Overview

This trial is active, not recruiting.

Condition prostate carcinoma
Treatments hydroxychloroquine, laboratory biomarker analysis
Phase phase 0
Sponsor Rutgers, The State University of New Jersey
Collaborator National Cancer Institute (NCI)
Start date July 2012
End date April 2017
Trial size 30 participants
Trial identifier NCT02421575, 0220110278, 121102, NCI-2014-02216, P30CA072720

Summary

This phase 0 trial studies hydroxychloroquine in blocking autophagy in patients with prostate cancer who are undergoing surgery or active surveillance. Autophagy is a process in which cells break down some parts of themselves to stay alive during times of stress, such as starvation. This may allow cancer cells to survive damage from chemotherapy. Hydroxychloroquine may block this process from happening.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive hydroxychloroquine PO QD for 14 days and then undergo prostatectomy.
hydroxychloroquine HCQ
Given PO
laboratory biomarker analysis
Correlative studies
(Experimental)
Patients receive hydroxychloroquine PO TID for 14 days and then undergo prostatectomy.
hydroxychloroquine HCQ
Given PO
laboratory biomarker analysis
Correlative studies
(Experimental)
Patients receive hydroxychloroquine PO QD. Treatment continues until the beginning of local therapy or for up to 1 year.
hydroxychloroquine HCQ
Given PO
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Measure
Change in markers of autophagy in prostate tumor (Group I)
time frame: Baseline to 14 days (time of surgery)
Levels of markers of autophagy in prostate tumor (Group II)
time frame: Up to 1 year

Secondary Outcomes

Measure
Distribution of autophagic activity in prostate cancer tissue
time frame: Up to 1 year
Autophagic activity, assessed by beclin-1 levels
time frame: Up to 1 year
Levels of markers of apoptosis in tumor tissue
time frame: Up to 1 year
Clinical activity, as assessed by PSA levels
time frame: Up to 1 year
Number of CTCs in blood samples
time frame: Up to 1 year

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Signed written informed consent - Have abnormal digital rectal examination, or abnormal prostate specific antigen (> 4.0 ng/ml), or obstructing prostate, or biopsy proven prostate cancer - Scheduled for prostate surgery, i.e. transurethral resection of the prostate (TURP) or prostatectomy - Planned to be treated by active surveillance Exclusion Criteria: - Patients on treatment for rheumatoid arthritis or systemic lupus erythematosus - Patients with psoriasis - Patients receiving any disease-modifying anti-rheumatic drug (DMARD) - Active clinically significant infection requiring antibiotics - Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency - Patients taking other commercially available medications which may theoretically either stimulate or inhibit autophagy, which are calcitriol and chloroquine - Patients taking medications which may lead to interactions with hydroxychloroquine, including penicillamine, telbivudine, botulinum toxin, digoxin, and propafenone - Patients must not have prior visual field changes from prior 4-aminoquinoline compound use - Must not be taking hydroxychloroquine for treatment or prophylaxis of malaria - History of hypersensitivity to 4-aminoquinoline compound

Additional Information

Official title Assessment of the Biological Effect of Autophagic Inhibition With Hydroxychloroquine in Prostate Cancer
Principal investigator Eric Singer, MD
Description PRIMARY OBJECTIVES: I. To determine the effect of different doses of hydroxychloroquine on markers of autophagy in prostate tumor. SECONDARY OBJECTIVES: I. To determine the distribution of autophagic activity within prostate cancer tissue. II. To determine the utility of beclin-1 as a marker of autophagic activity. III. To assess markers of apoptosis in tumor tissue. IV. To perform deep-sequencing on prostate tissue obtained at the time of surgery. V. To assess prostate-specific antigen (PSA) as a biochemical endpoint of clinical activity. VI. To determine the number of circulating tumor cells (CTCs) in pre- and post-treatment blood samples. OUTLINE: Patients are assigned to 1 of 2 groups. GROUP I (PLANNING PROSTATECTOMY): Patients in Group I are randomized to 1 of 2 arms. ARM I: Patients receive hydroxychloroquine orally (PO) once daily (QD) for 14 days and then undergo prostatectomy. ARM II: Patients receive a higher dose of hydroxychloroquine PO thrice daily (TID) for 14 days and then undergo prostatectomy. GROUP II (ACTIVE SURVEILLANCE): Patients receive hydroxychloroquine PO QD. Treatment continues until the beginning of local therapy or for up to 1 year.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey.