Hydroxychloroquine for Prostate Cancer

Overseen By Director, IIT Office, PhD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Patrick Hensley

Must be taking: Hydroxychloroquine

Must not be taking: Investigational agents

Disqualifiers: Macular degeneration, Cataracts, G-6-PD deficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

20 Participants Needed

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.

Research Team

Patrick J Hensley, MD

Principal Investigator

University of Kentucky

Peng Wang, MD

Principal Investigator

University of Kentucky

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 400 mg of Hydroxychloroquine per day for 3 months, in addition to standard care treatment of either surgical resection or stereotactic radiation

12 weeks

Regular visits as per standard care

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

12 months

4 visits (in-person) at 3, 6, 9, and 12 months

Treatment Details

Interventions

• Hydroxychloroquine

Trial Overview The 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

Group I: Hydroxychloroquine Experimental Treatment 1 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:

• Malaria
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus

Approved in European Union as Plaquenil for:

• Malaria
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus

Who Is Running the Clinical Trial?

Patrick Hensley

Lead Sponsor

Trials

1

Recruited

20+

Andrew C. James, MD

Lead Sponsor

Trials

1

Recruited

20+