NCT07568613Recruiting
Comparing PSMA PET/CT and MRI-RSI for Finding and Outlining Tumors Inside the Prostate in Men With Newly Diagnosed Prostate Cancer
Prospective Comparison of PSMA PET/CT and MRI-RSI (Restriction Spectrum Imaging) for Intraprostatic Tumor Detection and Delineation in Primary Prostate Cancer Patients
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 13 Aug 2025
- Start date
- 18 Aug 2025
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- German Oncology Center, Cyprus
- Diseases
- Prostate cancer
- NCT number
- NCT07568613
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 18 Aug 2025 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiation therapy to the pelvis
- ADT or ADT + other systemic therapy before inclusion
Age
- History of cancer (exception: localized skin tumours, tumours treated ≥5 years previously with curative intent and no evidence of recurrent disease)
Other
- Contraindications for MRI imaging
- No visible tumor on PSMA PET and mpMRI (defined by PIRADs v2.1 ≤2 lesion)
- TUR-P of the prostate \<1 year ago
- Initial PSA \>100 ng/ml
Who the study is looking for
- Newly diagnosed and histologically confirmed primary prostate cancer
- NCCNv4.2024 risk groups: unfavorable intermediate risk, high-risk and very high-risk
- Males, age ≥ 18 years
- ECOG performance status 0-2
- Estimated life expectancy ≥ 5 years
- PSMA-PET/CT-hybrid imaging performed \<3 months
- MRI-targeted biopsy on PIRADs v2.1 lesion ≥3 performed \<6 months
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| German Oncology Center Coordinator of this site? Confirm its status | Limassol | Cyprus | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.