Study of Stereotactic Body Radiotherapy (SBRT) for High-Risk Localized Prostrate Cancer

13-001427

This clinical trial studies stereotactic body radiation therapy in treating patients with high-risk prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Stereotactic body radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Studying quality of life in patients undergoing stereotactic body radiation therapy may help identify the long-term effects of treatment on patients with prostate cancer.

2014-01-27

2025-01-27

2026-01-27

Active (not recruiting)

220

Inclusion Criteria: * Histologically confirmed primary non-metastatic adenocarcinoma of the prostate * Risk-group classification into the D’Amico or National Comprehensive Cancer Network (NCCN) ‘high-risk’ group, as defined by the presence of any one of the following high-risk factors: * Pre-biopsy prostate-specific antigen (PSA) \>= 20 * Biopsy Gleason score 8-10 * Clinical stage T3 * No pelvic nodal metastases (based on computed tomography \[CT\] or magnetic resonance imaging \[MRI\] findings) * No distant metastases, based upon: * CT scan or MRI of the pelvis within 120 days prior to registration * Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis * Karnofsky performance status (KPS) \>= 70 * Ability to understand, and willingness to sign, the written informed consent * Patient will have opted for SBRT among definitive treatment choices Exclusion Criteria: * Patients with any evidence of distant metastases * Hormonal therapy (luteinizing hormone-releasing hormone \[LHRH\] agonist or oral anti-androgen) exceeding 4 months prior to registration * Prior cryosurgery, high intensity focused ultrasound (HIFU) or brachytherapy of the prostate * Prior pelvic radiotherapy * History of Crohn’s disease or Ulcerative colitis

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 220, 'type': 'ESTIMATED'}}

2024-01-19