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

Recruiting now · Phase 2

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT02391051

Run by

University of Erlangen-Nürnberg Medical School

People needed

50

Starts

2014-10-01

Expected to finish

2029-12-01

Last updated by the study team

2017-08-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Tumor stage ≥ T2b
• Known metastasis: N+ and/or M1
• General anesthesia or peridural anesthesia is not possible
• Coagulation disorder

Where it is running

• University Hospital — Erlangen, Germany (enrolling)

Full record on ClinicalTrials.gov

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