Randomized Phase III Trial Comparing Cabazitaxel Combination Hormone Therapy to Hormone Therapy Alone in Metastatic Prostate Cancer or High Risk Disease (SensiCab)

NCT01978873 Phase 3 UNKNOWN

This clinical trial is designed on the basis of an unmet clinical need, as well as other factors including: 1) the ability to identify subjects at high risk of dying early from their disease, 2) the fact that hormonal therapy has already been shown to improve survival when applied early in the natural history, 3) the availability of chemotherapy such as cabazitaxel that can improve survival in subjects with advanced disease and 4) that chemotherapy (docetaxel) given concomitant with hormone treatment has proven to prolong time to progression. It is the investigators hypothesis that a more appropriate group of patients who may benefit from the curative potential of systemic chemo-hormonal modality is that with minimal, but detectable disease who have a high probability of developing metastatic disease, clinical symptoms and eventually death from prostate cancer in a defined time frame. The investigators hypothesize further that the approach is likely to be more effective at a time of minimal tumour burden, resulting in minimization of the overall burden of therapy and better quality of life while on treatment. This trial will determine whether any benefit is gained by adding chemotherapy before hormonal therapy to hormonal therapy alone in the population of subjects with metastatic or high risk disease.

Details

Lead sponsor	Örebro University, Sweden
Phase	Phase 3
Status	UNKNOWN
Enrolment	400
Start date	2012-11
Completion	2019-11

Conditions

• Prostate Cancer

Interventions

• Cabazitaxel + Androgen deprivation therapy
• Androgen deprivation therapy

Primary outcomes

• Overall survival — From date of randomization until date of death from any cause, assessed up to 7 years.

Countries

Sweden