Actively Recruiting
ONE-SHOT Trial - Ultra-hypofractionated Single-dose SBRT for Prostate Cancer
Led by University Hospital, Geneva · Updated on 2020-05-14
45
Participants Needed
1
Research Sites
682 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Geneva
Lead Sponsor
H
Humanitas Hospital, Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ONE-SHOT Trial - Ultra-hypofractionated Single-dose SBRT for Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital of Geneva
Geneva, Switzerland, 1205
Actively Recruiting
Research Team
T
Thomas Zilli, MD
CONTACT
L
Laurence Zulianello, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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