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

Completed · Phase 2

Conditions studied: Prostate Cancer Recurrent

In brief

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.

Key facts

Study ID

NCT04011410

Run by

Patrick Hensley

People needed

20

Starts

2019-12-03

Expected to finish

2024-03-08

Last updated by the study team

2025-04-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Markey Cancer Center - University of Kentucky — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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