NCT02391051 Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial
| NCT ID | NCT02391051 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Erlangen-Nürnberg Medical School |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2014-10 |
| Primary Completion | 2019-12 |
Trial Parameters
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Brief Summary
This trial examines the feasibility and toxicity of focal brachytherapy in patients with low-risk prostate cancer.
Eligibility Criteria
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
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