NCT02391051RecruitingPhase 2
Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial
Source: ClinicalTrials.gov · Last updated 11 Aug 2017 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This trial examines the feasibility and toxicity of focal brachytherapy in patients with low-risk prostate cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 1 Jul 2014
- Start date
- Oct 2014
- Primary completion date
- Dec 2019
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Diseases
- Prostate cancer
- NCT number
- NCT02391051
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From Oct 2014 to the primary completion date, Dec 2019
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Coagulation disorder
Other
- Tumor stage ≥ T2b
- Known metastasis: N+ and/or M1
- General anesthesia or peridural anesthesia is not possible
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Coordinator of this site? Confirm its status | Erlangen | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.