Clinical trial · Interventional
Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial
NCT02391051CI-TRIAL-00029047FOKAL-BTrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial examines the feasibility and toxicity of focal brachytherapy in patients with low-risk prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HDR-Brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Focal Brachytherapy
- description
- HDR-Brachytherapy, 2 fractions within at least 24 but max. 30 hours, each 13,5 Gy
- interventionNames
- Radiation: HDR-Brachytherapy
Primary outcomes (1)
- measure
- Intensity and frequency of adverse events
- timeFrame
- 6 weeks after therapy
Secondary outcomes (5)
- measure
- Tumor regression
- timeFrame
- 6 weeks up to 10 years after therapy
- measure
- Rate of recurrences measured by PSA
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.