Quantitative mpMRI to Predict Metastatic Potential of Prostate Cancer

NCT ID: NCT05252806

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2023-03-31

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.

Detailed Description

Patients diagnosed with prostate cancer will likely not die from the primary tumor, but from (extended) metastatic disease. One of the first steps towards extended metastatic disease is the presence of lymph node metastases, which is an important factor in determining therapy and prognosis. Although historically all patients with lymph node metastases are considered incurable, research has shown that patients with only a limited number of small (<8 mm) nodal metastases have a better prognosis as compared to patients with more extensive involvement. In patients with only a limited number of small nodal metastases (oligo-metastatic), therapy with curative intent might be pursued, e.g. by surgical resection or loco-regional radiotherapy. With continuously improving opportunities to very selectively treat small numbers of metastatic sites it is of utmost importance to accurately diagnose the first signs of oligo-metastatic disease and to define its extent.

It is hypothesized that magnetic resonance imaging (MRI) can obtain more information from the local prostate than what is now used in the clinic to stage localized prostate cancer and oligo-metastatic disease. In recent years positron emission tomography (PET) in combination with computerized tomography (CT) and Prostate Specific Membrane Antigen (PSMA) tracers (PSMA-PET/CT) has emerged as an imaging modality to visualize (early) metastatic disease, but its accuracy in detecting oligo-metastatic spread is unknown, as small nodal metastases can be missed. In this study, the correlation is assessed between functional, quantitative and metabolic local tumor characteristics with PSMA-PET/CT-proven nodal involvement, to be able to predict metastatic potential from quantitative MRI parameters of the localized tumor. If the study shows potential for predicting presence of metastatic disease, future patients will benefit from improved nodal staging, potentially leading to more accurate and personalized treatment of the correct disease stage.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

MRI examination of the prostate

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tom Scheenen

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboud university medical centre

Nijmegen, , Netherlands

Countries

Netherlands

Central Contacts

Carlijn Tenbergen

Role: CONTACT

carlijn.tenbergen@radboudumc.nl

+31 24 36 52285

Tom Scheenen, Prof. Dr.

Role: CONTACT

tom.scheenen@radboudumc.nl

+31 24 36 13157

Facility Contacts

Carlijn Tenbergen

Role: primary

carlijn.tenbergen@radboudumc.nl

Other Identifiers

NL77789.091.21

Identifier Type: -

Identifier Source: org_study_id