A trial evaluating cabazitaxel versus docetaxel rechallenge for the treatment of metastatic castrate refractory prostate cancer, previously treated with docetaxel at inception of primary hormone therapy
| ISRCTN | ISRCTN16465571 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16465571 |
| Clinical Trials Information System (CTIS) | 2012-003835-40 |
| Protocol serial number | 13741 |
| Sponsor | University of Birmingham (UK) |
| Funders | Aventis Pharma Ltd T/A Sanofi-Aventis, Cancer Research UK (UK) |
- Submission date
- 26/03/2013
- Registration date
- 26/03/2013
- Last edited
- 21/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Mr Nick Martin
Scientific
Scientific
Cancer Research UK Clinical Trials Unit
Institute for Cancer Studies
Edgbaston
Birmingham
B15 2TT
United Kingdom
| CANTATA@trials.bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A multicentre, phase II randomised controlled trial evaluating cabazitaxel versus docetaxel rechallenge for the treatment of metastatic castrate refractory prostate cancer, previously treated with docetaxel at inception of primary hormone therapy |
| Study acronym | CANTATA |
| Study objectives | This study compares the safety and levels of activity of cabazitaxel versus docetaxel re-challenge in patients with metastatic castrate refractory prostate cancer who have been previously exposed to combined docetaxel and androgen deprivation as first-line treatment for advanced prostate cancer. The difference between treatment arms in terms of the number of patients who have a clinical event (clinical progression or death) will provide the evidence whether the levels of activity of cabazitaxel warrant further investigation in a phase III trial. |
| Ethics approval(s) | Liverpool Central - North West NRES Committee, 10/12/2012, ref: 12/NW/0792 |
| Health condition(s) or problem(s) studied | Prostate cancer |
| Intervention | Patients will be randomised to one of the following two treatments (plus 10mg prednisolone daily in either regimen): 1. Cabazitaxel 25mg/m2 3 weekly plus prednisolone for up to 10 cycles 2. Docetaxel 75mg/m2 3 weekly plus prednisolone for up to 10 cycles Follow Up Length: 24 month(s) |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Cabazitaxel, docetaxel |
| Primary outcome measure(s) |
Clinical progression-free survival (CPFS) |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 29/04/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 138 |
| Total final enrolment | 15 |
| Key inclusion criteria | 1. Diagnosis of histologically proven prostate adenocarcinoma, that is castrate refractory 2. Previously treated with up to 6 cycles of Docetaxel at the same time (defined as commencing within 3 months) as instigation of primary hormone therapy. 3. Confirmed biochemical, radiological or clinical progression. 4. Metastatic disease 5. Male and female, aged 18 or over 6. WHO performance status grade 0 to 2 7. Adequate organ function as evidenced by: 7.1. ANC >1.5 x109/L 7.2. WBC >3.0 x109/L 7.3. Haemoglobin >10g/dL 7.4. Platelet count > 100 x10^9L 7.5. Total bilirubin <1.0 xULN 7.6. AST/ ALT <1.5 xULN 7.7. GFR >30ml/min (calculated by EDTA clearance, 24h urine collection, or Cockcroft-Gault) 8. Available for long-term follow up 9. Patients written informed consent |
| Key exclusion criteria | 1. Prior systemic therapy with other chemotherapy drugs 2. Metastatic brain disease or leptomeningeal disease 3. Patients with bilirubin equal to or greater than 1.0 xULN 4. Previous extensive palliative radiotherapy to bone marrow, e.g. hemibody radiotherapy 5. Active grade >=2 peripheral neuropathy (NCI CTC v 4) 6. Active infection requiring systemic antibiotic or antifungal medication 7. Patients with reproductive potential not implementing accepted and effective method of contraception |
| Date of first enrolment | 07/03/2013 |
| Date of final enrolment | 12/01/2016 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom
Birmingham
B15 2TH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository in 2017. Repository : European Medicines Agency (EMA)’s European Clinical Trial Database, EudraCT V10. URL : http://eudract.ema.europa.eu |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 21/06/2019 | No | No | ||
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/06/2019: Added clinicaltrialsregister.eu link to basic results (scientific). Added total final enrollment.
20/02/2017: The overall trial end date was changed from 12/02/2016 to 29/04/2016.
14/11/2016: The overall trial end date was changed from 30/06/2015 to 12/02/2016.
