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| Descriptive Information Fields | |||||||||
| Brief Title † | Androgen Suppression Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With High-Risk Localized Prostate Cancer | ||||||||
| Official Title † | A Phase III Study of Neoadjuvant Docetaxel and Androgen Suppression Plus Radiation Therapy Versus Androgen Suppression Alone Plus Radiation Therapy for High-Risk Localized Adenocarcinoma of the Prostate (DART) | ||||||||
| Brief Summary | RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, leuprolide, buserelin, and goserelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving androgen suppression therapy together with radiation therapy is more effective with or without docetaxel in treating prostate cancer. PURPOSE: This randomized phase III trial is studying androgen suppression therapy, radiation therapy, and docetaxel to see how well they work compared with androgen suppression therapy and radiation therapy in treating patients with high-risk localized prostate cancer. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≤ 7 vs ≥ 8), baseline prostate-specific antigen (PSA) (> 20 ng/mL vs ≤ 20 ng/mL), and participating center. Patients are randomized to 1 of 2 treatment arms.
Patients complete quality of life questionnaires at baseline, periodically during treatment, and then every 6 months for 5 years. After completion of study treatment, patients are followed at 3 and 6 months, every 6 months for 5 years, and then annually thereafter. |
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| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized | ||||||||
| Primary Outcome Measure † | Disease-free survival [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Overall survival [ Designated as safety issue: No ] Time to biochemical disease progression [ Designated as safety issue: No ] Time to local disease progression [ Designated as safety issue: No ] Time to distant disease progression [ Designated as safety issue: No ] Time to next anti-cancer therapy [ Designated as safety issue: No ] Progression-free survival [ Designated as safety issue: No ] Degree of prostate-specific antigen (PSA) suppression prior to radiotherapy [ Designated as safety issue: No ] Quality of life [ Designated as safety issue: No ] Adverse events [ Designated as safety issue: Yes ] |
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| Condition † | Prostate Cancer | ||||||||
| Intervention † | Drug: bicalutamide Drug: buserelin Drug: docetaxel Drug: flutamide Drug: goserelin Drug: leuprolide acetate Procedure: neoadjuvant therapy Procedure: quality-of-life assessment Procedure: radiation therapy |
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| MEDLINE PMIDs | |||||||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 530 | ||||||||
| Start Date † | March 2008 | ||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Male | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | Canada | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00651326 | ||||||||
| Organization ID | CDR0000589247 | ||||||||
| Secondary IDs †† | CAN-NCIC-PR12 | ||||||||
| Study Sponsor † | National Cancer Institute of Canada | ||||||||
| Collaborators †† | National Cancer Institute (NCI) | ||||||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | May 2008 | ||||||||
| First Received Date † | April 1, 2008 | ||||||||
| Last Updated Date | July 23, 2008 | ||||||||