Magnetic Resonance Imaging (MRI)/ Positron Emission Tomography (PET) Prostate-specific Membrane Antigen (PSMA) -Based Phase I-II Study of Salvage HDR Brachytherapy and External Beam Irradiation In Isolated Tumor Bed Relapses After Radical Prostatectomy

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Clínica Universidad de Navarra
RECRUITING
Pamplona
Contact Information
Primary
Gabriel Canel, Ph.D.
gcanel@unav.es
948255400
Time Frame
Start Date: 2020-05-05
Estimated Completion Date: 2030-05-01
Participants
Target number of participants: 20
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Clinica Universidad de Navarra, Universidad de Navarra

This content was sourced from clinicaltrials.gov