NCT05252806

Quantitative mpMRI to Predict Metastatic Potential of Prostate Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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

Timeline

• Start date: 2022-07-01
• Primary completion: 2022-12-01
• Completion: 2023-03-01
• First posted: 2022-02-23
• Last updated: 2022-06-22

Locations

1 site across 1 country: Netherlands