Phase 2 N=20 Treatment

Hydroxychloroquine to Increase Tumor Suppressor PAR-4 Levels in Oligometastatic Prostate Cancer

Prostate Cancer Recurrent

Bottom Line

View on ClinicalTrials.gov: NCT04011410 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Participants With Greater Than or Equal to 50% Induction in Serum PAR4 Levels — 11 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Hydroxychloroquine Sulfate 200Mg Tab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Patrick Hensley
Primary completion: Mar 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Participants With Greater Than or Equal to 50% Induction in Serum PAR4 Levels	11	—
SECONDARY Change in Serum Prostate Specific Antigen (PSA) Levels	8.60; 10.91; 14.46; 7.54; 0.38	—
SECONDARY Number of Participants With Progression-Free Survival	6	—
SECONDARY Number of Participants With Androgen Deprivation Therapy (ADT)-Free Survival	8	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04011410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.