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Taking people in SwitzerlandPhase 1/2

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

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men with prostate cancer that has not spread outside the prostate. They would receive one single high dose of focused radiation (19 Gy).

Age
18 to 85 years
Sex
Men only
Disease stage
Prostate cancer (adenocarcinoma) confirmed by biopsy, clinical stage cT1c-2c with no spread to lymph nodes or other organs. Gleason score 3+3 or 3+4. PSA 15 ng/ml or lower. Prostate volume 70 cc or less on MRI.
Earlier treatment
No androgen deprivation therapy, no prior pelvic radiotherapy, no previous surgery for prostate cancer. No TURP within 12 weeks before registration.
Biomarker or test result
PSA 15 ng/ml or lower.

Main reasons for not taking part

  • Tumor stage cT3a-3b or T4, or spread to lymph nodes or elsewhere
  • Gleason score 4+3 or higher
  • Calypso beacons cannot be implanted
  • Hip prosthesis
  • Another cancer in the past, unless in remission for at least 3 years (except treated localized non-melanoma skin cancer)

Read by machine on 12 November 2026.

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, SwitzerlandContact: Thomas Zilli, MDTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

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.

ClinicalTrials.gov NCT03294889