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

Study Description

Brief 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.

Detailed Description:

Keywords

Eligibility

Minimum Age: 40 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Contact Details

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