Hydroxychloroquine to Increase Tumor Suppressor PAR-4 Levels in Oligometastatic Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04011410|
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Recurrent||Drug: Hydroxychloroquine Sulfate 200Mg Tab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm, non-blinded, open label clinical trial|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Hydroxychloroquine to Increase Tumor Suppressor PAR-4 Levels in Oligometastatic Prostate Cancer|
|Actual Study Start Date :||December 3, 2019|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2022|
DOSAGE FORM: 200 mg tablet, oral route
DOSAGE: 200 mg BID by mouth, for a total daily dose of 400 mg
FREQUENCY: HCQ is taken twice daily (morning and night) with food.
DURACTION OF HCQ: 90-days
Drug: Hydroxychloroquine Sulfate 200Mg Tab
Twice daily for 90-days, administered two weeks prior to radiation/surgery of oligometastatic lesions
- Change in Prostate Apoptosis Response-4 (PAR-4) Levels [ Time Frame: 7 timepoints: Baseline, 2 weeks prior to radiation/surgery, 30-, 60- & 90-days post-HCQ initiation; and follow-up timepoints at 6- and 12-months ]PAR-4 levels measured via serum or plasma blood sample
- Change in Serum Prostate Specific Antigen (PSA) Levels [ Time Frame: 6 timepoints: screening, baseline, 30-, & 90-days post-HCQ initiation; and at 6- and 12-mos follow-up ]Doubling time of serum PSA levels
- Progression-Free Survival [ Time Frame: through study completion (up to 3 years) ]Assessed via imaging per standard of care using Response Evaluation Criteria in Solid Tumours (RECIST) scoring criteria
- Androgen Deprivation Therapy (ADT)-Free Survival [ Time Frame: through study completion (up to 3 years) ]Time to initiation of ADT using the Kaplan-Meier method
- Quality of Life (QoL) - EORTC QLQ-C30 Scale [ Time Frame: 4 timepoints: baseline/enrollment, 90-days post-HCQ initiation, and 6- and 12-mos follow-up ]The European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire (QLQ)-C30 is a 30-item, multi-set questionnaire. Scores range from 0-100, with higher scores indicating higher response levels
- Change in Quality of Life (QoL) - EORTC QLQ-PR25 Scale [ Time Frame: 4 timepoints: baseline/enrollment, 90-days post-HCQ initiation, and 6- and 12-months follow-up ]The EORTC Quality of Life (QLQ)-PR25 is a 28-item, multi-set questionaire specific to prostate cancer that complements the QLQ-C30. Scores range from 0-100, with higher scores indicating higher response levels.
- Change in Peripheral Blood Mononuclear Cells (PBMCs) [ Time Frame: 3 timepoints: baseline/enrollment, 30-days post-HCQ initiation, and 60-90 days post-HCQ initiation ]PBMC numbers will be correlated with PSA and PAR-4 levels
- Hydroxychloroquine (HCQ) Adherence [ Time Frame: 3 months ]Medication logs will be used to assess daily adherence to HCQ dosage (yes/no).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011410
|Contact: Director, IIT Office, PhDemail@example.com|
|United States, Kentucky|
|Markey Cancer Center - University of Kentucky||Recruiting|
|Lexington, Kentucky, United States, 40536|
|Contact: Director, IIT Office 859-323-6731 firstname.lastname@example.org|
|Contact: Associate Director of Clinical Translation 859-257-4488|
|Principal Investigator: Andrew C James, MD|
|Sub-Investigator: Peng Wang, MD|
|Sub-Investigator: Vivek Rangnekar, PhD|
|Sub-Investigator: Don Cohen, PhD|
|Principal Investigator:||Andrew C James, MD||University of Kentucky|
|Principal Investigator:||Peng Wang, MD||University of Kentucky|