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Sponsors and Collaborators: |
NCIC Clinical Trials Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00651326 |
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.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: bicalutamide Drug: buserelin Drug: docetaxel Drug: flutamide Drug: goserelin Drug: leuprolide acetate Procedure: neoadjuvant therapy Procedure: quality-of-life assessment Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
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) |
Estimated Enrollment: | 530 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | April 2018 (Final data collection date for primary outcome measure) |
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.
Beginning at least 4 weeks after completion of chemotherapy, patients undergo pelvic radiotherapy once daily 5 days a week for up to 8 weeks.
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.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Considered to be at high risk for recurrence based on the presence of at least one of the following adverse prognostic features:
Negative pelvic and para-aortic lymph nodes on CT scan or MRI of the abdomen and pelvis
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Canada, Alberta | |
Tom Baker Cancer Centre - Calgary | Recruiting |
Calgary, Alberta, Canada, T2N 4N2 | |
Contact: David P. Skarsgard 403-521-3164 | |
Canada, British Columbia | |
British Columbia Cancer Agency - Centre for the Southern Interior | Recruiting |
Kelowna, British Columbia, Canada, V1Y 5L3 | |
Contact: Susan Ellard 250-712-3922 | |
British Columbia Cancer Agency - Vancouver Cancer Centre | Recruiting |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Contact: Michael McKenzie 604-877-6000 | |
Canada, Manitoba | |
CancerCare Manitoba | Recruiting |
Winnipeg, Manitoba, Canada, R3E 0V9 | |
Contact: Piotr Czaykowski 204-787-2783 | |
Canada, Ontario | |
Margaret and Charles Juravinski Cancer Centre | Recruiting |
Hamilton, Ontario, Canada, L8V 5C2 | |
Contact: Sebastien Hotte 905-387-9495 | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Andrew J. Bayley 416-946-2919 | |
R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa | Recruiting |
Oshawa, Ontario, Canada, L1G 2B9 | |
Contact: Wayne Koll 905-576-8711 | |
Canada, Quebec | |
McGill Cancer Centre at McGill University | Recruiting |
Montreal, Quebec, Canada, H2W 1S6 | |
Contact: M. Tamim Niazi 514-340-8288 |
Study Chair: | Michael R. McKenzie, MD, FRCPC | British Columbia Cancer Agency |
Investigator: | Kim N. Chi, MD | British Columbia Cancer Agency |
Study ID Numbers: | CDR0000589247, CAN-NCIC-PR12 |
Study First Received: | April 1, 2008 |
Last Updated: | July 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00651326 History of Changes |
Health Authority: | Unspecified |
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer |
Buserelin Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Goserelin Urogenital Neoplasms Genital Diseases, Male |
Flutamide Hormones Docetaxel Androgen Antagonists Leuprolide Bicalutamide Adenocarcinoma Prostatic Neoplasms Androgens |
Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Reproductive Control Agents Genital Diseases, Male Hormones Pharmacologic Actions |
Docetaxel Androgen Antagonists Neoplasms Neoplasms by Site Leuprolide Fertility Agents, Female Therapeutic Uses Fertility Agents Bicalutamide Prostatic Neoplasms Androgens |