NCT02761889

Hypofractionated Image-Guided Radiotherapy (IGRT) With Organ Motion Mitigation and Urethral Sparing for Prostate Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Fundacao Champalimaud · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The present study evaluates the clinical outcomes following definitive ultra-high dose per fraction external beam radiation therapy delivered in patients with organ-confined adenocarcinoma of the prostate. Patients enrolled in the study will undergo image-guided, volumetric intensity-modulated arc radiotherapy (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. A rectal balloon with air filling will be used for prostate target immobilization and anatomical reproducibility, while a urethral catheter loaded with beacon transponders will be used to ensure set-up reproducibility and online target tracking. Previously untreated patients with prostate cancer will be treated with 45 Gy in five fractions of 9 Gy over 5 consecutive days. Patients will be followed at one month post-treatment and every 3 months for up to 12 months (+/- 4 weeks) and every 6 months (+/- 6 weeks) thereafter. Acute and late toxicity evaluations will focus, though not exclusively, on urinary, rectal and sexual functions and will be assessed through validated Expanded Prostate Cancer Index Composite (EPIC), International prostate symptom score (IPSS) and International index of erectile function (IIEF) questionnaires. Serum Prostate Specific Antigen (PSA) values will be drawn on the same schedule as clinical follow-up. Patients will be continuously monitored for a minimum of 5 years.

Conditions

• Adenocarcinoma of the Prostate

Interventions

Type	Name	Description
RADIATION	IGRT 45 Gy in 5 fractions of 9 Gy	Previously untreated patients with prostate cancer will be treated with 45 Gy in five fractions of 9 Gy over 5 consecutive days.
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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2017-09-30
• Completion: 2022-09-30
• First posted: 2016-05-04
• Last updated: 2019-07-23

Locations

1 site across 1 country: Portugal