This phase II trial studies how well hydroxychloroquine works in treating patients with prostate cancer that has come back (recurrent) and has spread to a limited number of sites (oligometastatic). PAR-4 is a protein that causes cell death in cancer cells, but the amount of it made by normal cells is not enough to cause massive cancer cell death. Hydroxychloroquine may increase PAR-4 levels which helps kill more cancer cells.
Additional locations may be listed on ClinicalTrials.gov for NCT04011410.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Assess the rate of attainment of a 50% increase in tumor suppressor PAR-4 levels from baseline in patients treated with 90-days of hydroxychloroquine (HCQ) in combination with radiation or surgery for recurrent, oligometastatic prostate cancer.
SECONDARY OBJECTIVES:
I. Median progression-free survival (time to clinical progression).
II. 1- and 3-year androgen deprivation therapy (ADT) free survival.
III. HCQ treatment toxicity (adverse events [AEs] and serious adverse events [SAEs] during HCQ administration) and radiation toxicity to be assessed and recorded utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
IV. Immunological effect of HCQ by analyzing peripheral blood mononuclear cells (PBMCs) at day 0 and day 30 of treatment, and also, day 60 (+ 6 weeks) of treatment.
V. Quality of life as measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - Core (C) 30 + QLQ - Prostate (PR) 25.
OUTLINE:
Patients receive hydroxychloroquine orally (PO) twice daily (BID) for 2 weeks, then undergo standard of care stereotactic body radiation therapy (SBRT) or metastasectomy. Patients then receive hydroxychloroquine PO BID beginning post-operative day 1 for 3 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30, 60, and 90 days, at 6 months, then at 1, 2, and 3 years.
Lead OrganizationUniversity of Kentucky/Markey Cancer Center
Principal InvestigatorPatrick J Hensley
