- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01118741
Study of Recurrent Prostate Cancer With Rising Prostate Specific Antigen (PSA)
A Multi-institutional Translational Clinical Trial of Disulfiram in Men With Recurrent Prostate Cancer as Evident by a Rising PSA
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21231
- Johns Hopkins Hospital
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson Universith
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Provide written informed consent and HIPAA authorization for the release of personal health information.
- Adult male ≥18 years of age
- No desire to drink any alcohol during the study period. (The potential for ethanol interactions may last 7 to 14 days. Patient is allowed to drink alcohol 2 weeks after the study is finished)
- Histological confirmed diagnosis of adenocarcinoma of the prostate (M0) with evidence of biochemical relapse after local therapy (i.e., surgery, radiation therapy, or both). Baseline PSA must be ≥ 1 ng/ml.
- There must be a confirmed rise in PSA shown by 2 PSA values at least 1 week apart, higher than a reference value noted within 12 months of study entry. Interim PSA values during the immediate pre-study 12-month interval may demonstrate a "fluctuation" including a decline; however the study baseline PSA must have show a rise within the pre-study 12-months period. Baseline PSA must be determined within 4 weeks of study entry. At least 3 PSA values are necessary to calculate PSA doubling time via PSADT calculator.
- All previous local modalities of treatment, including radiation and surgery, must have been discontinued at least 4 weeks prior to treatment in this study. Patients may have received prior systemic chemotherapy, hormonal therapy, biologic or vaccine therapy
- Patients receiving intermittent hormonal therapy for their rising PSA state are considered eligible if testosterone level is above 150ng/dl and treatment was discontinued > 6 months and agree not to have additional injections while on study drug.
- No history of or current clinical or radiological evidence of distant metastases (excluding prostascint scan/PET in absence of radiographic disease in Bone scan, CT scan or MRI if used). Retroperitoneal/pelvic lymph node up to 2 cm size is allowed for the study.
- ECOG performance score < 2 within 14 days before being registered for protocol therapy
Normal organ function with acceptable initial laboratory values:
- Absolute neutrophil count ≥ 1 x 109/L
- Platelets > 50 x 109/L
- Creatinine <2 mg/dL
- Bilirubin <1.5 X ULN (institutional upper limits of normal)
- AST (SGOT) and ALT (SGPT) ≤ 1.5 x ULN
- Willingness to use adequate methods of contraception throughout study participation and for at least 3 months after completing therapy
Exclusion Criteria:
- Metastatic disease or currently active second malignancy
- History of alcohol dependence, seizures or psychoses.
- Medical conditions such as uncontrolled hypertension, uncontrolled diabetes mellitus, cardiac disease, active infectious hepatitis, type A, B or C, hypothyroidism, which would, in the opinion of the investigator, make this protocol unreasonably hazardous
- Major thoracic or abdominal surgery within the prior 3 weeks. Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
- Use of any prohibited concomitant medications: Metronidazole, Amprenavir, Paraldehyde, Phenytoin, Coumadin, alcohol or alcohol-containing preparations, Isoniazid, Amitriptyline (please see Appendix B for other potential drug-drug interactions). The washout period is at least 2 weeks before starting the study
- Insufficient time from last prior regimen or radiation exposure: Systemic therapies for prostate cancer within 28 days prior to disulfiram; strontium-89 within 12 weeks; bicalutamide within 6 weeks.
- Persistent Grade >2 treatment-related toxicity from prior therapy
- History of any disulfiram-related or drug induced anaphylactic reaction
- Receipt of another investigational agent within 28 days of study entry. Patient must have recovered from all side effects of prior investigational therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Subjects With a Demethylation Response at Each Dose Level
Time Frame: 24 months
|
For both of the doses explored (i.e.
disulfiram 250 mg PO daily and 500 mg PO daily) the proportion of subjects with a demethylation response was computed.
A demethylation response was defined as a >=10% decrease from baseline in global 5-methyl cytosine content as assessed from peripheral blood mononuclear cells.
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Response
Time Frame: Up to 6 months
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To assess the clinical response measured by prostate specific antigen (PSA) progression at 6 months after treatment with the defined dose of disulfiram in prostate cancer (PCa) patients with evidence of biochemical relapse after local therapy. Reported as number of participants with PSA progression by 6 months. Criteria used to assess: A rise in PSA noted at 6 months, greater than 50% over PSA value at baseline and > 2 ng/ml, above the nadir. The rise was confirmed by a second PSA value obtained at least 1 week from that reference value. |
Up to 6 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- J0972
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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