Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
Recruitment status was: Recruiting
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.
Radiation: stereotactic body radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I and II Study of Stereotactic Body Radiation Therapy (SBRT) for Low and Intermediate Risk Prostate Cancer (SBRT Prostate)|
- Maximum tolerated dose (MTD) or a dose of 50 Gy total (whichever comes first) [ Designated as safety issue: Yes ]
- 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 [ Designated as safety issue: Yes ]
- 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 [ Designated as safety issue: Yes ]
- Non-GU and non-GI toxicity [ Designated as safety issue: Yes ]
- Biochemical failure defined as a rise in the PSA level by more than 2 ng/mL above the lowest level (nadir) achieved after treatment [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Disease-specific survival [ Designated as safety issue: No ]
- Clinical progression including local/regional and distant relapse [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Estimated Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547339
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas|
|Dallas, Texas, United States, 75390|
|Study Chair:||Robert D. Timmerman, MD||Simmons Cancer Center|