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| [ Print-friendly version ] |
| A randomised phase III trial of docetaxel plus prednisolone vs docetaxel with prednisolone plus either zoledronic acid, strontium-89 or both agents combined (TRAPEZE) |
| ISRCTN | ISRCTN12808747 |
| ClinicalTrials.gov identifier | NCT00554918 |
| Public 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) |
| Scientific title | |
| Acronym | TRAPEZE |
| Serial number at source | HTA 06/303/205; PR2100 |
| Study hypothesis |
Please note that the following amendments have been made to this record as of 10/01/2008:
1. Public trial title has been updated 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 anticipated start and end dates have been updated from 01/01/2005 and 01/01/2009 to 01/04/2007 and 28/02/2013, respectively. Study aim: To compare the efficacy and safety of the four clinical trial arms in the treatment of hormone refractory prostate cancer (HRPC0 patients). As of 15/02/2011 the target number of participants has been updated from 300 to 1240. Protocol can be found at: http://www.trapeze.bham.ac.uk/documents/TrapezeProtocolV7.pdf |
| Lay summary | http://www.cancerhelp.org.uk/trials/a-trial-looking-at-docetaxel-zoledronic-acid-and-strontium-89-for-prostate-cancer-that-has-spread-to-the-bones |
| Ethics approval | South West Research Ethics Committee on 09/11/2004 (ref: 04/MRE06/48) |
| Study design | Phase III randomised controlled feasibility trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Prostate Cancer |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/04/2007 |
| Anticipated end date | 28/02/2013 |
| Status of trial | Ongoing |
| Patient information material | Patient information sheet can be found at http://www.trapeze.bham.ac.uk/documents/TRAPEZE_PatientInfo-v2.pdf |
| Target number of participants | Added 15/02/2011: 1240 split into 4 groups. (At time of registration: 300) |
| Interventions |
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 |
| Primary outcome measure(s) |
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 measure(s) |
1. Health care economic analysis
2. Changes in bone mineral density 3. Biological profiling for prognostic and predictive indicators |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | http://www.trapeze.bham.ac.uk |
| Publications | |
| Contact name | Prof Nicholas James |
| Address |
Department of Clinical Oncology
University of Birmingham Institute for Cancer Studies Vincent Drive Edgbaston |
| City/town | Birmingham |
| Zip/Postcode | B15 2TT |
| Country | United Kingdom |
| Tel | +44 (0)121 4144097 |
| N.D.James@bham.ac.uk | |
| Sponsor | University of Birmingham (UK) |
| Address |
University of Birmingham
Edgbaston |
| City/town | Birmingham |
| Zip/Postcode | B15 2TT |
| Country | United Kingdom |
| Sponsor website: | http://www.bham.ac.uk |
| Date applied | 24/08/2005 |
| Last edited | 02/08/2011 |
| Date ISRCTN assigned | 08/09/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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