The STAMPEDE prostate cancer trial has launched protocol version 8.0, bringing in a novel research arm to which patients could be allocated. The new arm, G, involves Hormone Therapy in combination with abiraterone, and was formally activated on Tuesday 15 November 2011.
Abiraterone is a CYP17 inhibitor manufactured by Janssen. Previous results in castrate-refractory prostate cancer have shown very promising results. STAMPEDE recruits in an earlier setting: high-risk patients starting long-term hormone therapy for the first time. Professor Johann de Bono, Chief Investigator of the previous trials of abiraterone in castrate-refractory prostate cancer, has described the addition of the abiraterone arm to STAMPEDE as "a major day in prostate cancer history".
STAMPEDE, which implements novel multi-arm multi-stage (MAMS) methods, is recruiting around 65 patients each month; over 2600 patients had joined the trial by the end of October 2011.
At present, the trial is recruiting to four research arms and the control arm. Discussions are ongoing with regards to further possible research arms.
A further change in protocol version 8.0 relates to the inclusion of radiotherapy for all patients with newly diagnosed node-negative, non-metastatic disease. The change follows the results of MRC PR07 (NCIC PR.3), which were published in The Lancet earlier this month.
More information can be found on the STAMPEDE website and any questions should be directed to the STAMPEDE team: firstname.lastname@example.org