Hydroxychloroquine for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byPatrick J Hensley, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Patrick Hensley

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Men with recurrent oligometastatic prostate cancer, who have had surgery or radiation, can join this trial. They should have three or fewer metastatic lesions and no local disease left. Participants must be able to consent, perform daily activities (ECOG 0-2), and pass an eye exam. Those with allergies to similar drugs, severe eye conditions, prior HCQ use within 6 months, brain metastases, or on ADT are excluded.

Inclusion Criteria

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

I have up to 3 cancer spread sites and no remaining local cancer.

My prostate cancer has come back after treatment.

See 2 more

Exclusion Criteria

I have severe vision problems or changes in my eyesight.

My cancer has spread to my brain or central nervous system.

I can only see out of one eye.

See 14 more

Treatment Details

Interventions

Hydroxychloroquine (Other)

Trial OverviewThe trial tests if Hydroxychloroquine (400 mg daily for 3 months) can delay prostate cancer progression by increasing PAR-4 levels in patients after standard treatments like surgery or radiation. The goal is to postpone the need for further therapies while maintaining life quality.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: HydroxychloroquineExperimental Treatment1 Intervention

Hydroxychloroquine (HCQ) DOSAGE FORM: 200 mg tablet, oral route DOSAGE: 200 mg BID by mouth, for a total daily dose of 400 mg FREQUENCY: HCQ is taken twice daily (morning and night) with food. DURACTION OF HCQ: 90-days

Hydroxychloroquine is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Plaquenil for: