MRI-guided Ultrahypofractionated SBRT Prostate Program

University of Navarra

Status: Not yet enrolling

Conditions: Prostate Cancer

Treatments: Radiation: MR-Guided SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT07132658

2024.198

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Optimal 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

Cautionary Inclusion Criteria

• 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

Exclusion Criteria

• Prior radiation therapy to the target areas
• Expected patient survival below 5 years
• Patient unable to undergo a MRI exam

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Initial Phase

Active Comparator group

Description:

Whole Gland 36.25Gy/5Rx

Treatment:

Radiation: MR-Guided SBRT

Study Phase

Experimental group

Description:

Whole Gland 27Gy/2Rx

Treatment:

Radiation: MR-Guided SBRT

Final Phase

Experimental group

Description:

Asymmetrical Whole Gland 27Gy/2Rx

Treatment:

Radiation: MR-Guided SBRT