Conditions: Prostate Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1
Healthy volunteers: no

Brief 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

Detailed description:
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

Arms:
arm 1: Mitotane will be administered on an outpatient or inpatient basis.

Interventions: intervention 1: Mitotane
Intervention descriptions: intervention 1: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily

Protocol document: