Prostate Cancer Clinical Trial
Official title:
A Safety and Feasibility Study of Mitotane in Prostate Cancer
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
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
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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