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

NCT02391051 · tracked via the Priya Life Science Germany tracker

Sponsor

University of Erlangen-Nürnberg Medical School

Phase

Phase 2

Started

2014-10

Last updated

2017-08-11

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

HDR-Brachytherapy

HDR-Brachytherapy: HDR-Brachytherapy 2x 13,5 Gy

Study summary

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

Eligibility

Sex

MALE

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Intensity and frequency of adverse events — 6 weeks after therapy

Trial sites (1)

Facility	City	Region	Status
University Hospital	Erlangen	Germany	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02391051 on ClinicalTrials.gov ↗ ← All trials in Germany