About this trial
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 body RT (reduction of treatment time) with a focal RT dose escalation on intraprostatic tumor sides by applying state of the art diagnostic imaging and most modern RT concepts. This novel concept will be compared with moderate hypofractionated RT (MHRT), one option for the curative primary treatment of PCa, which has been proven by several prospective trials and is recommended and carried out worldwide. We suspect an increase in relapse-free survival (RFS) and we will also assess quality of life in order to detect potential changes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
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)
Signed, written informed consent for HypoFocal-SBRT study
Disqualifiers
Evidence of neuroendocrine tumor cells
Prior radiotherapy to the prostate or pelvis
Prior radical prostatectomy
Prior focal therapy approaches to the prostate
Trial design
Parallel
Treatments tested in this trial
Radiotherapy (RT) Arm A - IMRT/IGRT/SBRT
Radiationtechnique: IMRT/IGRT/SBRT The HypoFocal-SBRT study combines ultra-hypofractionated RT / stereotactic body RT (reduction of treatment time) with a focal RT dose escalation on intraprostatic tumor sides by applying state of the art diagnostic imaging and most modern RT concepts.
Radiotherapy (RT) Arm B - IMRT/IGRT
Radiationtechnique: IMRT/IGRT Moderate hypofractionated RT (MHRT), one option for the curative primary treatment of PCa, which has been proven by several prospective trials and is recommended and carried out worldwide.
Treatment groups
Trial outcomes
Primary outcomes
Relapse free survival
Primary endpoint is relapse free survival (RFS), defined as time from randomization to relapse or death. Relapse free survival times will be censored at the time see last alive without relapse. Analysis will be conducted after finalization of the study.
Secondary outcomes
Time to local failure after randomization
Time to local failure after randomization. Local recurrences have to be confirmed by biopsy
Metastatic free survival after randomization
Metastatic free survival after randomization (all metastases have to be confirmed by imaging, preferably PSMA-PET/CT or mpMR imaging)
Overall (OS) and prostate cancer specific (PCSS) survival after randomization
Overall (OS) and prostate cancer specific (PCSS) survival after randomization
Time to biochemical failure (phoenix definition) after randomization
Time to biochemical failure (phoenix definition) after randomization
Sponsors and contacts
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University Hospital Freiburg
Lead sponsor
German Federal Ministry of Education and Research
Collaborator