ONE-SHOT Trial - Ultra-hypofractionated Single-dose SBRT for Prostate Cancer
Trial Parameters
Brief Summary
The main objective of the phase I/II trial is to determine the safety and efficacy of a single fraction SBRT at a dose of 19 Gy in patients with localized prostate cancer.
Eligibility Criteria
Inclusion Criteria: * Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures * Histologically confirmed adenocarcinoma of the prostate without small cell features * Tumor clinical stage cT1c-2c, pN0 or cN0, M0, according to UICC TNM 2009 * MRI staging must confirm American Joint Committee on Cancer (AJCC) stage T1, T2a, T2b or T2c * Gleason score at biopsy 3+3 or 3+4 (WHO 2016 Grade Groups 1, 2) * PSA ≤15 ng/ml * WHO performance status 0-1 * International Prostate Symptom Score ≤ 10 (alpha blockers allowed) * MRI-based volume estimation of prostate gland ≤ 70 cc * Patient agrees not to father a child during trial treatment and during 6 months thereafter Exclusion Criteria: * Tumor clinical stage cT3a-3b or T4 * Evidence of T3a, T3b or T4 disease as assessed by MRI * Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies. * Significant tumor on the transitional zone as assessed by MRI * Gleason