A Phase I and II Study of Stereotactic Body Radiation Therapy (SBRT) for Low and Intermediate Risk Prostate Cancer (SBRT Prostate)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- University of Texas Southwestern Medical Center
- Enrollment
- 94
- Locations
- 5
- Primary Endpoint
- Number of Participants With Dose Limiting Toxicity (Phase 1 Only)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Robert Timmerman
Professor of Medicine
University of Texas Southwestern Medical Center
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants With Dose Limiting Toxicity (Phase 1 Only)
Time Frame: 90 days after start of treatment
Dose-limiting toxicity (DLT) was defined as grade 3 to 5 GI, genito urinary, sexual, or neurologic toxicity attributed to therapy occurring within 90 days of registration using Common Terminology Criteria of Adverse Events(version 3)
No. of Late Severe GU Toxicity (for Phase 2 Only)
Time Frame: 18 months
To determine late severe GU toxicity defined as grade 3-5 occurring between 279-540 days (i.e., 9-18 months) from the start of protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
No. of Late Severe GI Toxicity (for Phase 2 Only)
Time Frame: 18 months
To determine late severe GI toxicity defined as grade 3-5 occurring between 279-540 days (i.e., 9-18 months) from the start of protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
Secondary Outcomes
- GU Toxicity (Only Phase 2)(9 months from start of treatment)
- GI Toxicity(9 months from start of treatment)
- Non-GU Toxicity(60 months)
- Non-GI Toxicity(60 months)
- Freedom From Biochemical Failure(36 months)
- Overall Survival(60 months)
- Disease Specific Survival(60 months)
- Clinical Progression Including Local/Regional and Distant Relapse(60 months)