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

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ClinicalTrials.gov Identifier: NCT04011410
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : October 26, 2022
Information provided by (Responsible Party):
Andrew C. James, MD, University of Kentucky

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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, non-blinded, open label clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
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 : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Hydroxychloroquine

Hydroxychloroquine (HCQ)

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.


Drug: Hydroxychloroquine Sulfate 200Mg Tab
Twice daily for 90-days, administered two weeks prior to radiation/surgery of oligometastatic lesions
Other Names:
  • Hydroxychloroquine
  • plaquenil
  • plaquenil sulfate
  • quineprox

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

Other Outcome Measures:
  1. 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

  2. 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.

  3. 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

  4. Hydroxychloroquine (HCQ) Adherence [ Time Frame: 3 months ]
    Medication logs will be used to assess daily adherence to HCQ dosage (yes/no).

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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

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Contact: Director, IIT Office, PhD 859-323-6731 leighanne.faul@uky.edu

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United States, Kentucky
Markey Cancer Center - University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Director, IIT Office    859-323-6731    leighanne.faul@uky.edu   
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         
Sponsors and Collaborators
Andrew C. James, MD
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Principal Investigator: Andrew C James, MD University of Kentucky
Principal Investigator: Peng Wang, MD University of Kentucky

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Responsible Party: Andrew C. James, MD, Assistant Professor, Dept of Urology, University of Kentucky
ClinicalTrials.gov Identifier: NCT04011410    
Other Study ID Numbers: 50146 - MCC-19-GU-72
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: October 26, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD that underlie results in a publication detailing the primary endpoint
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 6 months after publication

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Andrew C. James, MD, University of Kentucky:
Prostate Cancer
Oligometastatic Prostate Cancer
Limited Metastatic Disease
Metastatic Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents