GETUG-AFU 23 UC-0160/1202
Research type
Research Study
Full title
A randomized Phase III, factorial design, of cabazitaxel and pelvic radiotherapy in patients with localized prostate cancer and high-risk features of relapse
IRAS ID
166274
Contact name
Beata JUZYNA
Contact email
Sponsor organisation
UNICANCER
Eudract number
2012-000566-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
13 years, 4 months, 30 days
Research summary
Although prostate cancer-related death is almost systematically due to metastatic dissemination, most patients who are diagnosed with prostate cancer nowadays have localized disease at presentation. There is now strong evidence that combining androgen deprivation therapy (ADT) with radiotherapy improves the survival of patients with high-risk localized prostate cancer.
This trial, which will include over 1000 patients, aims to evaluate the efficacy of neoadjuvant chemotherapy with cabazitaxel and that of pelvic radiotherapy in combination with hormone therapy in patients at very high risk of relapse.
The trial is a multicenter, international, randomized Phase III, factorial design, open trial in 2 phases:
A feasibility phase (first 200 patients): during this phase, an Independent Data Monitoring Committee (IDMC) will meet after 20 and 50 patients have been included in each arm to evaluate the tolerability of neoadjuvant cabazitaxel in this population.
Depending on the results of this feasibility phase and of any new relevant clinical results in such a population, the remaining patients (n=848) will be enrolled.REC name
London - Fulham Research Ethics Committee
REC reference
16/LO/1587
Date of REC Opinion
15 Dec 2016
REC opinion
Further Information Favourable Opinion