Tests one high-dose radiation treatment for localized prostate cancer
Tests a single high-dose radiation session in adults with localized prostate cancer.
Plain-language title generated from the registry record
Registry title: ONE-SHOT Trial - Ultra-hypofractionated Single-dose SBRT for Prostate Cancer
Key facts
- Where
- Geneva, SwitzerlandSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT03294889, who can take part
Where in Switzerland
- University Hospital of GenevaGeneva, SwitzerlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Geneva
- Trial code
- NCT03294889
- Record updated
- 14 May 2020
- Original description
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.Read full original descriptionShow less
ONE-SHOT - Single Shot Radiotherapy for Localized Prostate Cancer. A Multicenter, Single Arm, Phase I/II Trial
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.
Inclusion: 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: Androgen deprivation therapy or products known to affect PSA levels; Impossibility to implant Calypso beacons; Prior pelvic radiotherapy; Previous surgery for prostate cancer; Previous transurethral resection of the prostate (TURP) (< 12 weeks before registration); Evidence of T3a, T3b or T4 disease as assessed by MRI; Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies; 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; 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; Tumor clinical stage cT3a-3b or T4; Significant tumor on the transitional zone as assessed by MRI; Gleason at biopsy ≥ 4+3; Hip prosthesis; Severe or active co-morbidity likely to impact on the advisability of SBRT.