Clinical trial · Interventional
LDR Brachytherapy Versus SBRT for Low and Intermediate Risk Prostate Cancer Patients
LDR Brachytherapy Versus Hypofractionated SBRT for Low and Intermediate Risk Prostate Cancer Patients
NCT02895854CI-TRIAL-00050136BRAVEROBOunknownN/AClinicalTrials.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)
The aim of this trial is to find out if there are any differences in the profiles of acute and late adverse effects among men with low and intermediate risk prostate cancer treated either with low dose-rate brachytherapy or hypofractionated external radiotherapy (CyberKnife). Also the prostate specific antigen (PSA) responses and cost utility of each treatment will be analysed.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated RT 5 x 7,25 Gy | Radiation | — | UNRESOLVED |
| LDR-brachytherapy with I125 seeds | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- LDR-brachytherapy with I125 seeds
- description
- Low-dose rate-brachytherapy with I125 permanent seeds in prostate cancer.
- interventionNames
- Radiation: LDR-brachytherapy with I125 seeds
- type
- ACTIVE_COMPARATOR
- label
- Hypofractionated RT 5 x 7,25 Gy
- description
- Hypofractionated stereotactic radiotherapy 5 x 7,25 Gy delivered every second day in prostate cancer.
- interventionNames
- Radiation: Hypofractionated RT 5 x 7,25 Gy
Primary outcomes (1)
- measure
- Differences in acute adverse effects
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * biopsy proven adenocarcinoma of the prostate * Gleason score ≤ 3+4 * clinical and radiological TNM T1c-2c, N0-X, M0-X, PSA ≤ 20ng/ml and WHO 0-2 * low or intermediate risk prostate cancer according to National Comprehensive Cancer Network (NCCN) classification Exclusion Criteria: * clinical TNM ≥ T3 * Gleason score ≥ 4+3 * high risk prostate cancer according to NCCN classification * history of cancer (other than PC) during the past 5 years (excluding basalioma and squamocellular carcinoma of the skin) * previous pelvic radiotherapy * previous active treatments of prostate cancer (active surveillance allowed) * bilateral hip prothesis or other implant impedes pelvic TT or MRI imaging * clopidogrel medication * poor co-operation * life expectancy \< 5 yrs
References
Publications (0)
Data not yet available
No reference posted for this study.