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Hydroxychloroquine for Prostate Cancer
Phase 2
Waitlist Available
Led By Patrick J Hensley, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (up to 3 years)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have up to 3 cancer spread sites and no remaining local cancer.
Select...
My prostate cancer has come back after treatment.
Select...
I am able to care for myself and perform daily activities.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Prostate Apoptosis Response-4 (PAR-4) Levels
Secondary outcome measures
Androgen Deprivation Therapy (ADT)-Free Survival
Change in Serum Prostate Specific Antigen (PSA) Levels
Progression-Free Survival
Other outcome measures
Change in Peripheral Blood Mononuclear Cells (PBMCs)
Change in Quality of Life (QoL) - EORTC QLQ-PR25 Scale
Hydroxychloroquine (HCQ) Adherence
+1 moreSide effects data
From 2021 Phase 4 trial • 93 Patients • NCT0312243160%
Only sensory peripheral neuropathy
100%
80%
60%
40%
20%
0%
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
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Who is running the clinical trial?
Patrick HensleyLead Sponsor
Andrew C. James, MDLead Sponsor
Patrick J Hensley, MDPrincipal InvestigatorUniversity of Kentucky
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have had surgery to remove one or both of my testicles.I have up to 3 cancer spread sites and no remaining local cancer.I have taken hydroxychloroquine in the last 6 months.My prostate cancer has come back after treatment.You are currently participating in another study using an experimental medication.I have had surgery or radiation for cancer that spread.You have a mental health condition or lifestyle that may make it difficult for you to follow the study requirements.I have cataracts.I do not have any unmanaged ongoing illnesses.I am not taking any medications that are not allowed in the study.I have macular degeneration.I am able to care for myself and perform daily activities.You have had an allergic reaction to drugs that are similar to HCQ.I have previously been treated with hormone therapy for cancer.I have had a fracture or spinal cord compression due to cancer.I have a history of G-6-PD deficiency.
Research Study Groups:
This trial has the following groups:- Group 1: Hydroxychloroquine
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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