N/A
N=19
Study of Recurrent Prostate Cancer With Rising Prostate Specific Antigen (PSA)
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01118741 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Proportion of Subjects With a Demethylation Response at Each Dose Level — .22; .30 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Disulfiram (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With a Demethylation Response at Each Dose Level |
.22; .30 | — |
| SECONDARY Clinical Response |
5; 0 | — |
Summary
disulfiram is a DNA methyltransferase inhibitor that may provide benefit for patients with prostate cancer by restoring tumor suppressor genes.
Eligibility Criteria
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 50 x 109/L
- Creatinine 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
Data sourced from ClinicalTrials.gov (NCT01118741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.