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N/A N=19 Treatment

Study of Recurrent Prostate Cancer With Rising Prostate Specific Antigen (PSA)

Prostate Cancer

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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