A Phase I and II Study of Stereotactic Body Radiation Therapy (SBRT) for Low and Intermediate Risk Prostate Cancer (SBRT Prostate)
- 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
- 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.
Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) or a dose of 50 Gy total (whichever comes first)
Robert D. Timmerman, MD
Simmons Cancer Center
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|