Focal Salvage Brachytherapy Study (FocaSaBra)

Recruiting now · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT05715502

Run by

The Greater Poland Cancer Centre

People needed

100

Starts

2022-05-01

Expected to finish

2028-12-31

Last updated by the study team

2025-04-30

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• PSA value> 10ng / ml
• General condition according to the WHO scale> 2
• Dysuria on the IPSS scale> 20 points
• PSA doubling time <6 months
• Inability to discontinue anticoagulants.
• An active urinary tract infection.
• Contraindications to general anesthesia
• Active inflammatory bowel diseases.
• Second active cancer or treatment with completion less than 3 years earlier, except for low-stage skin cancer
• Estimated Survival <5 years

Where it is running

• Greater Poland Cancer Centre / Brachytherapy Department — Poznan, Greater Poland Voivodeship, Poland (enrolling)

Full record on ClinicalTrials.gov

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