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

NCT ID: NCT00726596

Last Updated: 2022-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2018-01-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hydroxychloroquine

Hydroxychloroquine - 400 mg (cohort A) Hydroxychloroquine - 600 mg (cohort B)

Group Type: EXPERIMENTAL

hydroxychloroquine

Intervention Type: DRUG

Hydroxychloroquine will be taken at a dose of 200 mg twice per day in the first 27 patients (cohort A). Once cohort A completed, the dose of hydroxychloroquine will then be increased to 600mg per day (200mg three times per day)(cohort B).

Interventions

hydroxychloroquine

Hydroxychloroquine will be taken at a dose of 200 mg twice per day in the first 27 patients (cohort A). Once cohort A completed, the dose of hydroxychloroquine will then be increased to 600mg per day (200mg three times per day)(cohort B).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically proven stage D0 prostate cancer (i.e., tumor originally diagnosed as being limited to the prostate) or D1 prostate cancer (metastatic to regional lymph nodes) and have a rising PSA value after definitive local therapy.
• Must have undergone local treatment via prostatectomy or radiation therapy.
• Must have PSA progression after local treatment:

1. PSA values for patients after surgery must be > 0.2 ng/mL, determined by two measurements, at least 1 month apart and at least 6 months after prostatectomy

2. PSA values for patients after radiation must be ≥ 2.0 ng/ml greater than the nadir achieved after radiation, determined by two measurements at 1 month apart and at least 6 months after the radiation treatment is completed. (Patients who received adjuvant or salvage radiation after prostatectomy must have PSA of >0.2)

3. The first two PSA values (in 5.1.3a and 5.1.3b), along with a third (study baseline) value must all be rising (i.e., there must be an overall rising trajectory, such that the third value cannot be lower than the first value).

• Baseline bone scan and CT abdomen/pelvis demonstrating no metastatic disease.
• Age ≥ 18 years
• Estimated life expectancy of at least 6 months.
• ECOG performance status < 2. (see Appendix B)
• A WBC > 3500/μl, ANC >1500/μl, hemoglobin > 10 g/dl, and platelet count >100,000/μl are required.
• Adequate renal function (serum creatinine < 1.5 mg/dL or creatinine clearance > 50 ml/min).
• Total bilirubin must be within 1.5X the normal institutional limits. If total bilirubin is outside the normal institutional limits, assess direct bilirubin. The direct bilirubin must be within normal parameters. Transaminases (SGOT and/or SGPT) must be less than 2.5X the institutional upper limit of normal.
• Documented ophthalmic exam within the last twelve months demonstrating no evidence of retinopathy. Patients with retinal changes will be considered for enrollment with written clearance from a board certified ophthalmologist.
• Must have a serum total testosterone level ≥150 ng/dL at the time of enrollment within 4 weeks prior to randomization.
• Must sign informed consent.

Exclusion Criteria

• Serious concomitant systemic disorder that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
• Must be off ADT in the neoadjuvant, adjuvant and/or salvage setting for at least 3 months and have a testosterone level > 150 ng/dl.
• Second primary malignancy except most situ carcinoma (e.g. adequately treated non-melanomatous carcinoma of the skin) or other malignancy treated at least 5 years previously with no evidence of recurrence.
• Rheumatoid arthritis or systemic lupus erythematosus treatment.
• Psoriasis.
• Receiving any disease-modifying anti-rheumatic drug (DMARD).
• Active clinically significant infection requiring antibiotics.
• G6PD deficiency.
• Taking other commercially available medications which may theoretically either stimulate or inhibit autophagy, which are calcitriol and chloroquine.
• Taking medications which may lead to interactions with hydroxychloroquine, including penicillamine, telbivudine, botulinum toxin, digoxin, and propafenone.
• Must not have 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Rutgers Cancer Institute of New Jersey

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Biren Saraiya, MD

Assistant Professor of Medicine Medical Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Biren Saraiya, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, United States

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Morristown, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Overlook Hospital

Summit, New Jersey, United States

Cooper University Hospital Cancer Institute

Voorhees Township, New Jersey, United States

Countries

United States

Other Identifiers

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0220080115

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2012-00528

Identifier Type: OTHER

Identifier Source: secondary_id

080803

Identifier Type: OTHER

Identifier Source: secondary_id

0220080115

Identifier Type: -

Identifier Source: org_study_id