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

Completed · Not applicable

Conditions studied: Prostate Cancer

In brief

disulfiram is a DNA methyltransferase inhibitor that may provide benefit for patients with prostate cancer by restoring tumor suppressor genes.

Key facts

Study ID

NCT01118741

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

19

Starts

2010-05-01

Expected to finish

2012-06-01

Last updated by the study team

2018-06-12

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Duke University — Durham, North Carolina, United States
• Thomas Jefferson Universith — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.