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).
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 measure
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 (if study stopped)
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
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
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. Repository: 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
Basic results (scientific)
Publication list
2013 meeting abstract in: http://www.ncbi.nlm.nih.gov/pubmed/28136068
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