Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial
Recruiting · NCT02391051 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Erlangen-Nürnberg Medical School
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This trial examines the feasibility and toxicity of focal brachytherapy in patients with low-risk prostate cancer.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- University Hospital - Erlangen, Germany