Efficacy Study Evaluating Chemotherapy in Prostate Cancer
Status:
Unknown status
Trial end date:
2019-11-01
Target enrollment:
Participant gender:
Summary
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.