Image-guided Focal Dose Escalation in Patients With Primary Prostate Cancer Treated With Primary External Beam Hypofractionated Stereotactic Radiation Therapy (HypoFocal-SBRT) - a Prospective, Multicenter, Randomized Phase III Study

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

• 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)

• Signed, written informed consent for HypoFocal-SBRT study

• Age \> 18 years

• Previously conducted PSMA-PET/CT and mpMRI scans or PSMA-PET/MR, fulfilling standard requirements for PCa (see also 6.5)

• ECOG Performance score 0 or 1

• IPSS Score ≤15

• Prostate volume ≤75 ml at RT planning

Locations
Other Locations
Germany
Medical Center - University of Freiburg
RECRUITING
Freiburg Im Breisgau
Contact Information
Primary
Sabine Schneider-Fuchs, DR
sabine.schneider-fuchs@uniklinik-freiburg.de
+4976127074040
Backup
Sonja Adebahr, MD
sonja.adebahr@uniklinik-freiburg.de
+4976127095200
Time Frame
Start Date: 2022-08-18
Estimated Completion Date: 2030-02
Participants
Target number of participants: 374
Treatments
Experimental: Arm A - IMRT/IGRT/SBRT
Prostate and seminal vesicles RT with 30 Gy in 6 Gy / fraction; prostate RT with 35 Gy in 7 Gy / fraction including a simultaneous integrated boost (SIB) on the intraprostatic tumour mass (ITM) with 40- 42 Gy in 8 - 8.4 Gy / fraction.~If the boost volume is ≥10 ml and/ or ≥ 1/3 of the prostate, the SIB on the ITM has to be restrained to 40 Gy in 8 Gy / fraction. SBRT will be performed twice a week, with at least 2 days between two RT fractions, 5 fractions in 3 weeks (technique: IMRT/IGRT/SBRT).
Active_comparator: Arm B - IMRT/IGRT
Prostate and seminal vesicles RT with 46.4 Gy in 2.32 Gy per fraction, prostate RT with 60 and 62 Gy in 3 and 3.1 Gy per fraction for unfavorable intermediate-risk and high-risk patients, respectively, 20 fractions, 5 fractions /week, (technique: IMRT/IGRT).
Related Therapeutic Areas
Sponsors
Leads: University Hospital Freiburg
Collaborators: German Federal Ministry of Education and Research

This content was sourced from clinicaltrials.gov

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