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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00450411 |
RATIONALE: Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well ultrasound-guided implant radiation therapy works in treating patients with locally recurrent prostate cancer previously treated with external-beam radiation therapy.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Radiation: brachytherapy Radiation: iodine I 125 Radiation: palladium Pd 103 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Prospective Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy |
Estimated Enrollment: | 96 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a prospective, multicenter study.
Patients undergo transperineal ultrasound-guided iodine I 125 or palladium Pd 103 brachytherapy.
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate meeting the following criteria:
Stage I-II disease (T1-T2c) at initial diagnosis (prior to external-beam radiotherapy), meeting one of the following criteria:
Locally recurrent disease > 30 months after completion of prior external-beam radiotherapy
No histologic or radiologic evidence of tumor involvement of regional lymph nodes (N1)
PATIENT CHARACTERISTICS:
No prior invasive (except nonmelanoma skin cancer) or hematological (e.g., acute leukemia, aggressive lymphoma, myeloma) malignancy unless disease-free for ≥ 3 years
No severe, active comorbidity, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, California | |
California Cancer Center - Woodward Park Office | Recruiting |
Fresno, California, United States, 93720 | |
Contact: Brent L. Kane 559-447-4050 | |
United States, Indiana | |
Methodist Cancer Center at Methodist Hospital | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Contact Person 317-962-8288 | |
United States, New Jersey | |
University Medical Center at Princeton | Recruiting |
Princeton, New Jersey, United States, 08540-3298 | |
Contact: Douglas A. Fein 609-497-4000 | |
United States, Ohio | |
Summa Center for Cancer Care at Akron City Hospital | Recruiting |
Akron, Ohio, United States, 44309-2090 | |
Contact: Clinical Trials Office - Akron City Hospital 330-375-6101 | |
United States, Oklahoma | |
Oklahoma University Cancer Institute | Recruiting |
Oklahoma City, Oklahoma, United States, 73104 | |
Contact: Terence S. Herman 405-271-6822 | |
United States, Pennsylvania | |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19107-5541 | |
Contact: Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer 215-955-6084 | |
United States, Wisconsin | |
Gundersen Lutheran Center for Cancer and Blood | Recruiting |
La Crosse, Wisconsin, United States, 54601 | |
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center 608-775-2385 cancerctr@gundluth.org | |
Canada, British Columbia | |
BCCA - Fraser Valley Cancer Centre | Recruiting |
Surrey, British Columbia, Canada, V3V 1Z2 | |
Contact: Winkle B. Kwan 604-930-2098 | |
British Columbia Cancer Agency - Centre for the Southern Interior | Recruiting |
Kelowna, British Columbia, Canada, V1Y 5L3 | |
Contact: Ross M. Halperin 250-712-3900 | |
British Columbia Cancer Agency - Vancouver Cancer Centre | Recruiting |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Contact: Mira Keyes 604-877-6000 | |
British Columbia Cancer Agency - Vancouver Island Centre | Recruiting |
Victoria, British Columbia, Canada, V8R 6V5 | |
Contact: Abraham S. Alexander 250-519-5500 |
Study Chair: | Juanita M. Crook, MD | Princess Margaret Hospital, Canada |
Responsible Party: | Radiation Therapy Oncology Group ( Walter John Curran, Jr ) |
Study ID Numbers: | CDR0000533887, RTOG-0526 |
Study First Received: | March 20, 2007 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00450411 History of Changes |
Health Authority: | Unspecified |
adenocarcinoma of the prostate recurrent prostate cancer stage I prostate cancer stage II prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Iodine Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Recurrence |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |