Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT07900555
PHASE2

Hypofractionated Radiotherapy With Magnetic Resonance Imaging-Guided Focal Boost and Pelvic Irradiation in High-Risk Prostate Cancer

Sponsor: Haukeland University Hospital

View on ClinicalTrials.gov

Summary

This study evaluated long-term disease control and side effects of a moderately hypofractionated radiotherapy protocol for men with high-risk prostate cancer. The protocol combined three strategies in one course of 25 treatments: a higher dose (focal boost) to the tumor seen on magnetic resonance imaging (MRI), a reduced dose to the uninvolved parts of the prostate, and elective irradiation of the pelvic lymph nodes, together with hormone therapy. Patients were included at Haukeland University Hospital, Bergen, Norway, from 2014 to 2017, with outcomes evaluated up to 10 years after treatment.

Official title: Dose-Escalated Image-Guided Radiotherapy (IGRT) With Magnetic Resonance Imaging (MRI)-Based Target Definition for Locally and Regionally Advanced Prostate Cancer: A Phase II Study

Key Details

Gender

MALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

191

Start Date

2014-02-24

Completion Date

2025-10-01

Last Updated

2026-10-30

Healthy Volunteers

No

Interventions

RADIATION

Hypofractionated IMRT with focal simultaneous integrated boost and elective pelvic irradiation

Image-guided IMRT in 25 fractions: 2.9 Gy/fraction (72.5 Gy) to the MRI-defined tumour, 2.4 Gy/fraction (60 Gy) to the uninvolved prostate and seminal vesicles, and 2.0 Gy/fraction (50 Gy) to the elective pelvic lymph nodes, with a boost of 2.4 Gy/fraction (60 Gy) to involved lymph nodes in node-positive patients.

DRUG

Androgen Deprivation Therapy (ADT)

Androgen deprivation therapy started approximately 3 months before radiotherapy: an luteinizing hormone-releasing hormone (LHRH) analogue with at least 4 weeks of antiandrogen, or alternatively an LHRH antagonist. Planned duration 18 months if clinically tolerated. Antiandrogen monotherapy was an option in case of poor tolerance of the LHRH analogue.

Locations (1)

Haukeland University Hospital

Bergen, Vestland, Norway