Prostate CancerPhase 2NCT00726596
Hydroxychloroquine in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer
A Phase 2 study testing hydroxychloroquine in people with Prostate Cancer, run by Rutgers, The State University of New Jersey at 5 sites in United States.
Trial summary
This phase II trial studies how well hydroxychloroquine works in treating patients with previously treated prostate cancer. Autophagy destroys proteins and other substances in cells and may be used by prostate cancer cells to survive. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- hydroxychloroquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2008to Jan 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven stage D0 prostate cancer (i.e., tumor originally diagnosed as being limited to the prostate) or D1 prostate cancer (metastatic to regional lymph nodes) and have a rising PSA value after definitive local therapy.
- Must have undergone local treatment via prostatectomy or radiation therapy.
- Must have PSA progression after local treatment:
- PSA values for patients after surgery must be > 0.2 ng/mL, determined by two measurements, at least 1 month apart and at least 6 months after prostatectomy
- PSA values for patients after radiation must be ≥ 2.0 ng/ml greater than the nadir achieved after radiation, determined by two measurements at 1 month apart and at least 6 months after the radiation treatment is completed. (Patients who received adjuvant or salvage radiation after prostatectomy must have PSA of >0.2)
- The first two PSA values (in 5.1.3a and 5.1.3b), along with a third (study baseline) value must all be rising (i.e., there must be an overall rising trajectory, such that the third value cannot be lower than the first value).
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- Baseline bone scan and CT abdomen/pelvis demonstrating no metastatic disease.
- Age ≥ 18 years
- Estimated life expectancy of at least 6 months.
- ECOG performance status < 2. (see Appendix B)
- A WBC > 3500/μl, ANC >1500/μl, hemoglobin > 10 g/dl, and platelet count >100,000/μl are required.
- Adequate renal function (serum creatinine < 1.5 mg/dL or creatinine clearance > 50 ml/min).
- Total bilirubin must be within 1.5X the normal institutional limits. If total bilirubin is outside the normal institutional limits, assess direct bilirubin. The direct bilirubin must be within normal parameters. Transaminases (SGOT and/or SGPT) must be less than 2.5X the institutional upper limit of normal.
- Documented ophthalmic exam within the last twelve months demonstrating no evidence of retinopathy. Patients with retinal changes will be considered for enrollment with written clearance from a board certified ophthalmologist.
- Must have a serum total testosterone level ≥150 ng/dL at the time of enrollment within 4 weeks prior to randomization.
- Must sign informed consent.
Who cannot join
- Serious concomitant systemic disorder that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
- Must be off ADT in the neoadjuvant, adjuvant and/or salvage setting for at least 3 months and have a testosterone level > 150 ng/dl.
- Second primary malignancy except most situ carcinoma (e.g. adequately treated non-melanomatous carcinoma of the skin) or other malignancy treated at least 5 years previously with no evidence of recurrence.
- Rheumatoid arthritis or systemic lupus erythematosus treatment.
- Psoriasis.
- Receiving any disease-modifying anti-rheumatic drug (DMARD).
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- Active clinically significant infection requiring antibiotics.
- G6PD deficiency.
- Taking other commercially available medications which may theoretically either stimulate or inhibit autophagy, which are calcitriol and chloroquine.
- Taking medications which may lead to interactions with hydroxychloroquine, including penicillamine, telbivudine, botulinum toxin, digoxin, and propafenone.
- Must not have visual field changes from prior 4-aminoquinoline compound use.
- Must not be taking hydroxychloroquine for treatment or prophylaxis of malaria.
- History of hypersensitivity to 4-aminoquinoline compound.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, 08690
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, 07962
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Overlook Hospital
Summit, New Jersey, 07901
Cooper University Hospital Cancer Institute
Voorhees Township, New Jersey, 08043
About this study
Official title: NJ 1808: Autophagic Cell Death With Hydroxychloroquine in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy For Prostate Cancer.
This phase II trial studies how well hydroxychloroquine works in treating patients with previously treated prostate cancer. Autophagy destroys proteins and other substances in cells and may be used by prostate cancer cells to survive. Hydroxychloroquine, which blocks autophagy, may slow the growth of and possibly kill prostate cancer cells.
- Conditions
- Prostate Cancer
- Being tested
- hydroxychloroquine
- Keywords
- recurrent prostate cancer, stage IV prostate cancer, Prostate-Specific Antigen
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine will be taken at a dose of 200 mg twice per day in the first 27 patients (cohort A). Once cohort A completed, the dose of hydroxychloroquine will then be increased to 600mg per day (200mg three times per day)(cohort B).
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Experimental | Hydroxychloroquine - 400 mg (cohort A) Hydroxychloroquine - 600 mg (cohort B) Receives: Drug: hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate-specific Antigen (PSA) Response
PSA response will be defined as a change in slope of at least 25%, when log (PSA) is plotted vs. time
Measured: 6 years
Secondary outcomes (4)
Effect on Peripheral Blood Mononuclear Cell (PBMC) LC3 Expression by the Use of Hydroxychloroquine
A change of at least 25% from baseline will be considered to be a significant response
Measured: 6 years
Effect on PBMC Autophagic Vesicle Formation by the Use of Hydroxychloroquine
Measured: 6 years
Expression of Beclin-1 in a Population of Patients Having Undergone Local Treatment With Prostatectomy
Measured: 6 years
Feasibility and Safety of Administering Hydroxychloroquine in This Population of Patients. Rate of Adverse Events
Rate of adverse events were captured utilizing the CTCAE version3.0.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionFeb 2014
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Biren Saraiya, MD, Rutgers Cancer Institute of New Jersey
- Investigators
- Biren Saraiya, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726596
- Sponsor's protocol ID
- 0220080115
- Other IDs
- P30CA072720, 0220080115, NCI-2012-00528, 080803
- Status last verified
- Jun 2022
- First submitted
- 31 Jul 2008
- Last updated
- 16 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NJ 1808: Autophagic Cell Death With Hydroxychloroquine in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy For Prostate Cancer.
- ClinicalTrials.gov ID
- NCT00726596
- Acronym / sponsor ID
- 0220080115
- Conditions
- Prostate Cancer
- Keywords
- recurrent prostate cancer, stage IV prostate cancer, Prostate-Specific Antigen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey, National Cancer Institute (NCI)
- Study start
- Aug 2008
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 1 Aug 2008 (estimated)
- Results
- Posted 16 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well hydroxychloroquine works in treating patients with previously treated prostate cancer. Autophagy destroys proteins and other substances in cells and may be used by prostate cancer cells to survive. Hydroxychloroquine, which blocks autophagy, may slow the growth of and possibly kill prostate cancer cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Experimental | Drug: hydroxychloroquineHydroxychloroquine - 400 mg (cohort A) Hydroxychloroquine - 600 mg (cohort B) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically proven stage D0 prostate cancer (i.e., tumor originally diagnosed as being limited to the prostate) or D1 prostate cancer (metastatic to regional lymph nodes) and have a rising PSA value after definitive local therapy.
- Must have undergone local treatment via prostatectomy or radiation therapy.
- Must have PSA progression after local treatment:
- Baseline bone scan and CT abdomen/pelvis demonstrating no metastatic disease.
- Age ≥ 18 years
Key exclusion criteria (13 listed)
- Serious concomitant systemic disorder that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
- Must be off ADT in the neoadjuvant, adjuvant and/or salvage setting for at least 3 months and have a testosterone level > 150 ng/dl.
- Second primary malignancy except most situ carcinoma (e.g. adequately treated non-melanomatous carcinoma of the skin) or other malignancy treated at least 5 years previously with no evidence of recurrence.
- Rheumatoid arthritis or systemic lupus erythematosus treatment.
- Psoriasis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydroxychloroquineHydroxychloroquine will be taken at a dose of 200 mg twice per day in the first 27 patients (cohort A). Once cohort A completed, the dose of hydroxychloroquine will then be increased to 600mg per day (200mg three times per day)(cohort B). | Drug | Hydroxychloroquine |
Primary outcome
Prostate-specific Antigen (PSA) Response
Time frame: 6 years
PSA response will be defined as a change in slope of at least 25%, when log (PSA) is plotted vs. time
4 secondary outcomes
Effect on Peripheral Blood Mononuclear Cell (PBMC) LC3 Expression by the Use of Hydroxychloroquine
Time frame: 6 years
Effect on PBMC Autophagic Vesicle Formation by the Use of Hydroxychloroquine
Time frame: 6 years
Expression of Beclin-1 in a Population of Patients Having Undergone Local Treatment With Prostatectomy
Time frame: 6 years
Feasibility and Safety of Administering Hydroxychloroquine in This Population of Patients. Rate of Adverse Events
Time frame: 6 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Biren Saraiya, MD principal investigator
Rutgers Cancer Institute of New Jersey
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hydroxychloroquine in people with Prostate Cancer, run by Rutgers, The State University of New Jersey at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate-specific Antigen (PSA) Response (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.