MRI-guided Brachytherapy and Salvage SBRT Program

NCT ID: NCT07132671

Last Updated: 2025-08-20

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

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2030-06-30

Brief Summary

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Brachytherapy followed by MRI-guided irradiation has the potential to improve treatment results in patients with local relapses after radical prostatectomy

Detailed Description

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The goal of this clinical trial is to learn if the use of brachytherapy followed by MRI-guided irradiation increases the rates of tumor control and decreases the rates of adverse events in patients with tumor bed relapses after radical prostatectomy

Conditions

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Prostate Cancer (Post Prostatectomy)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MRI-guided Brachytherapy and Salvage SBRT Program

Brachytherapy and MR-guided SBRT

Group Type EXPERIMENTAL

Brachytherapy and MR-Guided SBRT

Intervention Type RADIATION

HDR Brachytherapy followed by MR-guided SBRT

Interventions

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Brachytherapy and MR-Guided SBRT

HDR Brachytherapy followed by MR-guided SBRT

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1. Distance \< 5mm from the edge of the IPBR to any of the defined OARs (UV anastomosis, rectal wall, bladder wall, external urinary sphincter)
2. Distant Metastases
3. Isolated nodal relapses
4. Prior Irradiation to the IPBR area
5. Multicentric IPBRs
6. Life expectancy of less than 5 years or inability to tolerate and comply with an HDR procedure
3. No prior radiation therapy to the target areas;
4. Karnofsky performance status \> 70 with medical condition not contraindicating treatment with radical intent including maximal TURBT and concomitant chemotherapy;
5. WBC equal or greater than 3500 mm3; platelet count equal or greater than 135000 mm3; hemoglobin equal or greater than 10 gr/L; BUN equal or less than 20; serum creatinine equal or less than 2.0.
6. Ability to undergo MRI scanning.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rafael Martínez-Monge, M.D.

Role: PRINCIPAL_INVESTIGATOR

Clínica Universidad de Navarra

Marta Gimeno-Morales, M.D.

Role: PRINCIPAL_INVESTIGATOR

Clínica Universidad de Navarra

Central Contacts

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Beatriz Ramos Aguirre, M.S.

Role: CONTACT

+34948255400 ext. 2772

Other Identifiers

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2024.224

Identifier Type: -

Identifier Source: org_study_id

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