Prostate CancerQmpMRINCT05252806
Quantitative mpMRI to Predict Metastatic Potential of Prostate Cancer
An observational study of Prostate Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MRI examination of the prostate
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2022to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud university medical centre
Nijmegen
Carlijn Tenbergen, carlijn.tenbergen@radboudumc.nl
About this study
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.
Read the 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
- Being tested
- MRI examination of the prostate
- Keywords
- Multiparametric Magnetic Resonance Imaging, Lymphatic Metastasis
- Medical subject headings
- Prostatic Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI examination of the prostateDiagnostic test
Participants will undergo one MRI examination of approximately 45 minutes including an intramuscular injection with an antispasmodic agent to minimize bowel movement
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: within 14 days of PSMA-PET/CT scan, before any therapy
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.
Measured: within 14 days of PSMA-PET/CT scan, before any therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study startJul 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tom Scheenen, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252806
- Sponsor's protocol ID
- NL77789.091.21
- Acronym
- QmpMRI
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative mpMRI to Predict Metastatic Potential of Prostate Cancer
- ClinicalTrials.gov ID
- NCT05252806
- Acronym / sponsor ID
- QmpMRI / NL77789.091.21
- Conditions
- Prostate Cancer
- Keywords
- Multiparametric Magnetic Resonance Imaging, Lymphatic Metastasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI examination of the prostateParticipants will undergo one MRI examination of approximately 45 minutes including an intramuscular injection with an antispasmodic agent to minimize bowel movement | Diagnostic test | – |
Primary outcome
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.
Time frame: 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.
3 secondary outcomes
the performance of individual quantitative MRI parameters discriminating localized from (oligo-)metastatic disease
Time frame: 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
Time frame: within 14 days of PSMA-PET/CT scan, before any therapy
MR parameters that correlate to local prostate PSMA-PET intensity
Time frame: within 14 days of PSMA-PET/CT scan, before any therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Scheenen principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlijn Tenbergen (+31 24 36 52285, carlijn.tenbergen@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: within 14 days of PSMA-PET/CT scan, before any therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.