Trial Outcomes & Findings for Hydroxychloroquine to Increase Tumor Suppressor PAR-4 Levels in Oligometastatic Prostate Cancer (NCT NCT04011410)

NCT ID: NCT04011410

Last Updated: 2025-04-11

Results Overview

Number of participants that attained greater than or equal to 50% induction over baseline of PAR-4 levels as measured via serum or plasma blood sample

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2025-04-11

Participant Flow

Participant milestones

Measure	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. DURACTION OF HCQ: 90-days Hydroxychloroquine Sulfate 200Mg Tab: Twice daily for 90-days, administered two weeks prior to radiation/surgery of oligometastatic lesions
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	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. DURACTION OF HCQ: 90-days Hydroxychloroquine Sulfate 200Mg Tab: Twice daily for 90-days, administered two weeks prior to radiation/surgery of oligometastatic lesions
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Hydroxychloroquine n=19 Participants 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. DURACTION OF HCQ: 90-days Hydroxychloroquine Sulfate 200Mg Tab: Twice daily for 90-days, administered two weeks prior to radiation/surgery of oligometastatic lesions
Age, Continuous	69 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Number of participants that attained greater than or equal to 50% induction over baseline of PAR-4 levels as measured via serum or plasma blood sample

Outcome measures

Measure	Hydroxychloroquine n=19 Participants 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. DURACTION OF HCQ: 90-days Hydroxychloroquine Sulfate 200Mg Tab: Twice daily for 90-days, administered two weeks prior to radiation/surgery of oligometastatic lesions
Participants With Greater Than or Equal to 50% Induction in Serum PAR4 Levels	11 Participants

SECONDARY outcome

Timeframe: 5 timepoints: baseline, 30-, & 90-days post-HCQ initiation; and at 6- and 12-mos follow-up

Doubling time of serum PSA levels

Outcome measures

Measure	Hydroxychloroquine n=19 Participants 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. DURACTION OF HCQ: 90-days Hydroxychloroquine Sulfate 200Mg Tab: Twice daily for 90-days, administered two weeks prior to radiation/surgery of oligometastatic lesions
Change in Serum Prostate Specific Antigen (PSA) Levels Baseline	8.60 ng/ml Standard Deviation 8.373
Change in Serum Prostate Specific Antigen (PSA) Levels 30 days	10.91 ng/ml Standard Deviation 10.875
Change in Serum Prostate Specific Antigen (PSA) Levels 90 days	14.46 ng/ml Standard Deviation 23.281
Change in Serum Prostate Specific Antigen (PSA) Levels 6 months	7.54 ng/ml Standard Deviation 12.190
Change in Serum Prostate Specific Antigen (PSA) Levels 12 months	0.38 ng/ml Standard Deviation 0.794

SECONDARY outcome

Timeframe: 1 year progression free survival

Assessed via imaging per standard of care using Response Evaluation Criteria in Solid Tumours (RECIST) scoring criteria

Outcome measures

Measure	Hydroxychloroquine n=19 Participants 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. DURACTION OF HCQ: 90-days Hydroxychloroquine Sulfate 200Mg Tab: Twice daily for 90-days, administered two weeks prior to radiation/surgery of oligometastatic lesions
Number of Participants With Progression-Free Survival	6 Participants

SECONDARY outcome

Timeframe: 1 year ADT free survival

ADT-free Survival is defined as the time between study enrollment until the start of ADT or death

Outcome measures

Measure	Hydroxychloroquine n=19 Participants 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. DURACTION OF HCQ: 90-days Hydroxychloroquine Sulfate 200Mg Tab: Twice daily for 90-days, administered two weeks prior to radiation/surgery of oligometastatic lesions
Number of Participants With Androgen Deprivation Therapy (ADT)-Free Survival	8 Participants

Adverse Events

Hydroxychloroquine

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Hydroxychloroquine n=19 participants at risk 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. DURACTION OF HCQ: 90-days Hydroxychloroquine Sulfate 200Mg Tab: Twice daily for 90-days, administered two weeks prior to radiation/surgery of oligometastatic lesions
Gastrointestinal disorders Gastrointestinal distress	47.4% 9/19 • Number of events 9 • Adverse event data was collected from study enrollment up to 12 months after study initiation.
General disorders Generalized distress (fatigue/pain)	26.3% 5/19 • Number of events 5 • Adverse event data was collected from study enrollment up to 12 months after study initiation.
Metabolism and nutrition disorders Metabolic disturbance	21.1% 4/19 • Number of events 4 • Adverse event data was collected from study enrollment up to 12 months after study initiation.

Additional Information

Patrick Hensley

University of Kentucky College of Medicine

Phone: 859-562-3223

Email: patrick.hensley@uky.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place