Focal Brachytherapy in Patients With Selected “Low-risk” Prostate Cancer – a Phase-II-trial
Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial
About This Trial
- This study is testing a targeted radiation treatment that places tiny radioactive implants directly into the cancerous area of the prostate, rather than treating the entire gland.
- Researchers want to see if this focused approach is safe and causes fewer side effects for patients.
- The trial is designed for adults with early-stage, low-risk prostate cancer that is small and has not spread beyond a limited area.
- Before joining, patients will need a specialized mapping biopsy to confirm the exact location of the tumor and must be healthy enough to safely receive anesthesia for the procedure.
More Information
- This trial examines the feasibility and toxicity of focal brachytherapy in patients with low-risk prostate cancer.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is testing a targeted radiation treatment that places tiny radioactive implants directly into the cancerous area of the prostate, rather than treating the entire gland.
Study Details
- Start Date: October 2014
- Lead Sponsor: University of Erlangen-Nürnberg Medical School
Full Eligibility Criteria
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 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
Treatments
- Radiation: HDR-Brachytherapy