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Quantitative mpMRI to Predict Metastatic Potential of Prostate Cancer (QmpMRI)

18 juni 2022 bijgewerkt door: Radboud University Medical Center
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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Verwacht)

30

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Mannelijk

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Case-Alleen
  • Tijdsperspectieven: Prospectief

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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.
Tijdsspanne: within 14 days of PSMA-PET/CT scan, before any therapy
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
the performance of individual quantitative MRI parameters discriminating localized from (oligo-)metastatic disease
Tijdsspanne: within 14 days of PSMA-PET/CT scan, before any therapy
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
MR parameters that correlate to the amount of metastases as found on PSMA-PET/CT
Tijdsspanne: within 14 days of PSMA-PET/CT scan, before any therapy
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
MR parameters that correlate to local prostate PSMA-PET intensity
Tijdsspanne: within 14 days of PSMA-PET/CT scan, before any therapy
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Radboud University Medical Center

Onderzoekers

  • Hoofdonderzoeker: Tom Scheenen, Radboud University Medical Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Verwacht)

1 juli 2022

Primaire voltooiing (Verwacht)

1 december 2022

Studie voltooiing (Verwacht)

1 maart 2023

Studieregistratiedata

Eerst ingediend

8 februari 2022

Eerst ingediend dat voldeed aan de QC-criteria

22 februari 2022

Eerst geplaatst (Werkelijk)

23 februari 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 juni 2022

Laatste update ingediend die voldeed aan QC-criteria

18 juni 2022

Laatst geverifieerd

1 februari 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NL77789.091.21

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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