Hydroxychloroquine to Increase Tumor Suppressor PAR-4 Levels in Oligometastatic Prostate Cancer

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

Treatment of recurrent oligometastatic prostate cancer may be enhanced by the addition of Hydroxychloroquine to the current treatment regimens. Potential benefits of Hydroxychloroquine include delayed disease progression and delayed initiation of androgen deprivation therapy (ADT), thus lessening morbidity, distressing side effects, and improving functioning and quality of life in men with recurrent prostate cancer.

Building on prior research at Markey, patients recently diagnosed with recurrent oligometastatic prostate cancer will be approached about participating in this study. Per standard of care, these patients undergo either surgery or radiation, in addition participants of this clinical trial will also receive Hydroxychloroquine (400 mg per day, oral medication) for 3 months.

It is expected that a participant will exhibit a 50% increase of tumor suppressor PAR-4, as well as few, if any, negative side effects from Hydroxychloroquine.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andrew C. James, MD; University of Kentucky
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

• Histologically confirmed prostate cancer that has recurred

• Three or fewer synchronous metastatic lesions (on imaging) with no evidence of residual local disease

• ECOG performance status 0 - 2

• Approval by screening eye exam (disqualifying baseline conditions listed below)

• Ability to provide informed consent

Exclusion Criteria:

• Receipt of hydroxychloroquine (HCQ) within the past 6 months

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to HCQ

• Use of contraindicated medications,

• Macular degeneration

• Cataracts

• Severe baseline visual impairment, retinopathy or visual field changes

• Presence of only one functional eye

• Prior treatment with ADT including:

• Previous history of radiation or surgery to a metastatic site

• Serum testosterone less than 50 ng/ml

• History of orchiectomy

• History of pathologic fracture or spinal cord compression

• Brain or CNS metastases

• History of G-6-PD (glucose-6-phosphate dehydrogenase) deficiency

• Uncontrolled intercurrent illness

• Psychiatric illness and/or social situations that would limit compliance with study requirements.

• Patients taking other investigational agents