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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00278356 |
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Imaging procedures, such as MRI, may help the doctor send x-rays directly to the tumor and nearby lymph nodes and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of MRI-guided radiation therapy in treating patients with prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Procedure: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Pilot Study of Image Guided Prostate and Pelvic Nodal Irradiation With Intensity Modulated Radiation Therapy (IMRT) in Prostate Cancer |
Estimated Enrollment: | 28 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a pilot, dose-escalation study.
After pathology is available and 2 months of neoadjuvant hormone therapy is complete, patients undergo MRI-guided intensity-modulated radiotherapy (IMRT) to the at-risk or positive lymph nodes 5 days a week for 8.5 weeks.
Cohorts of 3-6 patients receive escalating doses of IMRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 89 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Risk of lymph node metastasis ≥ 10% OR biopsy-proven positive lymph nodes
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Must receive neoadjuvant, concurrent, and adjuvant hormone therapy
Must receive a gonadotropin releasing-hormone agonist for concurrent and adjuvant therapy
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Principal Investigator: | Aradhana Kaushal, MD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000455048, NCI-05-C-0241, NCI-P6590 |
Study First Received: | January 16, 2006 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00278356 |
Health Authority: | Unspecified |
adenocarcinoma of the prostate stage II prostate cancer stage III prostate cancer stage IV prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Neoplasms Neoplasms by Site |