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Hydroxychloroquine for Prostate Cancer

Phase 2

Waitlist Available

Led By Andrew C James, MD

Research Sponsored by Patrick Hensley

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Histologically confirmed prostate cancer that has recurred

Must not have

Severe baseline visual impairment, retinopathy or visual field changes

Brain or CNS metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion (up to 3 years)

Awards & highlights

Summary

This trial is testing whether adding Hydroxychloroquine to current treatment regimens for recurrent oligometastatic prostate cancer will improve outcomes.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Hydroxychloroquine may cause mild side effects; however it's expected that participants will experience few if any. Possible side effects include digestive issues, headaches, vision changes and skin rashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My prostate cancer has come back after treatment.

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I am able to care for myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe vision problems or changes in my eyesight.

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

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I can only see out of one eye.

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I have had surgery to remove one or both of my testicles.

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I have had surgery or radiation for cancer that spread.

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I have cataracts.

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I do not have any unmanaged ongoing illnesses.

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I am not taking any medications that are not allowed in the study.

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I have macular degeneration.

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I have previously been treated with hormone therapy for cancer.

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I have had a fracture or spinal cord compression due to cancer.

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I have a history of G-6-PD deficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion (up to 3 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion (up to 3 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (up to 3 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Prostate Apoptosis Response-4 (PAR-4) Levels

Secondary study objectives

Androgen Deprivation Therapy (ADT)-Free Survival

Change in Serum Prostate Specific Antigen (PSA) Levels

Progression-Free Survival

Other study objectives

Change in Peripheral Blood Mononuclear Cells (PBMCs)

Change in Quality of Life (QoL) - EORTC QLQ-PR25 Scale

Hydroxychloroquine (HCQ) Adherence

+1 more

Side effects data

From 2021 Phase 4 trial • 93 Patients • NCT03122431

60%

Only sensory peripheral neuropathy

100%

80%

60%

40%

20%

Study treatment Arm

SLE/Cutaneous Lupus With Thalidomide

Inactive SLE With Standard Dose of HCQ

Inactive SLE With Reduced Dose of HCQ

Trial Design

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

0 / 15Eligibility criteria met