Condition category
Cancer
Date applied
24/08/2005
Date assigned
08/09/2005
Last edited
14/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Nicholas James

ORCID ID

Contact details

Department of Clinical Oncology
University of Birmingham
Institute for Cancer Studies
Vincent Drive
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 4144097
N.D.James@bham.ac.uk

Additional identifiers

EudraCT number

2004-002295-41

ClinicalTrials.gov number

NCT00554918

Protocol/serial number

HTA 06/303/205; PR2100

Study information

Scientific title

A randomised phase III trial of docetaxel plus prednisolone vs docetaxel with prednisolone plus either zoledronic acid, strontium-89 or both agents combined (TRAPEZE)

Acronym

TRAPEZE

Study hypothesis

Study aim: To compare the efficacy and safety of the four clinical trial arms in the treatment of hormone refractory prostate cancer (HRPC0 patients).

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/06303205
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0015/51324/PRO-06-303-205.pdf

Ethics approval

South West Research Ethics Committee, 09/11/2004, ref: 04/MRE06/48

Study design

Phase III randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information sheet can be found at http://www.trapeze.bham.ac.uk/documents/TRAPEZE_PatientInfo-v2.pdf

Condition

Prostate cancer

Intervention

Current interventions as of 15/01/2009:
1. Docetaxel (Taxotere®) 75 mg/m2 as a one hour intravenous infusion every 3 weeks for a maximum of 6 cycles.
2. Docetaxel (Taxotere®) as a one hour intravenous infusion every 3 weeks for a maximum of 6 cycles with Zoledronic acid (Zometa®) every 3 weeks. Zoledronic acid will then continue alone every 4 weeks until you or your doctor wishes to discontinue it.
3. Docetaxel (Taxotere®) as a one hour intravenous infusion every 3 weeks for a maximum of 6 cycles and one treatment of Strontium-89 given 28 days after the last dose of Docetaxel (Taxotere) as a short intravenous injection.
4. Docetaxel (Taxotere®) as a one hour intravenous infusion every 3 weeks for a maximum of 6 cycles, followed by one treatment of Strontium-89 given 28 days later. Zoledronic acid (Zometa®) will be given every 3 weeks throughout the treatment. Zoledronic acid will then continue alone every 4 weeks until you or your doctor wishes to discontinue it.

As part of the main treatment the participants will also be given steroid tablets (prednisolone) to take during the course of treatment with docetaxel. In addition they will receive extra steroid tablets (dexamethasone) for a few days around each infusion of chemotherapy to decrease the potential side effects of docetaxel (allergic reactions and fluid retention).

Previous interventions:
A randomised phase II feasibility study of Docetaxel (Taxotere) plus Prednisolone versus Docetaxel (Taxotere) plus Prednisolone plus Zoledronic acid (Zometa) versus Docetaxel (Taxotere) plus Prednisolone plus Strontium-89 versus Docetaxel (Taxotere) plus Prednisolone plus Zoledronic acid (Zometa) plus Strontium-89 in Hormone Refractory Prostate Cancer metastatic to bone

Intervention type

Drug

Phase

Phase III

Drug names

Docetaxel (Taxotere®), prednisolone, zoledronic acid (Zometa®), strontium-89

Primary outcome measures

Current primary outcome measures as of 15/01/2009:
The following will be assessed every month for the first three months and then every three months until death:
1. Toxicity and tolerability of docetaxel + synchronous zoledronic acid (Zometa®)
2. Toxicity and tolerability of docetaxel + sr-89
3. Toxicity and tolerability of docetaxel + synchronous zoledronic acid (Zometa®) + Sr-89

Previous primary outcome measures:
1. Toxicity and Tolerablity of Docetaxel + Synchronous Zoledronic acid (Zometa)
2. Toxicity and tolerablity of Docetaxel + Sr-89
3. Toxicity and tolerablity of Docetaxel + synchronous Zoledronic acid (Zometa) + Sr-89

Secondary outcome measures

1. Health care economic analysis
2. Changes in bone mineral density
3. Biological profiling for prognostic and predictive indicators

Overall trial start date

01/04/2007

Overall trial end date

01/03/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age >18 years
2. Histologically/cytologically proven prostate cancer or multiple sclerotic bone metastases with prostate specific antigen (PSA) >100 ng/ml without histological confirmation
3. Radiological evidence of bone metastatsis
4. Prior hormonal therapy for prostate cancer, resulting in serum testosterone <50 ng/dl: bilateral orchidectomy, and/or medical castration by LHRH agonist therapy
5. Documented disease progression, defined by one of the following: elevated PSA (progressive rise) and/or progression of any unidemensionally or bidimensionally measurable malignant lesion at least one new lesion identified on bone scan
7. Life expectancy >3 months
8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
9. Adequate haematological function
10. Adequate renal and hepatic function
11. Written Informed Consent

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

618 split into 4 groups

Participant exclusion criteria

1. Prior cytotoxic chemotherapy for HRPC, other than estramustine monotherapy
2. Prior radiotherapy to more than 25% of the bone marrow or whole pelvic irradiation
3. Prior radionuclide therapy for HRPC
4. Prior tretament with a bisphosphonate for any reason within previous 2 months
5. Malignant disease within the previous 5 years, other than adequatly treated basal cell carcinoma
6. Known brain or leptomeningeal metastases
7. Symptomatic peripheral neuropathy >grade 2 (NCI CTC)
8. Known hypersensitivity to bisphosphonates
9. Concurrent enrolment in any other investigational clinical trial
10. Treatment with any other investigational compound within previous 30 days
11. Any condition, which, in the opion of the investigator, might interfere with the safety or evaluation of the study objectives

Recruitment start date

01/04/2007

Recruitment end date

19/07/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom

Trial participating centre

Edinburgh Cancer Centre
Western General Hospital Crewe Road
Edinburgh
EH4 2XU
United Kingdom

Trial participating centre

Christie Hospital NHS Trust
Wilmslow Road
Manchester
M20 4BX
United Kingdom

Trial participating centre

The Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom

Trial participating centre

The Royal Marsden Hospital
Fulham Road Chelsea
London
SW3 6JJ
United Kingdom

Trial participating centre

Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

Trial participating centre

Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom

Trial participating centre

Wishaw General Hospital
50 Netherton Street
Wishaw
ML2 0DP
United Kingdom

Trial participating centre

Cheltenham General Hospital
Sandford Road
Cheltenham
GL53 7AN
United Kingdom

Trial participating centre

Gloucester Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom

Trial participating centre

University Hospital Ayr
Dalmellington Road
Ayr
KA6 6DX
United Kingdom

Trial participating centre

Ipswich Hospital
Heath Road
Ipswich
IP4 5PD
United Kingdom

Trial participating centre

Queen Alexandra Hospital
Cosham
Portsmouth
PO6 3LY
United Kingdom

Trial participating centre

Velindre Hospital
Velindre Road Whitchurch
Cardiff
CF14 2TL
United Kingdom

Trial participating centre

Maidstone Hospital
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom

Trial participating centre

St James’ University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom

Trial participating centre

Royal Albert Edward Infirmary
Wigan Lane
Wigan
WN1 2NN
United Kingdom

Trial participating centre

Southampton University Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Weston General Hospital
Grange Road
Weston-super-Mare
BS23 4TQ
United Kingdom

Trial participating centre

Dorset County Hospital
Williams Avenue
Dorchester
DT1 2JY
United Kingdom

Trial participating centre

Forth Valley Royal Hospital
Stirling Road
Larbert
FK5 4WR
United Kingdom

Trial participating centre

Royal Bournemouth Hospital
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom

Trial participating centre

Poole Hospital
Longfleet Road
Poole
BH15 2JB
United Kingdom

Trial participating centre

Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom

Trial participating centre

Huddersfield Royal Infirmary
Lindley
Huddersfield
HD3 3EA
United Kingdom

Trial participating centre

Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Trial participating centre

Royal Preston Hospital
Sharoe Green Lane Fulwood
Preston
PR2 9HT
United Kingdom

Trial participating centre

Calderdale Royal Hospital
Salterhebble
Halifax
HX3 0PW
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

http://www.bham.ac.uk

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The primary outcome results and health economic results of the trial were submitted for publication in peer-reviewed journals, and the full trial results submitted for peer review and publication to the NIHR (UK). Published results were disseminated to investigators at participating sites, who will further disseminate the results to trial participants on request.

Secondary publications and presentations must be reviewed and authorised by the Trial’s Steering Committee. Please contact the TRAPEZE trial office for further information at TRAPEZE@trials.bham.ac.uk.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study will be stored in a publically available repository.
Respository: European Medicines Agency (EMA)’s European Clinical Trials Database, EudraCT V10.
URL : https://eudract.ema.europa.eu/

Intention to publish date

01/06/2016

Participant level data

Stored in repository

Results - basic reporting

Publication summary

2013 meeting abstract in http://meeting.ascopubs.org/cgi/content/abstract/31/18_suppl/LBA5000
2016 results in http://www.ncbi.nlm.nih.gov/pubmed/26794729
2016 results in http://www.ncbi.nlm.nih.gov/pubmed/27256016
2016 results in http://www.ncbi.nlm.nih.gov/pubmed/27434595

Publication citations

Additional files

Editorial Notes

14/11/2016: The trial participating centres have been added. 11/11/2016: The overall trial end date has been updated from 29/02/2012 to 01/03/2016 and the recruitment end date has been updated from 29/02/2012 to 19/07/2016. In addition, the publication and dissemination plan and availability of participant level data has been added. 21/07/2016: Publication reference added. 06/06/2016: Publication reference added. 25/01/2016: Publication reference added. 16/02/2012: The following changes were made to the trial record: 1. The target number of participants was reduced from 1240 to 618 evaluable patients, due to a revised statistical analysis plan as per Protocol V10. 2. The study design was changed from 'Phase III randomised controlled feasibility trial' to 'Phase III randomised controlled trial'. 3. The overall trial end date was changed from 28/02/2013 to 29/02/2012. 15/02/2011: the target number of participants was changed from 300 to 1240 split into 4 groups. 10/01/2008: the following changes were made to the trial record: 1. The public title was changed from "A randomised phase II feasibility study of Docetaxel (Taxotere) plus Prednisolone versus Docetaxel (Taxotere) plus Prednisolone plus Zoledronic acid (Zometa) versus Docetaxel (Taxotere) plus Prednisolone plus Strontium-89 versus Docetaxel (Taxotere) plus Prednisolone plus Zoledronic acid (Zometa) plus Strontium-89 in Hormone Refractory Prostate Cancer metastatic to bone" to "A randomised phase III trial of docetaxel plus prednisolone vs docetaxel with prednisolone plus either zoledronic acid, strontium-89 or both agents combined (TRAPEZE)." 2. The overall trial start and end dates were changed from 01/01/2005 and 01/01/2009 to 01/04/2007 and 28/02/2013, respectively.