Actively Recruiting
Image-guided Focal Dose Escalation- Primary pc Treated With Primary External Beam Hypofract.Stereotactic rt
Led by University Hospital Freiburg · Updated on 2024-03-26
374
Participants Needed
1
Research Sites
389 weeks
Total Duration
On this page
Sponsors
U
University Hospital Freiburg
Lead Sponsor
G
German Federal Ministry of Education and Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Image-guided Focal Dose Escalation- Primary pc Treated With Primary External Beam Hypofract.Stereotactic rt
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the prostate
- Primary localized prostate cancer (cN0 and cM0) with high-risk, very high-risk, or unfavorable intermediate-risk disease according to NCCN v2.2021
- Signed, written informed consent for the study
- Age over 18 years
- Completed PSMA-PET/CT and multiparametric MRI scans meeting standard prostate cancer requirements
- ECOG performance status score of 0 or 1
- International Prostate Symptom Score (IPSS) of 15 or less
- Prostate volume of 75 ml or less at radiation therapy planning
You will not qualify if you...
- Presence of neuroendocrine tumor cells
- Prior radiotherapy to the prostate or pelvis
- Prior radical prostatectomy
- Prior focal therapy to the prostate
- Time gap over 1 month between start of androgen deprivation therapy and imaging scans
- Radiologically suspicious or confirmed lymph node involvement (cN+) on imaging
- Evidence of metastatic disease (cM+) on imaging
- Evidence of cT4 disease on imaging
- PSA level over 30 ng/ml before starting androgen deprivation therapy
- Expected survival less than 5 years
- Bilateral hip prostheses or implants causing significant CT artifacts
- Contraindications to undergoing multiparametric MRI
- Prostate surgery with significant tissue cavity or surgery within last 6 months
- Medical conditions making radiotherapy inadvisable (e.g., acute inflammatory bowel disease, hemiplegia, paraplegia)
- Previous cancer within last 2 years except certain skin cancers or if expected to affect 5-year survival
- Contraindications to external beam radiotherapy to the pelvis
- No visible tumor on imaging scans
- Participation in other interventional clinical trials within 30 days prior
- Simultaneous participation in other interventional trials that could interfere
- Lack of legal capacity to understand the trial
- Known or persistent abuse of medication, drugs, or alcohol
- Expected severe problems with treatment setup
- Inability to meet dose constraints for organs at risk
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical Center - University of Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
Research Team
S
Sabine Schneider-Fuchs, DR
CONTACT
S
Sonja Adebahr, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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