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

Adenocarcinoma of the Prostate Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02761889
Study type Interventional
Source Fundacao Champalimaud
Contact
Status Active, not recruiting
Phase N/A
Start date May 1, 2013
Completion date September 30, 2022
View Details
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