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| Sponsor: | Scandinavian Prostate Cancer Group |
|---|---|
| Collaborator: |
Sanofi-Aventis |
| Information provided by: | Scandinavian Prostate Cancer Group |
| ClinicalTrials.gov Identifier: | NCT00653848 |
Purpose
As docetaxel is proven to be effective in late stages of prostate cancer with a large tumour burden it should be effective in primarily treated intermediate and high risk prostate cancer as an adjuvant treatment after radiotherapy to prevent early relapse. This will therefore be tested in a randomised phase III trial where patients will be randomized either to docetaxel or surveillance
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: docetaxel |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized Adjuvant Phase III Trial of Six Cycles of Docetaxel+Hormonal Treatment Versus Hormonal Treatment in Patients With Intermediate or High-Risk Prostate Cancer Treated With Radical Radiotherapy |
| Estimated Enrollment: | 924 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Docetaxel arm: Experimental
six of docetaxel every third week + hormonal treatment
|
Drug: docetaxel
docetaxel 75 mg/square meter i.v. every third week, six cycles
|
|
Control: No Intervention
hormonal treatment only
|
Primary endpoint:
Secondary endpoints:
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
One of the following:
Exclusion Criteria:
Contacts and Locations| Contact: Pirkko-Liisa I Kellokumpu-Lehtinen, Prof | +358505951103 | Pirkko-liisa.Kellokumpu-Lehtinen@uta.fi |
| Contact: Claes Ginman, MD | +4654655000 | Claes.Ginman@liv.se |
| Norway | |
| Jon R Iversen | Recruiting |
| Oslo, Norway | |
| Contact: Jon R Iversen | |
| Principal Investigator: | Pirkko-Liisa i Kellokumpu-Lehtinen, Prof | Tampere University Hospital |
More Information
| Responsible Party: | Tampere University Hospital ( Pirkko-Liisa Kellokumpu-Lehtinen, professor ) |
| Study ID Numbers: | SPCG-13, EudraCT 2006-001657-94 |
| Study First Received: | April 2, 2008 |
| Last Updated: | July 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00653848 History of Changes |
| Health Authority: | Finland: Finnish Medicines Agency |
|
Adjuvant treatment, intermediate and high risk, radical radiotherapy |
|
Docetaxel Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male Antineoplastic Agents |
Therapeutic Uses Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Pharmacologic Actions |