Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00547339|
Recruitment Status : Unknown
Verified June 2010 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : October 22, 2007
Last Update Posted : February 21, 2011
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with prostate cancer.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: stereotactic body radiation therapy||Phase 1 Phase 2|
- To escalate the dose of stereotactic body radiotherapy (SBRT) to a tumoricidal dose without exceeding the maximum tolerated dose in patients with organ-confined prostate cancer. (Phase I)
- To determine the late, severe grade 3-5 genitourinary and gastrointestinal toxicity occurring between 270-540 days (i.e., 9-18 months) from the start of the protocol treatment as assessed by CTCAE v3.0. (Phase II)
- To determine the dose-limiting toxicity of SBRT in these patients. (Phase I)
- To determine the 2-year biochemical (PSA) control (freedom from PSA failure), disease-free and overall survival, local control, freedom from distant metastases, and the incidence of high-grade adverse events of any type in patients treated with this therapy in order to determine if the therapy is promising enough for further clinical investigation. (Phase II)
OUTLINE: This is a multicenter, phase I dose-escalation study followed by a phase II open-label study.
- Phase I: Patients undergo 5 treatments of stereotactic body radiotherapy (SBRT).
- Phase II: Patients undergo SBRT at the maximum tolerated dose as in phase I. After completion of study treatment, patients are followed at 1.5, 3, 6, 9, and 12 months, every 6 months for 5 years, and then once a year for years 5-10.
PROJECTED ACCRUAL: A total of 97 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||97 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase I and II Study of Stereotactic Body Radiation Therapy (SBRT) for Low and Intermediate Risk Prostate Cancer (SBRT Prostate)|
|Study Start Date :||July 2006|
|Estimated Primary Completion Date :||October 2010|
- Maximum tolerated dose (MTD) or a dose of 50 Gy total (whichever comes first)
- Late severe genitourinary (GU) and gastrointestinal (GI) toxicity defined as grade 3-5 toxicity occurring between 270-540 days (i.e., 9-18 months) from the start of the protocol treatment as assessed by CTCAE v3.0
- Acute severe GU and GI toxicity defined as grade 3-5 toxicity occurring prior to 270 days from the start of protocol treatment as assessed by CTCAE v3.0
- Non-GU and non-GI toxicity
- Biochemical failure defined as a rise in the PSA level by more than 2 ng/mL above the lowest level (nadir) achieved after treatment
- Overall survival
- Disease-specific survival
- Clinical progression including local/regional and distant relapse
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547339
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097|
|Study Chair:||Robert D. Timmerman, MD||Simmons Cancer Center|