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

Launched by UNIVERSITY OF ERLANGEN-NÜRNBERG MEDICAL SCHOOL · Mar 11, 2015

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called focal brachytherapy for men with low-risk prostate cancer. Focal brachytherapy involves placing tiny radioactive seeds directly into the tumor to help shrink or destroy it while minimizing damage to surrounding healthy tissue. The trial aims to see how safe this treatment is and whether it can be used effectively for patients who meet specific criteria.

To be eligible for this trial, participants must be men aged 18 or older with a confirmed diagnosis of prostate cancer that has a low likelihood of spreading. Key criteria include having a Gleason Score of 6 or less (which indicates a less aggressive cancer), a tumor that is limited in size, and a PSA level of 10 or lower. Participants can expect to undergo a procedure where these radioactive seeds are placed in their prostate, and they will be monitored for any side effects or complications. The trial is currently looking for new participants, and those interested should discuss with their healthcare provider to see if they qualify.

Gender

MALE

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 \< 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