NCT04790968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 28, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

3.4 years

First QC Date

March 5, 2021

Last Update Submit

November 13, 2024

Conditions

Prostatic NeoplasmsNeoplasm Metastasis

Keywords

Diagnostic imagingPositron-emission tomographyMagnetic Resonance ImagingProstate-specific antigenLymph NodesPSMAPETMolecular imaging

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month

Secondary Outcomes (2)

  • Sensitivity and specificity of PSMA PET/MRI

    1 month

  • Performance of PSMA PET/MRI versus PET/CT

    1 month

Study Arms (1)

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.

Diagnostic Test: PSMA-PETDiagnostic Test: PSMA-PET/MRIDiagnostic Test: PSMA-PET/CT

Interventions

PSMA-PETDIAGNOSTIC_TEST

Prostate specific membrane antigen positron emission tomography

PSMA-PET/MRI and PET/CT for detection of lymph node metastases.
PSMA-PET/MRIDIAGNOSTIC_TEST

Prostate specific membrane antigen positron emission tomography combined with magnetic resonance imaging

PSMA-PET/MRI and PET/CT for detection of lymph node metastases.
PSMA-PET/CTDIAGNOSTIC_TEST

Prostate specific membrane antigen positron emission tomography combined with computed tomography imaging

PSMA-PET/MRI and PET/CT for detection of lymph node metastases.

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Haukeland University Hospital

Bergen, Norway

Location

University Hosptial of North Norway

Tromsø, Norway

Location

St Olavs Hospital, Trondheim University Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Øystein Risa, Prof

    Norwegian University of Science and Technology, NTNU

    STUDY DIRECTOR

  • Morten Troøyen, MD

    St. Olavs Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 10, 2021

Study Start

April 28, 2021

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

November 15, 2024

Record last verified: 2024-11

Locations

NO(3)