posted: 2022-06-16

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hydroxychloroquine	hydroxychloroquine	Hydroxychloroquine - 400 mg (cohort A) Hydroxychloroquine - 600 mg (cohort B)

Primary Outcome Measures

Name	Time	Method
Prostate-specific Antigen (PSA) Response	6 years	PSA response will be defined as a change in slope of at least 25%, when log (PSA) is plotted vs. time

Secondary Outcome Measures

Name	Time	Method
Effect on Peripheral Blood Mononuclear Cell (PBMC) LC3 Expression by the Use of Hydroxychloroquine	6 years	A change of at least 25% from baseline will be considered to be a significant response
Effect on PBMC Autophagic Vesicle Formation by the Use of Hydroxychloroquine	6 years
Expression of Beclin-1 in a Population of Patients Having Undergone Local Treatment With Prostatectomy	6 years
Feasibility and Safety of Administering Hydroxychloroquine in This Population of Patients. Rate of Adverse Events	6 years	Rate of adverse events were captured utilizing the CTCAE version3.0.

Trial Locations

Locations (5)

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

Carol G. Simon Cancer Center at Morristown Memorial Hospital; 🇺🇸 Morristown, New Jersey, United States

Cancer Institute of New Jersey at Hamilton; 🇺🇸 Hamilton, New Jersey, United States

Cooper University Hospital Cancer Institute; 🇺🇸 Voorhees, New Jersey, United States

Overlook Hospital; 🇺🇸 Summit, New Jersey, United States