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Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial

Recruiting
18 years of age
Male
Phase 2

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Overview

This trial examines the feasibility and toxicity of focal brachytherapy in patients with low-risk prostate cancer.

Description

Patients with low-risk prostate cancer will receive HDR-Brachytherapy: 2 x 13,5 Gy.

Eligibility

Inclusion Criteria:

  • Age > 18
  • Histologically confirmed prostate cancer
  • Gleason Score of index lesion ≤ 6 (3+3)
  • Tumor stage: cT1-2a cN0 cM0
  • Unilateral affection; index lesion ≤ 0.5ml with or without clinically non-significant lesion contralateral. No more than 25% of the punch should be affected. Therefore a 3D-TPM-biopsy is mandatory before treatment.
  • PSA ≤ 10/ng/ml
  • Prostate volume < 60 m^3
  • No distant metastasis
  • Life expectancy > 10 years
  • Informed consent

Exclusion Criteria:

  • Tumor stage ≥ T2b
  • Known metastasis: N+ and/or M1
  • General anesthesia or peridural anesthesia is not possible
  • Coagulation disorder

Study details

Prostate Cancer

NCT02391051

University of Erlangen-Nürnberg Medical School

25 January 2024

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