CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Hydroxychloroquine Sulfate 200Mg Tabdrug
Likely dose
Hydroxychloroquine Sulfate 200Mg Tabfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04011410
NCT04011410Phase 2Completed

Phase 2 Study of Hydroxychloroquine to Increase Tumor Suppressor PAR-4 Levels in Oligometastatic Prostate Cancer

Patrick Hensley·interventional·Posted Jul 8, 2019·Updated Apr 11, 2025

In Brief

A Phase 2 clinical trial evaluating Hydroxychloroquine Sulfate 200Mg Tab for Prostate Cancer Recurrent. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 8, 2019
Enrollment StartDec 3, 2019
Primary CompletionMar 8, 2024
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 7.0 years ago

Interventions

Hydroxychloroquine Sulfate 200Mg Tabdrug

Twice daily for 90-days, administered two weeks prior to radiation/surgery of oligometastatic lesions