Focal Salvage Brachytherapy Study (FocaSaBra)
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorThe Greater Poland Cancer Centre
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
PSA value> 10ng / ml
General condition according to the WHO scale> 2
Dysuria on the IPSS scale> 20 points
PSA doubling time <6 months
Trial design
Treatments tested in this trial
- brachytherapy
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov