MRI-guided Brachytherapy and Salvage SBRT Program

University of Navarra

Status: Not yet enrolling

Conditions: Prostate Cancer (Post Prostatectomy)

Treatments: Radiation: Brachytherapy and MR-Guided SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT07132671

2024.224

Details and patient eligibility

About

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

Full description

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

Enrollment: 29 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patients with increasing PSA after RP and clinical evidence of PET PSMA/Choline+ and RMN+ isolated prostatic bed relapse (IPBR) that is implantable via transperineal route . The IPBR should be visible on TRUS imaging to allow proper implant placement.

1. Pathological confirmation is advised in all cases but it is not mandatory .

2. Patients with any of the following were not considered eligible:

   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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

MRI-guided Brachytherapy and Salvage SBRT Program

Experimental group

Description:

Brachytherapy and MR-guided SBRT

Treatment:

Radiation: Brachytherapy and MR-Guided SBRT