NCT04011410CompletedPhase 2
Hydroxychloroquine to Increase Tumor Suppressor PAR-4 Levels in Oligometastatic Prostate Cancer
Phase 2 Study of Hydroxychloroquine to Increase Tumor Suppressor PAR-4 Levels in Oligometastatic Prostate Cancer
Source: ClinicalTrials.gov · Last updated 11 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 1 Jul 2019
- Start date
- 3 Dec 2019
- Primary completion date
- 8 Mar 2024
- Lead sponsor
- Patrick Hensley
- Diseases
- Prostate cancer
- NCT number
- NCT04011410
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 20
- From 3 Dec 2019 to the primary completion date, 8 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of contraindicated medications,
- Prior treatment with ADT including:
- Previous history of radiation or surgery to a metastatic site
- Patients taking other investigational agents
Other illness
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to HCQ
- Severe baseline visual impairment, retinopathy or visual field changes
- History of orchiectomy
- History of pathologic fracture or spinal cord compression
- Uncontrolled intercurrent illness
- Psychiatric illness and/or social situations that would limit compliance with study requirements.
Lab values
- Serum testosterone less than 50 ng/ml
- History of G-6-PD (glucose-6-phosphate dehydrogenase) deficiency
Other
- Receipt of hydroxychloroquine (HCQ) within the past 6 months
- Macular degeneration
- Cataracts
- Presence of only one functional eye
- Brain or CNS metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Markey Cancer Center - University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.