Prostate Cancer Clinical Trial
Official title:
Randomized Phase III Trial Comparing Cabazitaxel Combination Hormone Therapy to Hormone Therapy Alone in Metastatic Prostate Cancer or High Risk Disease
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.
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. Two therapeutic approaches will be compared in this two-arm randomized
clinical trial. The control Arm A provides hormonal therapy alone. The experimental Arm B
involves treatment with hormone therapy + Cabazitaxel 25 mg / m² / day on day 1 every 3
weeks continued if the patient has stable or responding disease up to 10 cycles. For the
schematic representation of study design please see Section 7.3.1.
Subjects with primary metastatic or N+ or high risk disease (PSA>100) will be eligible. The
primary endpoint of the trial is overall survival.
Based on the yearly number of prostate cancer patients who are diagnosed with metastatic or
high risk disease, approximately 1200 men per year (if +15% improvement)are potential
candidates for this approach in the Scandinavian countries .
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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