Comparing PSMA PET/CT and MRI-RSI for Finding and Outlining Tumors Inside the Prostate in Men With Newly Diagnosed Prostate Cancer

NCT07568613 | Recruiting DMC

• 1 other identifier: ΕΕΒΚ/ΕΠ/2025/20
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (4)

• 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).

  24 months

• Absolute GTV volumes

  Conventional mpMRI, MRI-RSI and PSMA-PET derived absolute GTV volumes in ml

  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).

  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

  24 months

Secondary Outcomes (3)

• Dice Sorensen Coefficient (DSC)

  24 months

• Dose volume histogram parameters in volume (ml) in relation to Gray

  24 months

• Correlation coefficient (Spearman or Pearson)

  24 months

Study Arms (1)

Prospective comparison of PSMA PET/CT and MRI-RSI for patients with primary prostate cancer

EXPERIMENTAL

MRI-RSI imaging of the prostate (non-invasive)

Diagnostic Test: MRI; Diagnostic Test: 18F-PSMA1007 PET-CT; Diagnostic Test: MR-guided TRUS Prostate biopsy

Interventions

MRI DIAGNOSTIC_TEST

MRI-RSI imaging of the prostate (non-invasive)

Prospective comparison of PSMA PET/CT and MRI-RSI for patients with primary prostate cancer

18F-PSMA1007 PET-CT DIAGNOSTIC_TEST

PET scan according to standard protocol

Prospective comparison of PSMA PET/CT and MRI-RSI for patients with primary prostate cancer

MR-guided TRUS Prostate biopsy DIAGNOSTIC_TEST

Biopsy according to standard protocol

Prospective comparison of PSMA PET/CT and MRI-RSI for patients with primary prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: MALE
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• German Oncology Center, Cyprus: lead

Study Sites (1)

German Oncology Center

Limassol, 4108, Cyprus

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

CONSTANTINOS ZAMBOGLOU, DR

CONTACT

+35725208000; kristis.vevis@goc.com.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: May 6, 2026
• Study Start: August 18, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)