Focal brachytherapy for low-risk prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the feasibility and toxicity of high-dose rate (HDR) brachytherapy in patients diagnosed with low-risk prostate cancer. Participants will receive two doses of 13.5 Gy of HDR brachytherapy. The study aims to determine the safety and effectiveness of this localized treatment approach for managing prostate cancer. A 3D-targeted prostate biopsy is required to confirm eligibility before treatment.

Why it matters

Who can join: the full rules

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's running

• University Hospital
  Erlangen, Germany Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.