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RECRUITING
NCT04831970

POst-Prostatectomy Ablative Radiation Therapy

Sponsor: University of Milano Bicocca

View on ClinicalTrials.gov

Summary

The use of hypofractionated radiotherapy for prostate cancer has matured to a point that in current guidelines extremely hypofractionated image-guided IMRT regimens (6 Gy per fraction or greater) can be considered an alternative to conventionally fractionated regimens at clinics with appropriate technology, physics and clinical expertise. The delivery of fewer and larger fractions with hypofractionation compared to conventional radiotherapy might effectively improve the therapeutic ratio while maintaining isoeffective tumour doses, thus, shortening overall treatment time. In the present study, patients will undergo postoperative image-guided SBRT by means of volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance procedures. Normal tissue sparing and delivery accuracy are accomplished by the use of devices that ensure stability and beam location reproducibility. The primary endpoint is to evaluate the cumulative incidence of treatment related toxicities and adverse events in the acute (\< 90 days from the end of treatment) and late (\> 90 days) setting.

Key Details

Gender

MALE

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2021-04-15

Completion Date

2026-12-31

Last Updated

2022-10-25

Healthy Volunteers

No

Locations (2)

Radiation Oncology, Humanitas Cancer Center (Humanitas University)

Rozzano, MI, Italy

Radiation Oncology, ASST Monza (University of Milan Bicocca)

Monza, Italy