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Recruiting
NCT05715502
Focal Salvage Brachytherapy Study (FocaSaBra)
Conditions: Prostate Cancer
Sex: Male
Ages: 18 Years – N/A
Phase: NA
Enrollment: 100
Sponsor: The Greater Poland Cancer Centre
Location: Poland
Summary
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
Inclusion Criteria: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 CTExclusion of distant metastases using CT, MR, or PET imagingPSA doubling time over six monthsPSA value <10 ng / mlNo anti-androgen treatment in the year priorDysuria on the IPSS (International Prostate Symptom Score) ≤ 20 pointsGeneral condition according to the WHO scale ≤ 2Signing informed consent to participate in the studyExclusion Criteria:PSA value> 10ng / mlGeneral condition according to the WHO scale> 2Dysuria on the IPSS scale> 20 pointsPSA doubling time <6 monthsInability to discontinue anticoagulants.An active urinary tract infection.Contraindications to general anesthesiaActive inflammatory bowel diseases.Second active cancer or treatment with completion less than 3 years earlier, except for low-stage skin cancerEstimated Survival <5 years
Source: ClinicalTrials.gov (NCT05715502). StuddyBuddy aggregates publicly available trial information.