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NCT Number: NCT07568613

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

German Oncology Center

Limassol, 4108, Cyprus

Location status: Recruiting

Location contact

CONSTANTINA CLOCONI

CONTACT

[email protected]

+35725208000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

MRI

Diagnostic Test

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

18F-PSMA1007 PET-CT

Diagnostic Test

PET scan according to standard protocol

MR-guided TRUS Prostate biopsy

Diagnostic Test

Biopsy according to standard protocol

Primary outcomes

  1. Sensitivity

    Time frame: 24 months

    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).

  2. Absolute GTV volumes

    Time frame: 24 months

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

  3. Specificity

    Time frame: 24 months

    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).

  4. ROC-AUC

    Time frame: 24 months

    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

Secondary outcomes

  1. Dice Sorensen Coefficient (DSC)

    Time frame: 24 months

    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.

  2. Dose volume histogram parameters in volume (ml) in relation to Gray

    Time frame: 24 months

    Comparison of planning parameters and DVH metrics after PSMA PET and/or MRI-RSI based radiotherapy for target volumes and organs at risk.

  3. Correlation coefficient (Spearman or Pearson)

    Time frame: 24 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

CONSTANTINOS ZAMBOGLOU, DR

CONTACT

[email protected]

+35725208000

Sponsors and collaborators

Lead sponsor

German Oncology Center, Cyprus

Other

Registry information

Official study title

Prospective Comparison of PSMA PET/CT and MRI-RSI (Restriction Spectrum Imaging) for Intraprostatic Tumor Detection and Delineation in Primary Prostate Cancer Patients

Acronym: PRIDE2-PC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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