NCT05715502Recruiting
Focal Salvage Brachytherapy Study (FocaSaBra)
Assessment of the Toxicity of Focal Salvage Brachytherapy of Recurrent Prostate Cancer After Prior Radiotherapy - the Prospective Focal Salvage Brachytherapy Study (FocaSaBra)
Source: ClinicalTrials.gov · Last updated 30 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 13 Dec 2022
- Start date
- 1 May 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- The Greater Poland Cancer Centre
- Diseases
- Prostate cancer
- NCT number
- NCT05715502
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 May 2022 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Second active cancer or treatment with completion less than 3 years earlier, except for low-stage skin cancer
Other illness
- General condition according to the WHO scale\> 2
- An active urinary tract infection.
- Active inflammatory bowel diseases.
Age
- Estimated Survival \<5 years
Other
- PSA value\> 10ng / ml
- Dysuria on the IPSS scale\> 20 points
- PSA doubling time \<6 months
- Inability to discontinue anticoagulants.
- Contraindications to general anesthesia
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Greater Poland Cancer Centre / Brachytherapy Department Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.