Quantitative mpMRI to Predict Metastatic Potential of Prostate Cancer

Prostate Cancer Clinical Trial

— QmpMRI  

Official title:

Quantitative mpMRI to Predict Metastatic Potential of Prostate Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05252806
• Other study ID #: NL77789.091.21
• Status: Not yet recruiting
• Start date: July 2022
• Est. completion date: March 2023

Study information

• Verified date: February 2022
• Source: Radboud University Medical Center
• Contact: Carlijn Tenbergen
• Phone: +31 24 36 52285
• Email: carlijn.tenbergen[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Netherlands	Radboud university medical centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the performance of individual quantitative MRI parameters discriminating localized from (oligo-)metastatic disease	To test the individual quantitative MRI parameters for a significant difference between localized and (oligo-)metastatic disease, non-parametric tests for independent groups (Mann-Whitney U test) will be used. The ability of each parameter to discriminate between positive and negative PSMA-PET/CT is assessed using receiver operating characteristic curve analysis, which allows comparison to the logistic regression model performance.	within 14 days of PSMA-PET/CT scan, before any therapy
Secondary	MR parameters that correlate to the amount of metastases as found on PSMA-PET/CT	Participants with a positive PET/CT scan result will be divided in groups according to the number of positive lymph nodes detected (if variance within participants allows). To test for significant differences between these groups for each of the quantitative parameters, the non-parametric tests for multiple independent groups (Kruskal Wallis) will be used.	within 14 days of PSMA-PET/CT scan, before any therapy
Secondary	MR parameters that correlate to local prostate PSMA-PET intensity	To test for a correlation between the quantitative parameters and the local prostate PSMA-PET intensity, a spearmans rho test for correlation between two continuous variables will be used.	within 14 days of PSMA-PET/CT scan, before any therapy