NCT03294889RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 14 May 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 22 Sept 2017
- Start date
- 1 Sept 2017
- Primary completion date
- 1 Oct 2022
- Lead sponsor
- University Hospital, Geneva
- Diseases
- Prostate cancer
- NCT number
- NCT03294889
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 45
- From 1 Sept 2017 to the primary completion date, 1 Oct 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Geneva Coordinator of this site? Confirm its status | Geneva | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.