Image-guided Focal Dose Escalation- Primary pc Treated With Primary External Beam Hypofrac
Technical advances in radiotherapy (RT) treatment planning and delivery have substantially changed RT concepts for primary prostate cancer (PCa) by (i) enabling a reduction of treatment time and by (ii) enabling a safe delivery of high RT doses. Several studies proposed a dose-response relationship for patients with pr
| Condition(s) | Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Technical advances in radiotherapy (RT) treatment planning and delivery have substantially changed RT concepts for primary prostate cancer (PCa) by (i) enabling a reduction of treatment time and by (ii) enabling a safe delivery of high RT doses. Several studies proposed a dose-response relationship for patients with primary prostate cancer (PCa) and especially in patients with high-risk features a dose escalation should lead to improved tumor control. In parallel to the improvements in RT techniques, diagnostic imaging techniques like multiparametric magnetic resonance imaging (mpMRI) and positron-emission tomography (PET) evolved and enable an accurate depiction of the intraprostatic tumor mass for the first time. The HypoFocal-SBRT study combines ultra-hypofractionated RT / stereotactic |
| Who can participate | Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the prostate (histological confirmation can be based on tissue taken at any time, but a re-biopsy should be considered if the biopsy is more than 12 months old) 2. Primary localized PCa (cN0 and cM0 in mpMRI and PSMA PET): * high- or very high-risk according to NCCN v2.2021 (see 20.3) OR * unfavorable intermediate-risk disease according to NCCN v2.2021 (see 20.3) 3. Signed, written informed consent for HypoFocal-SBRT study 4. Age \> 18 years 5. Previously conducted PSMA-PET/CT and mpMRI scans or PSMA-PET/MR, fulfilling standard requirements for PCa (see also 6.5) 6. ECOG Performance score 0 or 1 7. IPSS Score ≤15 8. Prostate volume ≤75 ml at RT planning Exclusion Criteria: 1. Evidence of neuroendocrine tumor cells 2. Prior r |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | University Hospital Freiburg |
| Locations | Freiburg im Breisgau, Baden-Wurttemberg, Germany |
| Start date | 2022-08-18 |
| NCT ID | NCT06330909 |
| Official listing | https://clinicaltrials.gov/study/NCT06330909 |