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Focal Salvage Brachytherapy Study (FocaSaBra)

RecruitingNAAges 18 Years - anyMaleThe Greater Poland Cancer Centre
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 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) โ‰ค 20 points * General condition according to the WHO scale โ‰ค 2 * Signing informed consent to participate in the study Exclusion Criteria: * 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
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What it tests

  • brachytherapy
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Where

1 site
Greater Poland Cancer Centre / Brachytherapy Department
Poznan, Poland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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