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

RECRUITINGPhase 2Sponsored by University of Erlangen-Nürnberg Medical School
Actively Recruiting
PhasePhase 2
SponsorUniversity of Erlangen-Nürnberg Medical School
Started2014-10
Est. completion2019-12
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT02391051

Summary

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

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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

Conditions2

CancerProstate Cancer

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