Stereotactic body radition (SBRT): Ultra-hypofractionated single-fraction SBRT with urethra-sparing with image-guidance and intra-fractional control motion with the Calypso® system.
* 19 Gy in a single fraction to the whole prostate gland ± proximal seminal vesicles
* 17 Gy in a single fraction to the urethra planning-risk volume (PRV)
Study 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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Clinical performance — 3 months Toxicity will be evaluated using Grade ≥ 3 genitourinary and/or gastrointestinal acute adverse event (AE) during the first 3 month according to CTCAE classification v.4.03 (Phase I).
Progression free survival (PFS) — 3 years The primary endpoint is 3-years biochemical relapse free survival (bRFS). bRFS and its 97.5% one-sided confidence interval (CI) will be determined using the Kaplan Meier method. If the expected value of 96% isn't included in this interval, the efficacy of the experimental treatment will be questioned. (Phase II).
Trial sites (1)
Facility
City
Region
Status
University Hospital of Geneva
Geneva
Switzerland
Recruiting
More University Hospital, Geneva trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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