Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer

Phase 3 Completed 306 enrolled M.D. Anderson Cancer Center National Cancer Institute (NCI) · collab

RandomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.

Timeline

Start: 1996-08
Primary completion: 2005-06
Completion: 2005-06

Outcome

Missed primary endpoint

paper 35 months (95% CI, 26 to 44 months) in the chemohormonal group (P = .39). PMID 19029421 ↗

Publications

Results Millikan RE, Wen S, Pagliaro LC, Brown MA, Moomey B, Do KA, Logothetis CJ. Phase III trial of androgen ablation with or without three cycles of systemic chemotherapy for advanced prostate cancer. J Clin Oncol. 2008 Dec 20;26(36):5936-42. doi: 10.1200/JCO.2007.15.9830. Epub 2008 Nov 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bicalutamide	Other / unclassified	—	—
Subject	Doxorubicin	Other / unclassified	—	—
Subject	Flutamide	Small molecule	—	—
Subject	Ketoconazole	Small molecule	—	—
Subject	Nilutamide	Small molecule	—	—
Subject	Vinblastine	Small molecule	—	—
Subject	estramustine	Other / unclassified	—	—
Background	therapeutic hydrocortisone	Unknown	—	—