This phase 3 study involved non-castrate (hormone-sensitive) prostate cancer patients who were divided into two separate treatment groups. Group A consisted of 192 men with a median age of 63 years. Group B had 193 men with a median age of 64 years.
Patients in group A were treated with androgen-deprivation therapy (hormone therapy) and the chemotherapy agent docetaxel.
Patients in group B were treated with androgen-deprivation therapy (hormone therapy) alone.
There were four treatment-related deaths in group A. Causes of death included neutropenia and infection. Grade 3-4 fatigue and erectile dysfunction were also reported.
The most severe toxicities were of grade 4 and included grade 3-4 erectile dysfunction and decreased libido.
The median overall survival for groups A and B was 58.9 and 54.2 months, respectively.
This study was partially supported by Sanofi-Aventis, Amgen, and AstaZeneca.
Correspondence: Dr. Gwenaelle Gravis; email: firstname.lastname@example.org