MRI-guided Ultrahypofractionated SBRT Prostate Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2030-06-30

Brief Summary

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The goal of this clinical trial is to learn if the use of MRI-guided asymmetric ultrahipofractionated irradiation (2 fractions with dose increase in the tumor areas and dose sparing in urethra, rectum and neurovascular bundles) produces similar results in terms of local control and complications to standard 5-fraction SBRT.

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Detailed Description

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The implementation of Magnetic Resonance Image Guided Radiotherapy (MRgRT) into a Prostate Cancer Program aims to reproduce the results obtained with state-of-the-art brachytherapy or EBRT with the added advantage of convenience and lack of invasiveness.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Initial Phase

Whole Gland 36.25Gy/5Rx

Group Type ACTIVE_COMPARATOR

MR-Guided SBRT

Intervention Type RADIATION

MR-Guided SBRT

Study Phase

Whole Gland 27Gy/2Rx

Group Type EXPERIMENTAL

MR-Guided SBRT

Intervention Type RADIATION

MR-Guided SBRT

Final Phase

Asymmetrical Whole Gland 27Gy/2Rx

Group Type EXPERIMENTAL

MR-Guided SBRT

Intervention Type RADIATION

MR-Guided SBRT

Interventions

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MR-Guided SBRT

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Patients with low to favorable intermediate-risk prostate cancer as per the NCCN stratification criteria .
* No prior radiation therapy to the target areas
* Expected patient survival \>5 years
* Patient able to undergo a MRI exam

* Suboptimal candidates for high-dose therapy such as elderly, frail patients or patients with large volume glands (i.e, \>60cm3) or extensive TURP in the prior 6-12 months should be considered cautionary indications.
* Patients with higher risk but low volume disease not candidates for ENI may be treated on an individual basis