Prostate CancerPRIDE2-PCNCT07568613
Comparing PSMA PET/CT and MRI-RSI for Finding and Outlining Tumors Inside the Prostate in Men With Newly Diagnosed Prostate Cancer
A study testing MRI, 18F-PSMA1007 PET-CT and MR-guided TRUS Prostate biopsy in people with Prostate Cancer, run by German Oncology Center, Cyprus at 1 site in Cyprus.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MRI, 18F-PSMA1007 PET-CT and MR-guided TRUS Prostate biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCyprus
- Study dates
- 18 Aug 2025to 31 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- History of cancer (exception: localized skin tumours, tumours treated ≥5 years previously with curative intent and no evidence of recurrent disease)
- Previous radiation therapy to the pelvis
- ADT or ADT + other systemic therapy before inclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cyprus1 site, 1 recruiting
- Recruiting
German Oncology Center
Limassol, 4108
CONSTANTINA CLOCONI, +35725208000, constantina.cloconi@goc.com.cy
About this study
Official title: Prospective Comparison of PSMA PET/CT and MRI-RSI (Restriction Spectrum Imaging) for Intraprostatic Tumor Detection and Delineation in Primary Prostate Cancer Patients
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
- Prostate Cancer
- Being tested
- MRI, 18F-PSMA1007 PET-CT, MR-guided TRUS Prostate biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
MRI-RSI imaging of the prostate (non-invasive)
18F-PSMA1007 PET-CTDiagnostic test
PET scan according to standard protocol
MR-guided TRUS Prostate biopsyDiagnostic test
Biopsy according to standard protocol
| Study group | Role | What they receive |
|---|---|---|
| Prospective comparison of PSMA PET/CT and MRI-RSI for patients with primary prostate cancer | Experimental | MRI-RSI imaging of the prostate (non-invasive) Receives: Diagnostic Test: MRI; Diagnostic Test: 18F-PSMA1007 PET-CT; Diagnostic Test: MR-guided TRUS Prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity for PSMA PET, conventional mpMRI, MRI-RSI and combined modalities will be calculated on a prostate segment (n=6) level. The prostate cancer distribution in targeted biopsy cores will serve as the ground truth, calculated with the ratio of true positives to the total number of segments with the disease (true positives + false negatives).
Measured: 24 months
Absolute GTV volumes
Conventional mpMRI, MRI-RSI and PSMA-PET derived absolute GTV volumes in ml
Measured: 24 months
Specificity
Specificity for PSMA PET, conventional mpMRI, MRI-RSI and combined modalities will be calculated on a prostate segment (n=6) level. The prostate cancer distribution in targeted biopsy cores will serve as the ground truth, calculated with the ratio of true negatives to the total number of segments without the disease (true negatives + false positives).
Measured: 24 months
ROC-AUC
ROC-AUC for PSMA PET, conventional mpMRI, MRI-RSI and combined modalities on a segment level in comparison with prostate cancer distribution in targeted biopsy cores on a 6 segment level (ground truth). It will be calculated by integrating the area under the TPR (Sensitivity) vs FPR (1-Specificity) curve
Measured: 24 months
Secondary outcomes (3)
Dice Sorensen Coefficient (DSC)
The DSC is defined as followed: twice the size of the intersection of two sets, divided by the sum of the sizes of the two sets. The DSC will be used to compare different GTVs and likewise analyse the geometric overlap and the interobserver variance.
Measured: 24 months
Dose volume histogram parameters in volume (ml) in relation to Gray
Comparison of planning parameters and DVH metrics after PSMA PET and/or MRI-RSI based radiotherapy for target volumes and organs at risk.
Measured: 24 months
Correlation coefficient (Spearman or Pearson)
Quantitative imaging parameters from PSMA-PET, MRI-RSI and mpMRI images will be extracted and cross correlated with the ArteraAI MMAI test score (if available), Prolaris, the Ki-67 staining, the ISUP grade, serum PSA levels and the cTstage
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start18 Aug 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Oncology Center, Cyprus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568613
- Sponsor's protocol ID
- ΕΕΒΚ/ΕΠ/2025/20
- Acronym
- PRIDE2-PC
- Status last verified
- Apr 2026
- First submitted
- 13 Aug 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No