A Randomized, Phase Ii Study Of Repeated Rhenium188-Hedp (Rhenium) Combined With Docetaxel Versus Docetaxel Alone In Castration Resistant Prostate Cancer (Crpc) Metastatic To Bone: The Taxium Ii Trial.

5081Background: Docetaxel is first line chemotherapy in CRPC. Re-188 is a beta-emitting radiopharmaceutical that targets bone metastases. We investigated whether treatment with docetaxel plus Re-188 improved efficacy of first line chemotherapy. Methods: Patients with progressive CRPC and osteoblastic bone metastases were randomized for first line docetaxel 75 mg/m2 3-weekly plus prednisone with or without 2 injections of Re-188 after the 3rd (40 MBq/kg) and after the 6th (20 MBq/kg) cycle of docetaxel. Primary endpoint was progression free survival (PFS), a composite endpoint of either PSA, radiographic or clinical progression. 88 men were included to detect a targeted improvement of PFS at 6 months from 60% in the control group to 75% in the experimental group (power 77%; one-sided significance level 0.05; considered drop-out rate 10%). Patients were stratified by extent of bone metastases and hospital. Results: 42 patients received standard treatment and 46 patients combination therapy. Median number of...