A randomised phase III trial of docetaxel plus prednisolone vs docetaxel with prednisolone plus either zoledronic acid, strontium-89 or both agents combined
| ISRCTN | ISRCTN12808747 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12808747 |
| EudraCT/CTIS number | 2004-002295-41 |
| ClinicalTrials.gov number | NCT00554918 |
| Secondary identifying numbers | HTA 06/303/205; PR2100 |
- Submission date
- 24/08/2005
- Registration date
- 08/09/2005
- Last edited
- 24/03/2022
- 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
Prof Nicholas James
Scientific
Scientific
Department of Clinical Oncology
University of Birmingham
Institute for Cancer Studies
Vincent Drive
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 4144097 |
|---|---|
| N.D.James@bham.ac.uk |
Study information
| Study design | Phase III randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information sheet can be found at http://www.trapeze.bham.ac.uk/documents/TRAPEZE_PatientInfo-v2.pdf |
| 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) |
| Study acronym | TRAPEZE |
| Study objectives | 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(s) | South West Research Ethics Committee, 09/11/2004, ref: 04/MRE06/48 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/2007 |
| Completion date | 01/03/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 618 split into 4 groups |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 19/07/2013 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
The Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom
Birmingham
B15 2TH
United Kingdom
Edinburgh Cancer Centre
Western General Hospital
Crewe Road
Edinburgh
EH4 2XU
United Kingdom
Crewe Road
Edinburgh
EH4 2XU
United Kingdom
Christie Hospital NHS Trust
Wilmslow Road
Manchester
M20 4BX
United Kingdom
Manchester
M20 4BX
United Kingdom
The Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
Sutton
SM2 5PT
United Kingdom
The Royal Marsden Hospital
Fulham Road
Chelsea
London
SW3 6JJ
United Kingdom
Chelsea
London
SW3 6JJ
United Kingdom
Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
Glasgow
G12 0YN
United Kingdom
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
Aberdeen
AB25 2ZN
United Kingdom
Wishaw General Hospital
50 Netherton Street
Wishaw
ML2 0DP
United Kingdom
Wishaw
ML2 0DP
United Kingdom
Cheltenham General Hospital
Sandford Road
Cheltenham
GL53 7AN
United Kingdom
Cheltenham
GL53 7AN
United Kingdom
Gloucester Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom
Gloucester
GL1 3NN
United Kingdom
University Hospital Ayr
Dalmellington Road
Ayr
KA6 6DX
United Kingdom
Ayr
KA6 6DX
United Kingdom
Ipswich Hospital
Heath Road
Ipswich
IP4 5PD
United Kingdom
Ipswich
IP4 5PD
United Kingdom
Queen Alexandra Hospital
Cosham
Portsmouth
PO6 3LY
United Kingdom
Portsmouth
PO6 3LY
United Kingdom
Velindre Hospital
Velindre Road
Whitchurch
Cardiff
CF14 2TL
United Kingdom
Whitchurch
Cardiff
CF14 2TL
United Kingdom
Maidstone Hospital
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom
Maidstone
ME16 9QQ
United Kingdom
St James’ University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Leeds
LS9 7TF
United Kingdom
Royal Albert Edward Infirmary
Wigan Lane
Wigan
WN1 2NN
United Kingdom
Wigan
WN1 2NN
United Kingdom
Southampton University Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Southampton
SO16 6YD
United Kingdom
Weston General Hospital
Grange Road
Weston-super-Mare
BS23 4TQ
United Kingdom
Weston-super-Mare
BS23 4TQ
United Kingdom
Dorset County Hospital
Williams Avenue
Dorchester
DT1 2JY
United Kingdom
Dorchester
DT1 2JY
United Kingdom
Forth Valley Royal Hospital
Stirling Road
Larbert
FK5 4WR
United Kingdom
Larbert
FK5 4WR
United Kingdom
Royal Bournemouth Hospital
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom
Bournemouth
BH7 7DW
United Kingdom
Poole Hospital
Longfleet Road
Poole
BH15 2JB
United Kingdom
Poole
BH15 2JB
United Kingdom
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
London
NW3 2QG
United Kingdom
Huddersfield Royal Infirmary
Lindley
Huddersfield
HD3 3EA
United Kingdom
Huddersfield
HD3 3EA
United Kingdom
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Bradford
BD9 6RJ
United Kingdom
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Derby
DE22 3NE
United Kingdom
Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom
Fulwood
Preston
PR2 9HT
United Kingdom
Calderdale Royal Hospital
Salterhebble
Halifax
HX3 0PW
United Kingdom
Halifax
HX3 0PW
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Website | http://www.bham.ac.uk |
|---|---|
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
Health Technology Assessment Programme
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/06/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| 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/ |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2016 | Yes | No | |
| Results article | results | 01/07/2016 | Yes | No | |
| Results article | results | 01/04/2017 | Yes | No | |
| Plain English results | 24/03/2022 | No | Yes |
Editorial Notes
24/03/2022: Plain English results added.
18/08/2017: Internal edit.
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.
