Focal brachytherapy for low-risk prostate cancer
Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial
This study is testing a new type of targeted radiation treatment for men with low-risk prostate cancer to see if it's safe and effective.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Locations | 1 site (Erlangen) |
| Trial ID | NCT02391051 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men over 18 with histologically confirmed low-risk prostate cancer and specific tumor characteristics.
Not a fit: Patients with higher tumor stages, known metastasis, or coagulation disorders may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive and effective option for managing low-risk prostate cancer.
How similar studies have performed: Other studies have shown promise with brachytherapy approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Erlangen
- University Hospital — Erlangen, Germany (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.