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

NCT03294889 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-05-14

No results posted yet for this 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.

Conditions

Interventions

RADIATION

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)

Sponsors & Collaborators

  • Humanitas Hospital, Italy

    collaborator OTHER

  • University of Zurich

    collaborator OTHER

  • Kantonsspital Graubünden

    collaborator OTHER

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Thomas Zilli, MD · University Hospital, Geneva

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2022-10-01
Completion
2030-10-01

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03294889 on ClinicalTrials.gov