Overview

Antiandrogen Withdrawal in Treating Patients With Hormone-Refractory Prostate Cancer

Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
0
Participant gender:
Male
Summary
RATIONALE: Antiandrogen withdrawal may be an effective treatment for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of ketoconazole and hydrocortisone for antiandrogen withdrawal in treating men with prostate cancer that is refractory to hormone therapy.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborator:
National Cancer Institute (NCI)
Treatments:
Androgen Antagonists
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Ketoconazole
Criteria
DISEASE CHARACTERISTICS: Histologically diagnosed adenocarcinoma of the prostate
Progressive metastatic or regional nodal disease after at least 4 weeks on flutamide,
bicalutamide, or nilutamide, i.e.: Greater than 25% increase in sum of products of
perpendicular diameters of all measurable lesions not previously irradiated OR
Prostate-specific antigen (PSA) at least 5 ng/mL and risen from baseline on at least 2
successive occasions at least 2 weeks apart PSA progression required for "bone only"
disease or disease that responded to androgen deprivation and is negative on imaging scans
at entry Primary testicular androgen suppression with a luteinizing hormone-releasing
hormone (LHRH) analogue plus antiandrogen or by orchiectomy required Intermittent LHRH
analog/antiandrogen therapy resumed at least 4 weeks prior to and continued at time of
entry LHRH analogue continued throughout study in absence of orchiectomy

PATIENT CHARACTERISTICS: Age: Any age Performance status: 0-2 Hematopoietic: Not specified
Hepatic: Bilirubin no greater than 1.5 times normal AST no greater than 3 times normal
Renal: Not specified Other: No active, uncontrolled condition including: Bacterial, viral,
or fungal infection Hyperglycemia Gastric or duodenal ulcer No existing medical condition
requiring systemic corticosteroids (inhaled and topical steroids allowed) No concurrent use
of the following: Terfenadine Astemizole Cisapride

PRIOR CONCURRENT THERAPY: No prior therapy with experimental agents for metastatic disease
Biologic therapy: No prior immunotherapy for metastatic disease Chemotherapy: No prior
estramustine or other chemotherapy for metastatic disease Endocrine therapy: See Disease
Characteristics No prior hormonal therapy for metastatic disease No prior aminoglutethimide
No prior ketoconazole No prior hydrocortisone or other corticosteroids Prior experimental
hormonal therapy requires approval of study chair Radiotherapy: At least 4 weeks since
radiotherapy (8 weeks since strontium therapy) Surgery: Orchiectomy allowed