Phase II Study of Single-Dose Image-Guided Radiotherapy (SDRT) for Prostate Cancer

NARecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

June 1, 2019

Primary Completion Date

June 30, 2021

Study Completion Date

June 30, 2026

Conditions
Prostate Cancer
Interventions
RADIATION

IGRT 24 Gy Single dose

Previously untreated patients with prostate cancer will be treated with 24Gy in in one session.

PROCEDURE

Image-guided, volumetric intensity-modulated arc radiotherapy (IGRT-VMAT)

Patients enrolled in the study will undergo IGRT-VMAT with state-of-the-art treatment-planning and quality assurance procedures with emphasis on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility.

DEVICE

Rectal balloon with air filling

A rectal balloon with air filling will be used for prostate target immobilization and anatomical reproducibility.

DEVICE

Urethral catheter loaded with beacon transponders

A urethral catheter loaded with beacon transponders will be used to ensure set-up reproducibility and online target tracking.

Trial Locations (1)

1400-038

RECRUITING

Champalimaud Foundation, Lisbon

All Listed Sponsors
lead

Fundacao Champalimaud

OTHER