Image-guided Focal Dose Escalation- Primary pc Treated With Primary External Beam Hypofract.Stereotactic rt

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity Hospital Freiburg

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

Qualifiers

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

Treatments tested in this trial

  • Radiotherapy (RT) Arm A - IMRT/IGRT/SBRT
  • Radiotherapy (RT) Arm B - IMRT/IGRT

Treatment groups

374 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital Freiburg

Lead sponsor

German Federal Ministry of Education and Research

Collaborator