Actively Recruiting

Age: 18Years - 80Years
MALE
ID06982469

MRI/PET PSMA-Based Study of Salvage HDR Brachytherapy and External Beam Radiation for Isolated Tumor Bed Relapses After Radical Prostatectomy

Led by Clinica Universidad de Navarra, Universidad de Navarra · Updated on 2025-06-19

20

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the long-term effects of high dose rate (HDR) brachytherapy in men who have isolated local relapses of prostate cancer after undergoing radical prostatectomy. The study aims to find out if HDR brachytherapy improves control rates and reduces complications compared to conventional external irradiation. This observational study focuses on men with prostate cancer recurrence visible on imaging and suitable for HDR brachytherapy. The treatment involves HDR brachytherapy combined with external beam radiation and six months of androgen deprivation therapy. HDR brachytherapy targets small, well-defined tumor areas using imaging techniques like PET/MRI and transrectal ultrasound guidance to deliver higher radiation doses while sparing sensitive surrounding tissues. This approach aims to reduce radiation exposure to critical structures such as the external urinary sphincter and penile bulb. Participants will receive HDR brachytherapy as part of their usual medical care and will be monitored for biochemical relapse-free survival over five years. The study includes regular imaging assessments, PSA monitoring, and evaluation of treatment effects and complications. The total participation period covers long-term follow-up to observe outcomes and safety in men treated for isolated prostate bed relapses after prostatectomy.

CONDITIONS

Brief Title

High Dose Rate (HDR) Brachytherapy Salvage After Prostatectomy

Who Can Participate

Age: 18Years - 80Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 18 to 80 years
  • Rising PSA after radical prostatectomy with clinical evidence of isolated prostatic bed relapse (IPBR) positive on PET PSMA/Choline and MRI
  • IPBR must be implantable via the transperineal route and visible on transrectal ultrasound
  • Pathological confirmation is advised but not mandatory
  • Ability to undergo brachytherapy MRI-based dosimetry
  • Written informed consent for investigational treatment and standard options
Not Eligible

You will not qualify if you...

  • Presence of distant metastases
  • Isolated nodal relapses
  • Prior irradiation to the isolated prostatic bed relapse area
  • Multiple isolated prostatic bed relapses (multicentric IPBRs)
  • Life expectancy less than 5 years or inability to tolerate and comply with HDR procedure

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 6 months

Participants receive HDR brachytherapy combined with external beam radiation and 6 months of androgen deprivation therapy to treat isolated prostatic bed relapse after prostatectomy.

Treatment visits as scheduled according to therapy protocol

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored for biochemical relapse-free survival and other outcomes after treatment completion.

Follow-up visits scheduled periodically over 5 years

Trial Site Locations

Total: 1 location

1

Clínica Universidad de Navarra

Pamplona, Foral Community of Navarre, Spain, 31008

Actively Recruiting

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Research Team

G

Gabriel Canel, Ph.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

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.

Christian Carrie, Nicolas Magné, Patricia Burban-Provost...

https://pubmed.ncbi.nlm.nih.gov/31629656

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.

Christian Carrie, Ali Hasbini, Guy de Laroche...

https://pubmed.ncbi.nlm.nih.gov/27160475

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.

Rafael Martínez-Monge, Marta Moreno, Raquel Ciérvide...

https://pubmed.ncbi.nlm.nih.gov/22284039