Quantitative mpMRI to Predict Metastatic Potential of Prostate Cancer

NCT05252806 | Unknown

• 1 other identifier: NL77789.091.21
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to assess the potential of quantitative MRI measurements to predict localized prostate cancer T-stage and disease spread to nodes (N-stage) by correlating quantitative MRI measurements of the local prostate to the presence of metastases as seen on PSMA-PET/CT.

Conditions

Prostate Cancer

Keywords

Multiparametric Magnetic Resonance Imaging; Lymphatic Metastasis

Outcome Measures

Primary Outcomes (1)

• optimal combination of quantitative MRI parameters that best correlates to the presence of (lymph node) metastases in prostate cancer as seen on PSMA-PET/CT.

  To find the optimal combination of quantitative parameters for discriminating between positive and negative PSMA-PET/CT, logistic regression modelling will be used. The performance of the model will be evaluated using receiver operating characteristic curve analysis.

  within 14 days of PSMA-PET/CT scan, before any therapy

Secondary Outcomes (3)

• the performance of individual quantitative MRI parameters discriminating localized from (oligo-)metastatic disease

  within 14 days of PSMA-PET/CT scan, before any therapy

• MR parameters that correlate to the amount of metastases as found on PSMA-PET/CT

  within 14 days of PSMA-PET/CT scan, before any therapy

• MR parameters that correlate to local prostate PSMA-PET intensity

  within 14 days of PSMA-PET/CT scan, before any therapy

Interventions

MRI examination of the prostate DIAGNOSTIC_TEST

Participants will undergo one MRI examination of approximately 45 minutes including an intramuscular injection with an antispasmodic agent to minimize bowel movement

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients, diagnosed with prostate cancer by prostate biopsy and having a high risk of nodal metastases, will be recruited at the Radboudumc in Nijmegen. This research population will be a suitable reflection of the potential patient group who will eventually benefit from this new diagnostic mpMRI approach, in case the results match the hypothesis. Characteristics of this group will comprise all men with an expected age in the range of 50-75 years. Patients will be informed about the ongoing study by their treating physician. Patients will receive the patient information folder and will be contacted by one of the researchers. Upon approval, informed consent paperwork will be handed.

You may qualify if:

• Histologically proven primary cancer of the prostate, based on prostate biopsy-core analysis.
• Patient is scheduled and fit for PSMA-PET/CT
• Age≥50 years. Ability to give voluntary written informed consent to participate in this study.

You may not qualify if:

• Contraindication for MRI-scanning, i.e. claustrophobia, intracranial metal clips, metallic bodies in the eye, implanted electric and electronic devices not eligible for MRI (pacemakers, insulin pumps, cochlear implants, neurostimulators).
• Prior prostate cancer treatment.
• Prior pelvic surgery, associated with pelvic lymphadenopathy
• Presence of any medical condition that in the opinion of the investigator/treating physician will affect patients' clinical status by participating in this trial.
• Inability to lie still for 45 minutes or comply with imaging.
• The patient is already enrolled in one or more concurrent studies, which could confound the results of this study, according to the investigators.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud university medical centre

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tom Scheenen

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlijn Tenbergen

CONTACT

+31 24 36 52285; carlijn.tenbergen@radboudumc.nl

Tom Scheenen, Prof. Dr.

CONTACT

+31 24 36 13157; tom.scheenen@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 23, 2022
• Study Start: July 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: June 22, 2022

Record last verified: 2022-02

Locations

NL (1)