20 Participants Needed

Hydroxychloroquine for Prostate Cancer

DI
Overseen ByDirector, IIT Office, PhD
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: Patrick Hensley
Must be taking: Hydroxychloroquine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

PJ

Patrick J Hensley, MD

Principal Investigator

University of Kentucky

PW

Peng Wang, MD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: HydroxychloroquineExperimental Treatment1 Intervention

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

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Approved in United States as Plaquenil for:
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Approved in European Union as Plaquenil for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Patrick Hensley

Lead Sponsor

Trials
1
Recruited
20+

Andrew C. James, MD

Lead Sponsor

Trials
1
Recruited
20+
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