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Sponsors and Collaborators: |
Schiffler Cancer Center Kent E. Wallner, M.D. Sylvester, John, M.D. |
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Information provided by: | Schiffler Cancer Center |
ClinicalTrials.gov Identifier: | NCT00243646 |
Determine the role of androgen deprivation therapy in high risk patients receiving 45 Gy of pelvic radiotherapy plus a Pd-103 boost and the impact of the duration of ADT in hormonally-manipulated patients.
Condition | Intervention | Phase |
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Prostate Cancer |
Procedure: External beam radiation Drug: Lupron Drug: Casodex |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial |
Estimated Enrollment: | 350 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | August 2009 |
In calender year 2005, 220, 000 men will be diagnosed with prostate cancer and approximately 30,000 will subsequently die of metastatic disease. Although the vast majority of men will be diagnosed with clinically localized and potentially curable disease, the selection of one local modality over another remains a focus of significant controversy within the uro-oncology community. However, patients with higher risk features are most often managed with radiotherapeutic approaches to include androgen deprivation therapy.
Prostate brachytherapy represents the ultimate-three dimensional conformal therapy and permits dose escalation far exceeding other modalities. Following permanent prostate brachytherapy with or without supplemental external beam radiation therapy, favorable long-term biochemical outcomes have been reported for patients with low, intermediate and high risk features with a morbidity profile that compares favorably with competing local modalities (1,2).
Several prospective randomized trials have demonstrated that androgen deprivation therapy in conjunction with conventional doses of external beam radiation therapy (65-70 Gy)results in improvement in disease-free and overall survival in patients with locally advanced prostate cancer (3,4).
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gregory S. Merrick, MD | 304-243-3490 | gmerrick@urologicresearchinstitute.org |
Contact: Kent E Wallner, MD | 206-768-5356 | Kent.Wallner@med.va.gov |
United States, Washington | |
Groupe Health Cooperative, Veterans Adminstration Hospital and University of Washington | Recruiting |
Seattle, Washington, United States, 98108 | |
Contact: Kent E. Wallner, MD 206-768-5356 kent.wallner@med.va.gov | |
Seattle Prostate Institute | Recruiting |
Seattle, Washington, United States, 98104 | |
Contact: John Sylvester, MD 206-215-2480 johnsylvester@seattleprostate.com | |
United States, West Virginia | |
Schiffler Cancer Center | Recruiting |
Wheeling, West Virginia, United States, 26003 | |
Contact: Gregory S. Merrick, MD 304-243-3490 gmerrick@urologicresearchinstitute.org | |
Contact: Robin Stipetich, RN, OCN 304-243-3490 | |
Principal Investigator: Gregory S. Merrick, MD |
Principal Investigator: | Gregory S Merrick, MD | Schiffler Cancer Center, Wheeling, WV |
Study Chair: | Kent E. Wallner, MD | Group Health Cooperative, Veterans Administration Hospital, and University of Washington |
Study Chair: | John Sylvester, MD | Seattle Prostate Institute Seattle, WA 98104 |
Study ID Numbers: | 05-8-4 |
Study First Received: | October 20, 2005 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00243646 |
Health Authority: | United States: Institutional Review Board |
Radiation therapy Brachytherapy Prostatic neoplasm |
Prostatic Diseases Genital Neoplasms, Male Leuprolide Bicalutamide |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |