Status:
RECRUITING
ONE-SHOT Trial - Ultra-hypofractionated Single-dose SBRT for Prostate Cancer
Lead Sponsor:
University Hospital, Geneva
Collaborating Sponsors:
Humanitas Hospital, Italy
University of Zurich
Conditions:
Prostate Cancer
Eligibility:
MALE
18-85 years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
Total dose and dose per fraction play an important role in the curative treatment of prostate cancer with radiotherapy (RT). Modern image guided external RT allows safe dose escalation of prostate can...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03294889
Start Date
September 1 2017
End Date
October 1 2030
Last Update
May 14 2020
Active Locations (1)
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1
University Hospital of Geneva
Geneva, Switzerland, 1205