Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT05715502

Focal Salvage Brachytherapy Study (FocaSaBra)

Led by The Greater Poland Cancer Centre · Updated on 2025-04-30

100

Participants Needed

1

Research Sites

348 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The aim of this prospective phase II study is to evaluate the toxicity of salvage partial (focal) prostate brachytherapy in patients after prior radiotherapy (standard teleradiotherapy with / without brachytherapy, hypofractionated, self-reactive HDR / LDR brachytherapy) with local recurrence on the part of the prostate gland.

CONDITIONS

Official Title

Focal Salvage Brachytherapy Study (FocaSaBra)

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Biopsy-confirmed local recurrence of prostate cancer after prior radical radiotherapy
  • Localized tumor seen on MRI or, if MRI is not possible, on TRUS and CT
  • No distant metastases confirmed by CT, MRI, or PET scans
  • PSA doubling time longer than six months
  • PSA level less than 10 ng/ml
  • No anti-androgen treatment in the past year
  • Urinary symptoms score (IPSS) 20 points or less
  • General health status (WHO scale) 2 or less
  • Signed informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • PSA value greater than 10 ng/ml
  • General health status (WHO scale) higher than 2
  • Urinary symptoms score (IPSS) greater than 20 points
  • PSA doubling time less than six months
  • Cannot stop anticoagulant medications
  • Active urinary tract infection
  • Cannot undergo general anesthesia
  • Active inflammatory bowel disease
  • Another active cancer or treatment completed less than 3 years ago (except low-stage skin cancer)
  • Estimated survival less than 5 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Greater Poland Cancer Centre / Brachytherapy Department

Poznan, Greater Poland Voivodeship, Poland, 61-866

Actively Recruiting

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Research Team

W

Wojciech Burchardt, PhD, MD

CONTACT

E

Ewa Tańska, PhD, MSc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Focal Salvage Brachytherapy Study (FocaSaBra) | DecenTrialz