Tests focal radiation for prostate cancer that returned after earlier radiotherapy
Tests focal brachytherapy radiation for prostate cancer returning after prior radiotherapy in adults.
Plain-language title generated from the registry record
Registry title: Focal Salvage Brachytherapy Study (FocaSaBra)
Key facts
- Where
- Poznan, PolandSee the site
Where in Poland
- Greater Poland Cancer Centre / Brachytherapy DepartmentPoznan, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Greater Poland Cancer Centre
- Trial code
- NCT05715502
- Record updated
- 30 April 2025
- Original description
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.Read full original descriptionShow less
Assessment of the Toxicity of Focal Salvage Brachytherapy of Recurrent Prostate Cancer After Prior Radiotherapy - the Prospective Focal Salvage Brachytherapy Study (FocaSaBra)
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.
Inclusion: Histopathologically confirmed by biopsy (fusion mapping biopsy preferred) recurrence of prostate cancer after prior radical radiotherapy (brachytherapy, external beam radiotherapy alone or with brachytherapy boost, stereotaxic radiotherapy); Localized tumor lesion assessed by MRI or in the case of MR contraindications with TRUS and CT; Exclusion of distant metastases using CT, MR, or PET imaging; PSA doubling time over six months; PSA value <10 ng / ml; No anti-androgen treatment in the year prior; Dysuria on the IPSS (International Prostate Symptom Score) ≤ 20 points; General condition according to the WHO scale ≤ 2; Signing informed consent to participate in the study.
Exclusion: Second active cancer or treatment with completion less than 3 years earlier, except for low-stage skin cancer; General condition according to the WHO scale> 2; An active urinary tract infection; Active inflammatory bowel diseases; Estimated Survival <5 years; PSA value> 10ng / ml; Dysuria on the IPSS scale> 20 points; PSA doubling time <6 months; Inability to discontinue anticoagulants; Contraindications to general anesthesia.