Spots Global Cancer Trial Database for Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
Official Title: A Phase I and II Study of Stereotactic Body Radiation Therapy (SBRT) for Low and Intermediate Risk Prostate Cancer (SBRT Prostate)
Study ID: NCT00547339
Conditions
Study Description
Brief Summary: 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.
Detailed Description: OBJECTIVES: Primary * 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) Secondary * 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
University of Colorado Cancer Center at UC Health Sciences Center, Aurora, Colorado, United States
MD Anderson Cancer Center Orlando Florida, Orlando, Florida, United States
University of Minnesota Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States
Prairie Lakes Cancer Center, Watertown, South Dakota, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
Contact Details
Name: Robert D. Timmerman, MD
Affiliation: Simmons Cancer Center
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
