Conditions: Prostate Cancer
Keywords: Castrate-Resistant Prostate Cancer Revlimid Lenalidomide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1059
Healthy volunteers: no

Brief summary:
The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer.

The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects.

Detailed description:
In November 2011, the Data Monitoring Committee concluded it was unlikely that the study would meet its primary endpoint of overall survival (OS) and recommended that the study be stopped. The study was terminated in accordance with this recommendation. All sites were instructed to immediately discontinue all patients from experimental lenalidomide/placebo treatment administered either in combination with chemotherapy or as a single agent following chemotherapy discontinuation. Subsequently, Protocol Amendment 3 was issued to provide for the following:

To continue to collect information on Second Primary Malignancies (SPMs) and additional treatments for Prostate Cancer in all randomized subjects during survival follow-up.

To continue to provide docetaxel and prednisone for up to 10 cycles to subjects randomized at non-US sites who were ongoing in the CC-5013-PC-002 protocol when the decision was made to discontinue lenalidomide/placebo and who were experiencing benefit as per investigator discretion. For subjects who had exceeded 10 cycles of docetaxel and prednisone at the time of Protocol Amendment 3 approval, an additional two cycles were provided.

All references to dosing and study procedures pertaining to the safety, efficacy, and exploratory endpoints of lenalidomide/placebo were discontinued as part of Protocol Amendment 3.

Arms:
arm 1: 25 mg lenalidomide orally once each day on Days 1-14; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice daily on each day of the treatment cycle arm 2: Oral placebo once each day on Days 1-14 of the treatment cycle; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice each day on each day of the treatment cycle

Interventions: intervention 1: Lenalidomide intervention 2: Docetaxel intervention 3: Prednisone intervention 4: Placebo
Intervention descriptions: intervention 1: 25 mg lenalidomide orally once each day on Days 1-14 intervention 2: 75 mg/m2 intravenous docetaxel on Day 1 intervention 3: 5 mg prednisone orally twice daily on each day of the treatment cycle intervention 4: Oral placebo once each day on Days 1-14 of the treatment cycle

Protocol document: