A Safety and Feasibility Study of Mitotane in Prostate Cancer

Official Title

A Safety and Feasibility Study of Mitotane in Prostate Cancer

Summary:

1. The primary objective of this study is to assess the feasibility of treating patients with metastatic castration resistant prostate cancer with mitotane. Secondary objectives are to assess safety and tolerability as well as response rate of therapy 2. To assess the toxicity of Mitotane in men with HRPC 3. To assess the relationship between baseline serum adrenal androgens and their response to Mitotane

Trial Description

Primary Outcome:

• The Primary Endpoint is the Proportion of Patients Maintained on Mitotane After 12 Consecutive Weeks of Therapy. A Positive Outcome Would be Seeing 50% or More Patients Maintained on Therapy. Secondary Endpoint Include Proportion of Adverse Events

Secondary Outcome:

• Prostate Specific Antigen (PSA) Response Rate

All patients will undergo pre-study assessment for symptoms, performance status, ECG, CT abdomen/pelvis, Bone scan, Complete blood count tests(hematology) , Biochemistry tests like serum electrolytes, liver function tests, coagulation profile, testosterone and PSA tests. Mitotane will be administered 1.5g daily escalation to maximum of 5 g daily then adjusted according to serum levels and tolerability Physical examinations, hematology, biochemistry tests, and toxicity evaluations will be measured throughout patients on protocol treatment Mitotane serum level will be analyzed every second cycle Research bloods include; ACTH, cortisol, deoxycorticosterone, aldosterone, corticosterone, and testosterone, androstenedione, dehydroepiandrostenedione (DHEA), DHEA sulfate (DHEA-S) and estradiol will be collected only in cycle 1,3 and 5

View this trial on ClinicalTrials.gov