Actively Recruiting
Comparing PSMA PET/CT and MRI-RSI for Finding and Outlining Tumors Inside the Prostate in Men With Newly Diagnosed Prostate Cancer
Led by German Oncology Center, Cyprus · Updated on 2026-05-06
50
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The detection and delineation of the intraprostatic tumor burden plays a crucial role in the personalized treatment of primary prostate cancer. The current gold standard multiparametric magnetic resonance imaging (mpMRI) is used to guide targeted prostate biopsies for initial diagnostic work up and for definitive focal dose-escalated radiotherapy in intermediate and high-risk prostate cancer patients. However, mpMRI might underestimate the tumor volume and manual gross tumor volume delineation based on mpMRI underlies significant interobserver variability. Thus, novel imaging modalities are warranted to increase the detection rate and/or decrease the interobserver variability during tumor delineation. This study will prospectively compare two promising advanced medical imaging methods: MRI-RSI and PSMA PET with the current gold-standard mpMRI for tumor detection and delineation in primary prostate cancer patients.
CONDITIONS
Official Title
Comparing PSMA PET/CT and MRI-RSI for Finding and Outlining Tumors Inside the Prostate in Men With Newly Diagnosed Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed and histologically confirmed primary prostate cancer
- NCCNv4.2024 risk groups: unfavorable intermediate risk, high-risk and very high-risk
- Males aged 18 years or older
- ECOG performance status between 0 and 2
- Estimated life expectancy of 5 years or more
- PSMA-PET/CT hybrid imaging performed within the last 3 months
- MRI-targeted biopsy on PIRADs v2.1 lesion 3 or higher performed within the last 6 months
You will not qualify if you...
- Contraindications for MRI imaging
- No visible tumor on PSMA PET and mpMRI (PIRADs v2.1 lesion 2 or lower)
- Transurethral resection of the prostate (TUR-P) performed less than 1 year ago
- Initial PSA level greater than 100 ng/ml
- History of cancer except localized skin tumors or cancer treated more than 5 years ago with no recurrence
- Previous radiation therapy to the pelvis
- Use of androgen deprivation therapy (ADT) or ADT plus other systemic therapy before inclusion
AI-Screening
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Trial Site Locations
Total: 1 location
1
German Oncology Center
Limassol, Cyprus, 4108
Actively Recruiting
Research Team
C
CONSTANTINOS ZAMBOGLOU, DR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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