Hydroxychloroquine to Increase Tumor Suppressor PAR-4 Levels in Oligometastatic Prostate Cancer (NCT04011410) | Clinical Trial Compass
CompletedPhase 2
Hydroxychloroquine to Increase Tumor Suppressor PAR-4 Levels in Oligometastatic Prostate Cancer
United States20 participantsStarted 2019-12-03
Plain-language summary
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 can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed prostate cancer that has recurred
* Three or fewer synchronous metastatic lesions (on imaging) with no evidence of residual local disease
* ECOG performance status 0 - 2
* Approval by screening eye exam (disqualifying baseline conditions listed below)
* Ability to provide informed consent
Exclusion Criteria:
* Receipt of hydroxychloroquine (HCQ) within the past 6 months
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to HCQ
* Use of contraindicated medications,
* Macular degeneration
* Cataracts
* Severe baseline visual impairment, retinopathy or visual field changes
* Presence of only one functional eye
* Prior treatment with ADT including:
* Previous history of radiation or surgery to a metastatic site
* Serum testosterone less than 50 ng/ml
* History of orchiectomy
* History of pathologic fracture or spinal cord compression
* Brain or CNS metastases
* History of G-6-PD (glucose-6-phosphate dehydrogenase) deficiency
* Uncontrolled intercurrent illness
* Psychiatric illness and/or social situations that would limit compliance with study requirements.
* Patients taking other investigational agents
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participants With Greater Than or Equal to 50% Induction in Serum PAR4 Levels