Phase III trial of androgen ablation with or without three cycles of systemic chemotherapy for advanced prostate cancer.

ABSTRACT:

Purpose

We conducted a phase III trial in patients with previously untreated metastatic prostate cancer to test the hypothesis that three 8-week cycles of ketoconazole and doxorubicin alternating with vinblastine and estramustine, given in addition to standard androgen deprivation, would delay the appearance of castrate-resistant disease.

Patients and methods

Eligible patients had metastatic prostate cancer threatening enough to justify sustained androgen ablation and were fit enough for chemotherapy. The primary end point was time to castrate-resistant progression as shown by increasing prostate-specific antigen, new radiographic lesions, worsening cancer-related symptoms, or receipt of any other systemic therapy.

Results

Three hundred six patients were registered; 2

SUBMITTER: Millikan RE 

PROVIDER: S-EPMC3864402 | biostudies-literature | 2008 Dec

REPOSITORIES: biostudies-literature