High Dose Rate Brachytherapy for Prostate Cancer Recurrence
Official title: 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
Run by Clinica Universidad de Navarra, Universidad de Navarra · NCT06982469 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | Men only |
| Enrollment | 20 (estimated) |
| Sponsor | Clinica Universidad de Navarra, Universidad de Navarra Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Pamplona, Foral Community of Navarre) |
| Status | Recruiting |
| Started | May 5, 2020 |
| Main results expected | May 1, 2026 |
| Study ends | May 1, 2030 |
| Registry record updated | June 19, 2025 |
| Trial ID | NCT06982469 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with distant metastases, isolated nodal relapses, or prior irradiation to the treatment area may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results with HDR Brachytherapy, suggesting potential benefits in similar patient populations.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing two types of radiation therapy for prostate cancer treatment
This study is testing whether a new type of radiation therapy for prostate cancer works better and is safer than a different method, while also looking at how well the treatment is tolerated by patients.
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Researchers will test whether a patient’s age, health history, and pre-surgery sexual function can predict erectile function after nerve-sparing robot-assisted prostatectomy.
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Prostate-first versus combined prostate and pelvic lymph node radiation dose escalation in PSMA PET–staged node-positive prostate cancer
This trial tests whether giving a stronger radiation boost to just the prostate first or to both the prostate and pelvic lymph nodes helps men whose prostate cancer has spread to nearby pelvic lymph nodes seen on PSMA PET.
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This study is testing a new device to see if it can help men with overactive bladder feel better after prostate surgery or radiation therapy.
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Personalized treatment for prostate cancer to improve quality of life after surgery
This study is testing whether a personalized treatment using apalutamide can help improve the quality of life and reduce fatigue for prostate cancer patients with detectable PSA levels after surgery, compared to standard therapy.
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Re-irradiation for local prostate cancer recurrences
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.