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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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | 378 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Docetaxel arm
six of docetaxel every third week + hormonal treatment
|
Drug: docetaxel
docetaxel 75 mg/square meter i.v. every third week, six cycles
Other Name: LHRH ananlog 9 months
|
|
No Intervention: Control
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: | Pirkko-Liisa Kellokumpu-Lehtinen, professor, Tampere University Hospital |
| ClinicalTrials.gov Identifier: | NCT00653848 History of Changes |
| Other Study ID Numbers: | SPCG-13, EudraCT 2006-001657-94 |
| Study First Received: | April 2, 2008 |
| Last Updated: | June 15, 2010 |
| Health Authority: | Finland: Finnish Medicines Agency |
|
Adjuvant treatment, intermediate and high risk, radical radiotherapy |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |