Stereotactic Body Radiation Therapy in Treating Patients with Localized High-Risk Prostate Cancer
- 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
- 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
I. To establish the efficacy of stereotactic body radiation therapy (SBRT) in patients with high-risk localized prostate cancer compared to historical data from clinical trials.
II. To establish the safety with physician-reported outcomes after SBRT in patients with high risk localized prostate cancer.
III. To establish the quality of life with patient-reported validated questionnaires after SBRT in patients with high risk localized prostate cancer.
Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician.
After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 5 years, and then every 12 months thereafter.
Trial Phase Phase NA
Trial Type Observational
UCLA / Jonsson Comprehensive Cancer Center
Christopher R. King
- Primary ID 13-001427
- Secondary IDs NCI-2014-02183, JCCCID410
- Clinicaltrials.gov ID NCT02296229