Trial Outcomes & Findings for Hydroxychloroquine in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer (NCT NCT00726596)

NCT ID: NCT00726596

Last Updated: 2022-06-16

Results Overview

PSA response will be defined as a change in slope of at least 25%, when log (PSA) is plotted vs. time

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

64 participants

Primary outcome timeframe

6 years

Results posted on

2022-06-16

Participant Flow

Subjects were recruited through the Rutgers Cancer Institute of New Jersey Oncology Group. The study was open to accrual on 08/05/2008 and closed to accrual to 04/10/2013

We are reporting results on 64 eligible patients. 14 patients were deemed ineligible.

Participant milestones

Participant milestones
Measure	Cohort A. Hydroxychloroquine (200mg Bid) Hydroxychloroquine - 400 mg (cohort A) Hydroxychloroquine will be taken at a dose of 200 mg twice per day in the first 27 patients (cohort A).	Cohort B. Hydroxychloroquine (200mg Tid) Hydroxychloroquine - 600 mg (cohort B) Once cohort A is completed, the dose of hydroxychloroquine will then be increased to 600mg per day (200mg three times per day)(cohort B).
Overall Study STARTED	36	28
Overall Study COMPLETED	31	24
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A. Hydroxychloroquine (200mg Bid) Hydroxychloroquine - 400 mg (cohort A) Hydroxychloroquine will be taken at a dose of 200 mg twice per day in the first 27 patients (cohort A).	Cohort B. Hydroxychloroquine (200mg Tid) Hydroxychloroquine - 600 mg (cohort B) Once cohort A is completed, the dose of hydroxychloroquine will then be increased to 600mg per day (200mg three times per day)(cohort B).
Overall Study Adverse Event	2	1
Overall Study Withdrawal by Subject	3	3

Baseline Characteristics

Hydroxychloroquine in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A. Hydroxychloroquine (200mg Bid) n=36 Participants Hydroxychloroquine - 400 mg (cohort A) Hydroxychloroquine will be taken at a dose of 200 mg twice per day in the first 27 patients (cohort A).	Cohort B. Hydroxychloroquine (200mg Tid) n=28 Participants Hydroxychloroquine - 600 mg (cohort B) Once cohort A is completed, the dose of hydroxychloroquine will then be increased to 600mg per day (200mg three times per day)(cohort B).	Total n=64 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	31 Participants n=5 Participants	19 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	28 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	28 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	24 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants	28 participants n=7 Participants	64 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 years

PSA response will be defined as a change in slope of at least 25%, when log (PSA) is plotted vs. time

Outcome measures

Outcome measures
Measure	Cohort A. Hydroxychloroquine (200mg Bid) n=30 Participants Hydroxychloroquine - 400 mg (cohort A) Hydroxychloroquine will be taken at a dose of 200 mg twice per day in the first 27 patients (cohort A).	Cohort B. Hydroxychloroquine (200mg Tid) n=22 Participants Hydroxychloroquine - 600 mg (cohort B) Once cohort A is completed, the dose of hydroxychloroquine will then be increased to 600mg per day (200mg three times per day)(cohort B).
Prostate-specific Antigen (PSA) Response	48 percentage of participants	48 percentage of participants

SECONDARY outcome

Timeframe: 6 years

Population: Data was not collected and the outcome measure was not analyzed.

A change of at least 25% from baseline will be considered to be a significant response

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 years

Population: Data was not collected and the outcome measure was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 years

Population: Data was not collected and the outcome measure was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 years

Rate of adverse events were captured utilizing the CTCAE version3.0.

Outcome measures

Outcome measures
Measure	Cohort A. Hydroxychloroquine (200mg Bid) n=30 Participants Hydroxychloroquine - 400 mg (cohort A) Hydroxychloroquine will be taken at a dose of 200 mg twice per day in the first 27 patients (cohort A).	Cohort B. Hydroxychloroquine (200mg Tid) n=22 Participants Hydroxychloroquine - 600 mg (cohort B) Once cohort A is completed, the dose of hydroxychloroquine will then be increased to 600mg per day (200mg three times per day)(cohort B).
Feasibility and Safety of Administering Hydroxychloroquine in This Population of Patients. Rate of Adverse Events	30 Participants	22 Participants

Adverse Events

Cohort A. Hydroxychloroquine (200mg Bid)

Serious events: 1 serious events

Other events: 20 other events

Deaths: 1 deaths

Cohort B. Hydroxychloroquine (200mg Tid)

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A. Hydroxychloroquine (200mg Bid) n=36 participants at risk Hydroxychloroquine - 400 mg (cohort A) Hydroxychloroquine will be taken at a dose of 200 mg twice per day in the first 27 patients (cohort A).	Cohort B. Hydroxychloroquine (200mg Tid) n=28 participants at risk Hydroxychloroquine - 600 mg (cohort B) Once cohort A is completed, the dose of hydroxychloroquine will then be increased to 600mg per day (200mg three times per day)(cohort B).
Renal and urinary disorders Pain	2.8% 1/36 • Number of events 1 • Adverse events were collected over a period of 170 days per patient.	0.00% 0/28 • Adverse events were collected over a period of 170 days per patient.

Other adverse events

Additional Information

Mark Stein, MD

Rutgers Cancer Institute of New Jersey

Phone: 732-235-5773

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cohort A. Hydroxychloroquine (200mg Bid) n=36 participants at risk Hydroxychloroquine - 400 mg (cohort A) Hydroxychloroquine will be taken at a dose of 200 mg twice per day in the first 27 patients (cohort A).	Cohort B. Hydroxychloroquine (200mg Tid) n=28 participants at risk Hydroxychloroquine - 600 mg (cohort B) Once cohort A is completed, the dose of hydroxychloroquine will then be increased to 600mg per day (200mg three times per day)(cohort B).
Gastrointestinal disorders Diarrhea	55.6% 20/36 • Number of events 20 • Adverse events were collected over a period of 170 days per patient.	82.1% 23/28 • Number of events 23 • Adverse events were collected over a period of 170 days per patient.
Gastrointestinal disorders Nausea	55.6% 20/36 • Number of events 20 • Adverse events were collected over a period of 170 days per patient.	25.0% 7/28 • Number of events 7 • Adverse events were collected over a period of 170 days per patient.
General disorders Fatigue	5.6% 2/36 • Number of events 2 • Adverse events were collected over a period of 170 days per patient.	14.3% 4/28 • Number of events 4 • Adverse events were collected over a period of 170 days per patient.
Skin and subcutaneous tissue disorders Rash	8.3% 3/36 • Number of events 3 • Adverse events were collected over a period of 170 days per patient.	3.6% 1/28 • Number of events 1 • Adverse events were collected over a period of 170 days per patient.
Skin and subcutaneous tissue disorders Pruritus/Itching	5.6% 2/36 • Number of events 2 • Adverse events were collected over a period of 170 days per patient.	3.6% 1/28 • Number of events 1 • Adverse events were collected over a period of 170 days per patient.
Nervous system disorders Dizziness	5.6% 2/36 • Number of events 2 • Adverse events were collected over a period of 170 days per patient.	7.1% 2/28 • Number of events 2 • Adverse events were collected over a period of 170 days per patient.
Eye disorders Vision - blurred vision	8.3% 3/36 • Number of events 3 • Adverse events were collected over a period of 170 days per patient.	7.1% 2/28 • Number of events 2 • Adverse events were collected over a period of 170 days per patient.
Immune system disorders Allergic rhinitis	2.8% 1/36 • Number of events 1 • Adverse events were collected over a period of 170 days per patient.	7.1% 2/28 • Number of events 2 • Adverse events were collected over a period of 170 days per patient.
General disorders Pain	2.8% 1/36 • Number of events 1 • Adverse events were collected over a period of 170 days per patient.	7.1% 2/28 • Number of events 2 • Adverse events were collected over a period of 170 days per patient.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 2/36 • Number of events 2 • Adverse events were collected over a period of 170 days per patient.	7.1% 2/28 • Number of events 2 • Adverse events were collected over a period of 170 days per patient.
Blood and lymphatic system disorders Hemoglobin	0.00% 0/36 • Adverse events were collected over a period of 170 days per patient.	10.7% 3/28 • Number of events 3 • Adverse events were collected over a period of 170 days per patient.
Blood and lymphatic system disorders Leukocytes (total WBC)	0.00% 0/36 • Adverse events were collected over a period of 170 days per patient.	7.1% 2/28 • Number of events 2 • Adverse events were collected over a period of 170 days per patient.
Blood and lymphatic system disorders Neutrophils/granulocytes	0.00% 0/36 • Adverse events were collected over a period of 170 days per patient.	7.1% 2/28 • Number of events 2 • Adverse events were collected over a period of 170 days per patient.
General disorders Insomnia	0.00% 0/36 • Adverse events were collected over a period of 170 days per patient.	7.1% 2/28 • Number of events 2 • Adverse events were collected over a period of 170 days per patient.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/36 • Adverse events were collected over a period of 170 days per patient.	7.1% 2/28 • Number of events 2 • Adverse events were collected over a period of 170 days per patient.
Gastrointestinal disorders Constipation	0.00% 0/36 • Adverse events were collected over a period of 170 days per patient.	7.1% 2/28 • Number of events 2 • Adverse events were collected over a period of 170 days per patient.
Gastrointestinal disorders Heartburn/dyspepsia	0.00% 0/36 • Adverse events were collected over a period of 170 days per patient.	17.9% 5/28 • Number of events 5 • Adverse events were collected over a period of 170 days per patient.
Investigations Creatinine	0.00% 0/36 • Adverse events were collected over a period of 170 days per patient.	10.7% 3/28 • Number of events 3 • Adverse events were collected over a period of 170 days per patient.
Investigations Glucose, serum high	0.00% 0/36 • Adverse events were collected over a period of 170 days per patient.	14.3% 4/28 • Number of events 4 • Adverse events were collected over a period of 170 days per patient.
Investigations Hyperkalemia	0.00% 0/36 • Adverse events were collected over a period of 170 days per patient.	7.1% 2/28 • Number of events 2 • Adverse events were collected over a period of 170 days per patient.