Hydroxychloroquine in Blocking Autophagy in Patients With Prostate Cancer Undergoing Surgery or Active Surveillance

• Status: Terminated
• Trial end date: 2016-02-26
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI); Rutgers Cancer Institute of New Jersey
• Treatments: Hydroxychloroquine

Criteria

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