Status:
COMPLETED
Hydroxychloroquine to Increase Tumor Suppressor PAR-4 Levels in Oligometastatic Prostate Cancer
Lead Sponsor:
Patrick Hensley
Conditions:
Prostate Cancer Recurrent
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
This investigator-initiated clinical trial (IIT) builds on and extends research on autophagy in prostate cancer with PAR-4 and HCQ conducted by a transdisciplinary investigative team, and is sponsored...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04011410
Start Date
December 3 2019
End Date
March 8 2024
Last Update
April 11 2025
Active Locations (1)
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1
Markey Cancer Center - University of Kentucky
Lexington, Kentucky, United States, 40536