MRI-guided Brachytherapy and Salvage SBRT Program

NCT07132671 | Not Yet Recruiting

• 1 other identifier: 2024.224
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Prostate Cancer (Post Prostatectomy)

Keywords

Prostate Cancer; Prostate Bed Relapse; Brachytherapy; MR-Guided SBRT

Outcome Measures

Primary Outcomes (2)

• Biochemical control

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

  5-year

• Adverse Events

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

  5-year

Secondary Outcomes (1)

• QOL

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

Study Arms (1)

MRI-guided Brachytherapy and Salvage SBRT Program

EXPERIMENTAL

Brachytherapy and MR-guided SBRT

Radiation: Brachytherapy and MR-Guided SBRT

Interventions

Brachytherapy and MR-Guided SBRT RADIATION

HDR Brachytherapy followed by MR-guided SBRT

MRI-guided Brachytherapy and Salvage SBRT Program

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Rafael Martínez-Monge, M.D.

  Clínica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

• Marta Gimeno-Morales, M.D.

  Clínica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beatriz Ramos Aguirre, M.S.

CONTACT

+34948255400; ucicec@unav.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: August 20, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: July 1st, 2025 - June 30th, 2030
• Access Criteria: On request