Phase 3 study of Lenalidomide in castrate-resitant prostate cancer

• Research type

  Research Study

• Full title

  A PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF DOCETAXEL AND PREDNISONE WITH OR WITHOUT LENALIDOMIDE IN SUBJECTS WITH CASTRATE-RESISTANT PROSTATE CANCER

• IRAS ID

  31060

• Contact name

  David Paul Dearnaley

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2008-007969-23

• ISRCTN Number

  Not Submitted

• Research summary

  This is a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group efficacy and safety study in chemo-naive subjects with metastatic Castrate Resistant Prostate Cancer (CRPC) with documented progressive disease as determined by rising PSA levels or radiological progression following hormonal therapy. Approximately 1015 subjects meeting inclusion criteria will be randomized 1:1 into one of two treatment arms: ?½ DP Treatment Arm: docetaxel, prednisone and placebo?½ DPL Treatment Arm: docetaxel, prednisone and lenalidomide Subjects will begin their initial study treatment (Cycle 1, Day 1) within 3 days of randomization. Study treatment will continue until subjects experience disease progression, except bone lesions, or premature discontinuation for any other reason. Discontinuation for bone progression will require = 2 new lesions with confirmation during the next scheduled tumor assessment (9 weeks after initial observation of = 2 new lesions). PSA progression is not considered disease progression and does not mandate discontinuation from the Treatment Phase of the study. Subjects will be followed after study treatment discontinuation for survival and additional treatments for prostate cancer every 90 days for up to approximately 5 years.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  09/H0720/132

• Date of REC Opinion

  7 Jan 2010

• REC opinion

  Further Information Favourable Opinion