OC-0049: Phase I/II Study of Palliative Radiation and Sorafenib for Metastatic Enal Cell Carcinoma and Bone Metastases

Purpose/Objective: We studied the effect of a higher dose on tumor control for localized prostate cancer in a randomized trial with a median follow-up of 110 months.Materials and Methods: Patients with T1b-T4 prostate cancer were included in the period 1997-2003 (n=664) and randomized between 78 Gy (n=333) and 68 Gy (n=331).Primary endpoint was biochemical and/or clinical failure (BCF) according the guidelines of the American Society for Therapeutic Radiology and Oncology (ASTRO) (3 consecutive rises).Secondary endpoints were BCF using the Phoenix guidelines (nadir plus 2 µg/L), clinical failure (CF), local failure (LF), prostate cancer related death (PCRD), and overall survival (OS).Explorative subgroup analyses were performed.Results: Estimated freedom from BCF at 10 years according ASTRO was 45.9 % and 38.4 % for 78 Gy and 68 Gy, respectively (Log Rank, p=0.025).Freedom from BCF according Phoenix definition (Table ) was superior in the 78 Gy arm as well (p=0.046).CF and OS were similar in both arms (Table ).LF as a first event was significantly less observed in the 78 Gy arm (14 versus 27 events, p=0.036,Figure).For progression outside the prostate, i.e. documented regional or distant failure, we found more first events in the 78 Gy arm, which was not significant (59 versus 43 events, p=0.14).At the current update, 205 patients were deceased (104 in the 78 Gy arm), including 88 patients with