Clinical Trials in Switzerland / NCT03294889
Recruiting Phase 1/2

ONE-SHOT Trial - Ultra-hypofractionated Single-dose SBRT for Prostate Cancer

NCT03294889 · tracked via the Priya Life Science Switzerland tracker
Phase
Phase 1/2
Started
2017-09-01
Last updated
2020-05-14

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Stereotactic body radition (SBRT)

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)

Trial sites (1)

FacilityCityRegionStatus
University Hospital of Geneva Geneva Switzerland Recruiting

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Official registry record

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.

View NCT03294889 on ClinicalTrials.gov ↗ ← All trials in Switzerland