Prostatic NeoplasmsNCT04790968
Combined PSMA PET/MRI for Detection of Lymph Node Metastases in High-risk Prostate Cancer Patients
A study testing PSMA-PET, PSMA-PET/MRI and PSMA-PET/CT in people with Prostatic Neoplasms and Neoplasm Metastasis, run by Norwegian University of Science and Technology at 3 sites in Norway.
Trial summary
For high-risk prostate cancer patients, detection of lymph node metastases is crucial to ensure optimal treatment. Standard treatment for these patients is radiotherapy or surgery. The surgery involves resection of the prostate and the pelvic lymph nodes. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms, Neoplasm Metastasis
- What is being tested?
- PSMA-PET, PSMA-PET/MRI and PSMA-PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesNorway
- Study dates
- 28 Apr 2021to 30 Sep 2024
- Phase
- Interventional
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- High risk localized/locally advanced prostate cancer patients who are candidates for radical prostatectomy plus bilateral extended PLND; ISUP Gleason grade group ≥ 4
- High-risk localized/locally advanced prostate cancer patients scheduled for radiation treatment of the prostate and pelvic lymph nodes; ISUP Gleason grade group ≥ 4
Who cannot join
- Prior history of any other cancer the last 5 years excluding basal cell carcinoma
- Proven metastases in bones or other distant metastases
- General contra-indications for MRI (pacemaker, aneurysm clips, any form of metal in the body, severe claustrophobia)
- Serious concomitant systemic disorders that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study objectives
- Metal implants in the pelvic region which will deteriorate PET/MR/CT image quality.
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Haukeland University Hospital
Bergen
University Hosptial of North Norway
Tromsø
St Olavs Hospital, Trondheim University Hospital
Trondheim
About this study
For high-risk prostate cancer patients, detection of lymph node metastases is crucial to ensure optimal treatment.
Standard treatment for these patients is radiotherapy or surgery. The surgery involves resection of the prostate and the pelvic lymph nodes. Currently, the most reliable method to confirm lymph node metastases is by histologic examination of the resected lymph nodes. Ideally, one should be able to detect lymph node metastases prior to treatment. Then, the treatment could be better adjusted to each patient.
Imaging methods such as prostate specific membrane antigen positron emission tomography (PSMA-PET) can possibly aid the detection of lymph node metastases. In this study, the investigators want to test whether PSMA-PET or a combination of PSMA-PET and MRI (magnetic resonance imaging) can improve staging of lymph nodes before treatment.
Read the detailed description
High-risk prostate cancer patients have a high probability for lymph node metastases in the pelvic region. The lymph node status is an important prognostic factor in determining the risk of later relapses and a factor in treatment planning. Lymph node metastases outside the pelvis usually signify systemic treatment not amendable for curative treatment.
High-risk prostate cancer patients are treated by radiotherapy or surgical resection of the prostate and the pelvic lymph nodes. Currently, the most reliable method for confirming lymph node metastases is by bilateral pelvic lymph node dissection during surgical treatment, and subsequent histologic examination. However, todays state-of-the art methods for the detection of lymph node metastases prior to treatment are clearly inadequate. Detection of lymph node metastases is crucial for determining whether the patient (i) is a candidate for localized treatment and, if so, (ii) optimizing the extent of the lymph node dissection / radiation field for localized treatment. Non-standard imaging methods such as prostate specific membrane antigen (PSMA)-PET-imaging have been shown to be able to aid in the detection of lymph node metastases. The purpose of this study is to test whether PSMA-PET or a combination of PSMA-PET and MRI can improve the sensitivity and specificity for pre-treatment lymph node staging in order to reduce both over- and undertreatment of high-risk prostate cancer patients.
In this multi-centre study, at least 80 patients with high-grade prostate cancer (according to NCNN Guidelines, v 2.2022) will be examined with PSMA PET/MRI and PET/CT. Study recruitment will continue until 60 patients have received radial prostatectomy with extended pelvic lymph node dissection (ePLND) (surgery cohort) and 20 patients have been treated with radiotherapy to the prostate and pelvic lymph nodes (radiotherapy cohort). After the PET examinations, all patients will receive standard treatment and follow-up, which is determined by national guidelines and the patient's treating urologist and/or oncologist. Imaging data will be analyzed by radiologists and nuclear medicine physicians in collaboration. The imaging findings in the surgery cohort will be compared to the histology outcome after ePLND to assess the sensitivity and specificity for detection of lymph node involvement with PSMA PET/MRI. The data from the radiotherapy cohort will be used to assess the feasibility of PSMA PET/MRI-based radiotherapy planning. Advanced image processing and analysis methodology including the use of artificial intelligence will also be applied.
- Conditions
- Prostatic Neoplasms, Neoplasm Metastasis
- Being tested
- PSMA-PET, PSMA-PET/MRI, PSMA-PET/CT
- Keywords
- Diagnostic imaging, Positron-emission tomography, Magnetic Resonance Imaging, Prostate-specific antigen, Lymph Nodes, PSMA, PET, Molecular imaging
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA-PETDiagnostic test
Prostate specific membrane antigen positron emission tomography
PSMA-PET/MRIDiagnostic test
Prostate specific membrane antigen positron emission tomography combined with magnetic resonance imaging
PSMA-PET/CTDiagnostic test
Prostate specific membrane antigen positron emission tomography combined with computed tomography imaging
| Study group | Role | What they receive |
|---|---|---|
| PSMA-PET/MRI and PET/CT for detection of lymph node metastases. | Experimental | Each patients will undergo an MRI-, PET/MRI- and PET/CT-examination (on the same day) prior to treatment.
Patients in the radiotherapy cohort will additionally undergo an MRI examination after hormonal treatment, before radiotherapy. Receives: Diagnostic Test: PSMA-PET; Diagnostic Test: PSMA-PET/MRI; Diagnostic Test: PSMA-PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of PSMA PET and combined PSMA PET/MRI
To compare the diagnostic accuracy of PSMA PET and combined PSMA PET/MRI to that of the current standard multiparametric MRI, using histopathology as the gold standard.
Measured: 1 month
Secondary outcomes (2)
Sensitivity and specificity of PSMA PET/MRI
To evaluate the sensitivity and specificity of PSMA PET/MRI to detect positive lymph nodes in high-risk prostate cancer patients in a prospective, multicenter study.
Measured: 1 month
Performance of PSMA PET/MRI versus PET/CT
Compare the performance of PET/MRI to PET/CT for detection of lymph node metastases
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start28 Apr 2021
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Haukeland University Hospital, University Hospital of North Norway
- Responsible party
- Sponsor
- Investigators
- Øystein Risa, Prof, Study director, Norwegian University of Science and Technology, NTNUMorten Troøyen, MD, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790968
- Sponsor's protocol ID
- REK 50719
- Status last verified
- Nov 2024
- First submitted
- 5 Mar 2021
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined PSMA PET/MRI for Detection of Lymph Node Metastases in High-risk Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT04790968
- Acronym / sponsor ID
- REK 50719
- Conditions
- Prostatic Neoplasms, Neoplasm Metastasis
- Keywords
- Diagnostic imaging, Positron-emission tomography, Magnetic Resonance Imaging, Prostate-specific antigen, Lymph Nodes, PSMA, PET, Molecular imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Haukeland University Hospital, University Hospital of North Norway
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 10 Mar 2021 (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.
For high-risk prostate cancer patients, detection of lymph node metastases is crucial to ensure optimal treatment.
Standard treatment for these patients is radiotherapy or surgery. The surgery involves resection of the prostate and the pelvic lymph nodes. Currently, the most reliable method to confirm lymph node metastases is by histologic examination of the resected lymph nodes. Ideally, one should be able to detect lymph node metastases prior to treatment. Then, the treatment could be better adjusted to each patient.
Imaging methods such as prostate specific membrane antigen positron emission tomography (PSMA-PET) can possibly aid the detection of lymph node metastases. In this study, the investigators want to test whether PSMA-PET or a combination of PSMA-PET and MRI (magnetic resonance imaging) can improve staging of lymph nodes before treatment.
Detailed description
High-risk prostate cancer patients have a high probability for lymph node metastases in the pelvic region. The lymph node status is an important prognostic factor in determining the risk of later relapses and a factor in treatment planning. Lymph node metastases outside the pelvis usually signify systemic treatment not amendable for curative treatment.
High-risk prostate cancer patients are treated by radiotherapy or surgical resection of the prostate and the pelvic lymph nodes. Currently, the most reliable method for confirming lymph node metastases is by bilateral pelvic lymph node dissection during surgical treatment, and subsequent histologic examination. However, todays state-of-the art methods for the detection of lymph node metastases prior to treatment are clearly inadequate. Detection of lymph node metastases is crucial for determining whether the patient (i) is a candidate for localized treatment and, if so, (ii) optimizing the extent of the lymph node dissection / radiation field for localized treatment. Non-standard imaging methods such as prostate specific membrane antigen (PSMA)-PET-imaging have been shown to be able to aid in the detection of lymph node metastases. The purpose of this study is to test whether PSMA-PET or a combination of PSMA-PET and MRI can improve the sensitivity and specificity for pre-treatment lymph node staging in order to reduce both over- and undertreatment of high-risk prostate cancer patients.
In this multi-centre study, at least 80 patients with high-grade prostate cancer (according to NCNN Guidelines, v 2.2022) will be examined with PSMA PET/MRI and PET/CT. Study recruitment will continue until 60 patients have received radial prostatectomy with extended pelvic lymph node dissection (ePLND) (surgery cohort) and 20 patients have been treated with radiotherapy to the prostate and pelvic lymph nodes (radiotherapy cohort). After the PET examinations, all patients will receive standard treatment and follow-up, which is determined by national guidelines and the patient's treating urologist and/or oncologist. Imaging data will be analyzed by radiologists and nuclear medicine physicians in collaboration. The imaging findings in the surgery cohort will be compared to the histology outcome after ePLND to assess the sensitivity and specificity for detection of lymph node involvement with PSMA PET/MRI. The data from the radiotherapy cohort will be used to assess the feasibility of PSMA PET/MRI-based radiotherapy planning. Advanced image processing and analysis methodology including the use of artificial intelligence will also be applied.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSMA-PET/MRI and PET/CT for detection of lymph node metastases. | Experimental | Diagnostic Test: PSMA-PET, Diagnostic Test: PSMA-PET/MRI, Diagnostic Test: PSMA-PET/CTEach patients will undergo an MRI-, PET/MRI- and PET/CT-examination (on the same day) prior to treatment. Patients in the radiotherapy cohort will additionally undergo an MRI examination after hormonal treatment, before radiotherapy. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- High risk localized/locally advanced prostate cancer patients who are candidates for radical prostatectomy plus bilateral extended PLND; ISUP Gleason grade group ≥ 4
- High-risk localized/locally advanced prostate cancer patients scheduled for radiation treatment of the prostate and pelvic lymph nodes; ISUP Gleason grade group ≥ 4
Key exclusion criteria (5 listed)
- Prior history of any other cancer the last 5 years excluding basal cell carcinoma
- Proven metastases in bones or other distant metastases
- General contra-indications for MRI (pacemaker, aneurysm clips, any form of metal in the body, severe claustrophobia)
- Serious concomitant systemic disorders that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study objectives
- Metal implants in the pelvic region which will deteriorate PET/MR/CT image quality.
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 |
|---|---|---|
| PSMA-PETProstate specific membrane antigen positron emission tomography | Diagnostic test | PSMA-PET/MRI and PET/CT for detection of lymph node metastases. |
| PSMA-PET/MRIProstate specific membrane antigen positron emission tomography combined with magnetic resonance imaging | Diagnostic test | PSMA-PET/MRI and PET/CT for detection of lymph node metastases. |
| PSMA-PET/CTProstate specific membrane antigen positron emission tomography combined with computed tomography imaging | Diagnostic test | PSMA-PET/MRI and PET/CT for detection of lymph node metastases. |
Primary outcome
Diagnostic accuracy of PSMA PET and combined PSMA PET/MRI
Time frame: 1 month
To compare the diagnostic accuracy of PSMA PET and combined PSMA PET/MRI to that of the current standard multiparametric MRI, using histopathology as the gold standard.
2 secondary outcomes
Sensitivity and specificity of PSMA PET/MRI
Time frame: 1 month
Performance of PSMA PET/MRI versus PET/CT
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
Øystein Risa, Prof study director
Norwegian University of Science and Technology, NTNU
Morten Troøyen, MD study director
St. Olavs Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSMA-PET, PSMA-PET/MRI and PSMA-PET/CT in people with Prostatic Neoplasms and Neoplasm Metastasis, run by Norwegian University of Science and Technology at 3 sites in Norway.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of PSMA PET and combined PSMA PET/MRI (time frame: 1 month). 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 15 Nov 2024.