NCT03294889Recruiting
ONE-SHOT Trial - Ultra-hypofractionated Single-dose SBRT for Prostate Cancer
Summary
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 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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 1 · Phase 2
- Study type
- Interventional
- Countries
- Switzerland
- Sponsor
- University Hospital, Geneva(Other)
- Protocol no.
- 2017-01236
- Conditions
- Prostate Cancer
- Interventions
- Radiation
Treatments studied
- Stereotactic body radition (SBRT)
Collaborators
Humanitas Hospital, Italy, University of Zurich, Kantonsspital Graubünden
Locations · 1
- Geneva, SwitzerlandUniversity Hospital of GenevaRecruiting at this site
In total, worldwide, the only site listed in the registry is recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: May 14, 2020).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
Other identifiers
- 2017 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.