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Combined PSMA PET/MRI for Detection of Lymph Node Metastases in High-risk Prostate Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04790968
Recruitment Status : Recruiting
First Posted : March 10, 2021
Last Update Posted : August 15, 2023
Sponsor:
Collaborators:
St. Olavs Hospital
Haukeland University Hospital
University Hospital of North Norway
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Neoplasm Metastasis Diagnostic Test: PSMA-PET Diagnostic Test: PSMA-PET/MRI Diagnostic Test: PSMA-PET/CT Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Combined PSMA PET/MRI for Detection of Lymph Node Metastases in High-risk Prostate Cancer Patients
Actual Study Start Date : April 28, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: PSMA-PET/MRI and PET/CT for detection of lymph node metastases.

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.

 Diagnostic Test: PSMA-PET
Prostate specific membrane antigen positron emission tomography

Diagnostic Test: PSMA-PET/MRI
Prostate specific membrane antigen positron emission tomography combined with magnetic resonance imaging

Diagnostic Test: PSMA-PET/CT
Prostate specific membrane antigen positron emission tomography combined with computed tomography imaging


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Sensitivity and specificity of PSMA PET/MRI [ Time Frame: 1 month ]
    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.

  2. Performance of PSMA PET/MRI versus PET/CT [ Time Frame: 1 month ]
    Compare the performance of PET/MRI to PET/CT for detection of lymph node metastases


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria (surgery cohort):

  • High risk localized/locally advanced prostate cancer patients who are candidates for radical prostatectomy plus bilateral extended PLND; ISUP Gleason grade group ≥ 4

Inclusion criteria (radiotherapy cohort):

  • High-risk localized/locally advanced prostate cancer patients scheduled for radiation treatment of the prostate and pelvic lymph nodes; ISUP Gleason grade group ≥ 4

Exclusion criteria (surgery and radiotherapy cohort):

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04790968


Contacts
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Contact: Tone Frost Bathen, prof 95021097 ext 0047 tone.f.bathen@ntnu.no
Contact: Ingerid Skjei Knudtsen, PhD 47393211 ext 0047 ingerid.s.knudtsen@ntnu.no

Locations
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Norway
Haukeland University Hospital Recruiting
Bergen, Norway
Contact: Alfred Honoré, MD, PhD    94282796 ext 0047    alfred.honore@helse-bergen.no   
Contact: Kristina Førde    55974723 ext 0047    kristina.forde@helse-bergen.no   
University Hosptial of North Norway Recruiting
Tromsø, Norway
Contact: Hege S Haugnes, MD, PhD    99277080 ext 0047    hege.sagstuen.haugnes@unn.no   
St Olavs Hospital, Trondheim University Hospital Recruiting
Trondheim, Norway
Contact: Torgrim Tandstad, MD, PhD    72826166 ext 0047    torgrim.tandstad@stolav.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Haukeland University Hospital
University Hospital of North Norway
Investigators
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Study Director: Øystein Risa, Prof Norwegian University of Science and Technology, NTNU
Study Director: Morten Troøyen, MD St. Olavs Hospital
More Information
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT04790968    
Other Study ID Numbers: REK 50719
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: August 15, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Diagnostic imaging
Positron-emission tomography
Magnetic Resonance Imaging
Prostate-specific antigen
 Lymph Nodes
PSMA
PET
Molecular imaging
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms
Neoplasm Metastasis
Lymphatic Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Neoplastic Processes
Pathologic Processes