Metastatic Castration Resistant Prostate Cancer
Conditions
Keywords
Prostate Cancer, Metastatic, Castration Resistant
Brief summary
Cabazitaxel has shown significant efficacy as second line chemotherapy after Docetaxel in men with metastatic castration resistant prostate cancer. This was demonstrated in the Tropic Study where Cabazitaxel showed survival superiority compared to mitoxantrone. Almost one in 4 patients treated with Cabazitaxel in this study required dose reductions or dose delays or stopped treatment due to toxicity. ConCab examines another scheduling for cabazitaxel to see if we can improve tolerability so that patients will receive a higher percentage of the treatment as planned.
Detailed description
ConCab compares the standard treatment of cabazitaxel 25 mg/m2 every three weeks with an experimental scheduling of 10 mg/m2 for 5 consecutive weeks of a 6 week cycle. In both study arms the planned cumulative dose of cabazitaxel at week 18 is 150 mg/m2. Our study aims to evaluate differences in the total received dose in relation to the planned dose as a measure of which of the 2 treatment schedules is superior.
Interventions
DRUGCabazitaxel
25 mg/m2 every three weeks
DRUGweekly cabazitaxel
10 mg/m2 dag 1,8,15,22. Cycle length is 6 weeks
Sponsors
Sanofi
Jeffrey Yachnin M.D., PhD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
¨ * Histological confirmed prostate cancer * Macroscopic metastatic disease * Prior treatment with Docetaxel * Castration resistant disease defined as:Serum testosterone (\< 0.5 ng/ml) and: * Increase in measurable disease (RECIST 1.1, see appendix 10) or * For non-measurable disease, the appearance of at least one new lesion on nuclear scintigraphy) or * A rising PSA from the previous reference value on 2 consecutive occasions at least one week apart * Written informed consent
Exclusion criteria
* Less than 21 days since prior treatment with chemotherapy * Less than 14 days since radiotherapy or surgery to the start of cabazitaxel - Less than 4 weeks after stopping endocrine therapies including antiandrogen, abiraterone or other new agents. * Prior isotope therapy or radiotherapy to \> 30% of bone marrow (whole pelvic radiotherapy is not an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative cumulative dose of cabazitaxel at week 18 | week 18 after start of treatment | The primary endpoint compares the cumulative dose of cabazitaxel that is received relative to the planned dose at 18 weeks of therapy. The cumulative dose of cabazitaxel in relation to the expected dose is a reflection of both tolerability and efficacy. Patients stopping treatment due to disease progression prior to week 18 will have lower relative cumulative doses as will patients with poor tolerability due to dose reductions and delays. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | when the last enrolled patient has completed 18 weeks of therapy or has stopped therapy at an earlier date | Overall survival is defined as the length of time from randomization to death from any cause |
| Progression free survival | when the last enrolled patient has completed 18 weeks of therapy or has stopped therapy at an earlier date | Progression free survival is defined as the length of time from randomisation to the first documentation of one of the following: PSA progression or pain progression or death due to any cause or radiological disease progression |
| PSA Response | when the last enrolled patient has completed 18 weeks of therapy or has stopped therapy at an earlier date | Only considered after 12 weeks of treatment. PSA response is defined as a 50% or greater decline in serum PSA from baseline given that baseline PSA is at least 10 ng/ml |
Countries
Sweden
Outcome results
None listed