ONE-SHOT Trial – Ultra-hypofractionated Single-dose SBRT for Prostate Cancer
ONE-SHOT - Single Shot Radiotherapy for Localized Prostate Cancer. A Multicenter, Single Arm, Phase I/II Trial
About This Trial
- This study is testing whether delivering prostate radiation therapy in a single, highly focused session is safe and effective.
- It is designed for men with early-stage prostate cancer that has not spread outside the prostate gland.
- Before joining, patients will need to have tiny tracking markers placed inside the prostate to help guide the radiation accurately.
- To qualify, you must not have had previous pelvic radiation, artificial hips, or certain prostate surgeries, and you must agree to avoid fathering a child during and shortly after the study.
More Information
- 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.
Who Can Enroll
- Age Range: 18 - 85 years
- Gender: Male
- Who This Trial is For: This study is testing whether delivering prostate radiation therapy in a single, highly focused session is safe and effective.
Study Details
- Start Date: September 1, 2017
- Lead Sponsor: University Hospital, Geneva
Full 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 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
Treatments
- Radiation: Stereotactic body radition (SBRT)