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Clinical Trials/NCT07132671
NCT07132671Not yet recruitingNot Applicable

MRI-guided Brachytherapy + Salvage SBRT Program for Patients With Prostate Bed Relapses After Radical Prostatectomy

Clinica Universidad de Navarra, Universidad de Navarra0 sites29 target enrollmentStarted: October 1, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
29
Primary Endpoint
Biochemical control
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Detailed 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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion 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.
  • •Pathological confirmation is advised in all cases but it is not mandatory .
  • •Patients with any of the following were not considered eligible:
  • •Distance < 5mm from the edge of the IPBR to any of the defined OARs (UV anastomosis, rectal wall, bladder wall, external urinary sphincter)
  • •Distant Metastases
  • •Isolated nodal relapses
  • •Prior Irradiation to the IPBR area
  • •Multicentric IPBRs
  • •Life expectancy of less than 5 years or inability to tolerate and comply with an HDR procedure
  • •No prior radiation therapy to the target areas;
  • •Karnofsky performance status > 70 with medical condition not contraindicating treatment with radical intent including maximal TURBT and concomitant chemotherapy;
  • •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.
  • •Ability to undergo MRI scanning.

Exclusion Criteria

  • Not provided

Arms & Interventions

MRI-guided Brachytherapy and Salvage SBRT Program

Experimental

Brachytherapy and MR-guided SBRT

Intervention: Brachytherapy and MR-Guided SBRT (Radiation)

Outcomes

Primary Outcomes

Biochemical control

Time Frame: 5-year

To achieve 5-year biochemical control rate in 85% of the patients.

Adverse Events

Time Frame: 5-year

To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.

Secondary Outcomes

  • QOL(From enrollment to extended follow-up at 5 years with QOL assessment at 3, 6, 12 months after treatment and yearly thereafter)

Investigators

Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Sponsor Class
Other
Responsible Party
Sponsor

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