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
- Patient with any evidence of disease beyond the seminal vesicles, including in regional lymph nodes, on standard CT scan, MRI scan, or advanced imaging such as 11C-acetate positron emission tomography (PET)/CT, 68Ga-prostate specific membrane antigen (PSMA) PET/CT, 18Fflucivlovine PET/CT, or 18NaF PET/CT (i.e., no N+ or cM+ patients are eligible)
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.
IV. To collect germ-line deoxyribonucleic acid (DNA) and nucleic acids from cancer patients to further investigate
the association and identify new germ-line mutations that impact cancer predisposition. (Germ-line substudy primary objective)
V. To investigate the role of germ-line mutations in predicting cancer outcome and response to therapy. (Germ-line substudy primary objective)
I. To determine the effect of the identified variants on tumor micro ribonucleic acid (miRNA), protein and gene expression. (Germ-line substudy secondary objective)
II. To study expression of DNA, ribonucleic acid (RNA) or protein in the blood of cancer patients with and
without variants of interest to discover correlations between such levels and the presence of cancer and/or
response to therapy in these patients. (Germ-line substudy secondary objective)
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
- Primary ID 13-001427
- Secondary IDs NCI-2014-02183, JCCCID410
- Clinicaltrials.gov ID NCT02296229