High Dose Rate (HDR) Brachytherapy Salvage After Prostatectomy

NCT ID: NCT06982469

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-05
• Study Completion Date: 2030-05-01

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

Detailed Description

HDR brachytherapy appears to be an ideal technique for dose escalation in PET/MRI+ (positron emission tomography) , small, well-defined IPBR that can be accessed and visualized through the perineal route with transrectal ultrasound (TRUS) guidance. Additionally, HDR brachytherapy can spare from high dose irradiation most of the vesicourethral anastomosis, the external urinary sphincter (EUS) and the penile bulb. This may be crucial in circular structures such as EUS that are particularly sensitive to whole-volume irradiation but tolerate well high small-volume doses provided that the rest of the EUS is spared.

In this study, HDR brachytherapy will be combined with external beam radiation and 6 months of androgen deprivation therapy to decrease the prostate bed volume irradiated at high-doses while increasing the radiation dose in the PET/MRI+ areas.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Brachytherapy

Intervention Type: RADIATION

HDR brachytherapy

Interventions

Brachytherapy

HDR brachytherapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rafael Martínez-Monge, M.D.

Role: PRINCIPAL_INVESTIGATOR

Clinica Universidad de Navarra Cancer Center

Locations

Clínica Universidad de Navarra

Pamplona, Foral Community of Navarre, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Gabriel Canel, Ph.D.

Role: CONTACT

gcanel@unav.es

948255400 ext. 3300

Facility Contacts

Rafael Martínez-Monge, M.D.

Role: primary

rmartinezm@unav.es

948255400 ext. 5928

References

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.

Reference Type: BACKGROUND

PMID: 31629656 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30745145 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27160475 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22284039 (View on PubMed)

Other Identifiers

2020.212

Identifier Type: -

Identifier Source: org_study_id