High Dose Rate Brachytherapy for Prostate Cancer Recurrence
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
Clinica Universidad de Navarra, Universidad de Navarra · NCT06982469
This study is testing if a special type of radiation treatment called High Dose Rate Brachytherapy can help men with prostate cancer that has come back after surgery feel better and have fewer side effects compared to regular radiation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Clinica Universidad de Navarra, Universidad de Navarra (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Pamplona, Foral Community of Navarre) |
| Trial ID | NCT06982469 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the long-term effects of High Dose Rate (HDR) Brachytherapy in men experiencing isolated local relapses of prostate cancer after radical prostatectomy. The study will compare HDR Brachytherapy with conventional external irradiation to determine if it improves control rates and reduces complications. Participants will receive HDR Brachytherapy as part of their standard medical care, combined with external beam radiation and androgen deprivation therapy to optimize treatment outcomes. The approach utilizes advanced imaging techniques to precisely target the affected areas while minimizing damage to surrounding tissues.
Who should consider this trial
Good fit: Ideal candidates are men with rising PSA levels and clinical evidence of isolated prostatic bed relapse that can be treated with HDR Brachytherapy.
Not a fit: Patients with distant metastases, isolated nodal relapses, or prior irradiation to the treatment area may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved cancer control and fewer side effects for patients with localized prostate cancer recurrence.
How similar studies have performed: Other studies have shown promising results with HDR Brachytherapy, suggesting potential benefits in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pamplona, Foral Community of Navarre
- Clínica Universidad de Navarra — Pamplona, Foral Community of Navarre, Spain (RECRUITING)
Study contacts
- Principal investigator: Rafael Martínez-Monge, M.D. — Clinica Universidad de Navarra Cancer Center
- Study coordinator: Gabriel Canel, Ph.D.
- Email: gcanel@unav.es
- Phone: 948255400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Prostatectomy, Local Recurrence of Malignant Tumor of Prostate, Radiotherapy, Complications, Brachytherapy