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

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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

Tracking Information
First Submitted Date  ICMJE March 5, 2021
First Posted Date  ICMJE March 10, 2021
Last Update Posted Date August 15, 2023
Actual Study Start Date  ICMJE April 28, 2021
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2021)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2021)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined PSMA PET/MRI for Detection of Lymph Node Metastases in High-risk Prostate Cancer Patients
Official Title  ICMJE Combined PSMA PET/MRI for Detection of Lymph Node Metastases in High-risk Prostate Cancer Patients
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Prostatic Neoplasms
  • Neoplasm Metastasis
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.

Interventions:
  • Diagnostic Test: PSMA-PET
  • Diagnostic Test: PSMA-PET/MRI
  • Diagnostic Test: PSMA-PET/CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 5, 2021)		 80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04790968
Other Study ID Numbers  ICMJE REK 50719
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Norwegian University of Science and Technology
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Norwegian University of Science and Technology
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • St. Olavs Hospital
  • Haukeland University Hospital
  • University Hospital of North Norway
Investigators  ICMJE
Study Director: Øystein Risa, Prof Norwegian University of Science and Technology, NTNU
Study Director: Morten Troøyen, MD St. Olavs Hospital
PRS Account Norwegian University of Science and Technology
Verification Date August 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP