ONE-SHOT Trial - Ultra-hypofractionated Single-dose SBRT for Prostate Cancer

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 at biopsy ≥ 4+3
• Androgen deprivation therapy or products known to affect PSA levels
• Impossibility to implant Calypso beacons
• History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from registration with the exception of curatively treated localized non-melanoma skin cancer
• Prior pelvic radiotherapy
• Previous surgery for prostate cancer
• Previous transurethral resection of the prostate (TURP) (< 12 weeks before registration)
• Hip prosthesis
• Severe or active co-morbidity likely to impact on the advisability of SBRT
• Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications