High Dose Rate (HDR) Brachytherapy Salvage After Prostatectomy
Launched by CLINICA UNIVERSIDAD DE NAVARRA, UNIVERSIDAD DE NAVARRA · May 13, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a treatment called High Dose Rate (HDR) Brachytherapy for men who have prostate cancer that has come back in a specific area after surgery to remove the prostate (called a radical prostatectomy). The main goal is to find out if HDR Brachytherapy is better at controlling the cancer and causing fewer side effects compared to traditional external radiation therapy.
To be eligible for the trial, participants should be men aged 65 to 74 who have rising PSA levels (a marker for prostate cancer) and evidence of cancer returning in the area where the prostate was removed. They must also be able to undergo the HDR procedure safely. Participants will receive the HDR treatment as part of their regular care and will be closely monitored throughout the study to gather important information about the effectiveness and safety of this approach. If you or a loved one are considering participation, it's important to discuss this with your doctor to understand how it fits into your overall treatment plan.
Gender
MALE
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
About Clinica Universidad De Navarra, Universidad De Navarra
Clinica Universidad de Navarra, affiliated with Universidad de Navarra, is a leading academic medical center dedicated to advancing healthcare through innovative clinical research and patient care. With a commitment to excellence, it integrates cutting-edge medical research with comprehensive clinical services, fostering an environment that promotes the development of new therapies and treatment protocols. The institution is recognized for its robust clinical trial programs, which aim to enhance patient outcomes and contribute to the global medical community's knowledge. Through collaboration with various research entities and a focus on ethical standards, Clinica Universidad de Navarra plays a pivotal role in translating scientific discoveries into practical applications in medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Pamplona, Foral Community Of Navarre, Spain
Patients applied
Trial Officials
Rafael Martínez-Monge, M.D.
Principal Investigator
Clinica Universidad de Navarra Cancer Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported