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
EudraCT/CTIS number	2012-003835-40
Secondary identifying numbers	13741

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

http://www.cancerresearchuk.org/cancer-help/trials/trials-search/a-trial-looking-at-cabazitaxel-for-prostate-cancer-that-has-started-to-get-worse-after-having-hormone-therapy-and-docetaxel-cantata

Contact information

Mr Nick Martin
Scientific

Cancer Research UK Clinical Trials Unit
Institute for Cancer Studies
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	CANTATA@trials.bham.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient 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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Cabazitaxel, docetaxel
Primary outcome measure	Clinical progression-free survival (CPFS)
Secondary outcome measures	No secondary outcome measures
Overall study start date	07/03/2013
Completion date	29/04/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target number of participants	Planned Sample Size: 138; UK Sample Size: 138; Description: Target recruitment is 138 patients in total, with 69 patients per arm.
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

England
United Kingdom

Study participating centre

The Queen Elizabeth Hospital

Edgbaston
Birmingham
B15 2TH
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Website	http://www.birmingham.ac.uk/researchsupportgroup
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Industry

Aventis Pharma Ltd T/A Sanofi-Aventis

No information available

Cancer Research UK (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date	31/12/2017
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	Results of this trial will be submitted for publication in a peer-reviewed journal. The manuscript will be prepared by the Trial Management Group (TMG) and authorship will be determined by mutual agreement.
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

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.