High Dose Rate (HDR) Brachytherapy Salvage After Prostatectomy

NCT06982469 | Recruiting

• 1 other identifier: 2020.212
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the long-term effects of HDR Brachytherapy in men with isolated local relapses after radical prostatectomy. The main question it aims to answer is: Does HDR Brachytherapy increase control rates and decreases complications compared with conventional External Irradiation? Participants will be asked to receive HDR brachytherapy as part of their regular medical care for isolated local relapses after radical prostatectomy

Conditions

Prostate Cancer; Prostatectomy; Local Recurrence of Malignant Tumor of Prostate; Radiotherapy; Complications; Brachytherapy

Outcome Measures

Primary Outcomes (1)

• biochemical relapse-free survival (bRFS)

  Biochemical Relapse-Free Survival

  5-year

Study Arms (1)

Cohort 1

Patients with increasing prostatic specific antigen (PSA) after radical prostatectomy (RP) and clinical evidence of PET PSMA+ and MRI (magnetic resonance imaging)+ isolated prostatic bed relapse (IPBR) that is implantable via transperineal route . The IPBR should be visible on TRUS imaging to allow proper implant placement

Radiation: Brachytherapy

Interventions

Brachytherapy RADIATION

HDR brachytherapy

Cohort 1

Eligibility Criteria

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

Study Population

Patients with isolated tumor bed relapses after radical prostatectomy

You may qualify if:

• Patients with increasing PSA after RP and clinical evidence of PET PSMA/Choline+ and MRI+ 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 .
• Brachytherapy MRI-based dosimetry
• Patient written Informed Consent of the Institutional Review Board-approved protocol that discloses the investigational nature of the treatment as well as the available standard treatment options.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Clínica Universidad de Navarra

Pamplona, Foral Community of Navarre, 31008, Spain

RECRUITING

Related Publications (4)

• Carrie C, Magne N, Burban-Provost P, Sargos P, Latorzeff I, Lagrange JL, Supiot S, Belkacemi Y, Peiffert D, Allouache N, Dubray BM, Servagi-Vernat S, Suchaud JP, Crehange G, Guerif S, Brihoum M, Barbier N, Graff-Cailleaud P, Ruffion A, Dussart S, Ferlay C, Chabaud S. Short-term androgen deprivation therapy combined with radiotherapy as salvage treatment after radical prostatectomy for prostate cancer (GETUG-AFU 16): a 112-month follow-up of a phase 3, randomised trial. Lancet Oncol. 2019 Dec;20(12):1740-1749. doi: 10.1016/S1470-2045(19)30486-3. Epub 2019 Oct 16.

  PMID: 31629656 BACKGROUND

• Gonzalez-San Segundo C, Counago F, Gomez-Iturriaga A. Androgen Deprivation Therapy and Salvage Radiotherapy: Are We Missing Something? Eur Urol. 2019 Aug;76(2):260-261. doi: 10.1016/j.eururo.2019.01.045. Epub 2019 Feb 8. No abstract available.

  PMID: 30745145 BACKGROUND

• Carrie C, Hasbini A, de Laroche G, Richaud P, Guerif S, Latorzeff I, Supiot S, Bosset M, Lagrange JL, Beckendorf V, Lesaunier F, Dubray B, Wagner JP, N'Guyen TD, Suchaud JP, Crehange G, Barbier N, Habibian M, Ferlay C, Fourneret P, Ruffion A, Dussart S. Salvage radiotherapy with or without short-term hormone therapy for rising prostate-specific antigen concentration after radical prostatectomy (GETUG-AFU 16): a randomised, multicentre, open-label phase 3 trial. Lancet Oncol. 2016 Jun;17(6):747-756. doi: 10.1016/S1470-2045(16)00111-X. Epub 2016 May 6.

  PMID: 27160475 BACKGROUND

• Martinez-Monge R, Moreno M, Ciervide R, Cambeiro M, Perez-Gracia JL, Gil-Bazo I, Gaztanaga M, Arbea L, Pascual I, Aristu J. External-beam radiation therapy and high-dose rate brachytherapy combined with long-term androgen deprivation therapy in high and very high prostate cancer: preliminary data on clinical outcome. Int J Radiat Oncol Biol Phys. 2012 Mar 1;82(3):e469-76. doi: 10.1016/j.ijrobp.2011.08.002.

  PMID: 22284039 BACKGROUND

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.

  Clinica Universidad de Navarra Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Canel, Ph.D.

CONTACT

948255400; gcanel@unav.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: May 5, 2020
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2030
• Last Updated: June 19, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After Primary Completion
• Access Criteria: On request

Locations

ES (1)