Safety and Diagnostic Performance of uPAR PET Imaging in Localised, Untreated Prostate Cancer

Last updated: November 18, 2024
Sponsor: Curasight
Overall Status: Active - Recruiting

Phase

2

Condition

Prostate Cancer, Early, Recurrent

Prostate Disorders

Prostate Cancer

Treatment

64Cu-DOTA-AE105

Clinical Study ID

NCT06474806
64Cu-DOTA-AE105-101
2023-507111-35-00
  • Ages > 18
  • Male

Study Summary

The goal of this clinical trial is to test if the experimental agent accurately determines the aggressiveness of prostate cancer (biopsy-verified ISUP grade). The aim is that the diagnostic PET imaging agent may be used as an alternative or supplement to biopsies in the monitoring of patients with low-risk prostate cancer in active surveillance.

Patients diagnosed with untreated, low-grade, localized prostate cancer may participate in the trial. The experimental diagnostic agent 64Cu-DOTA-AE105 is a radiopharmaceutical which is injected into the veins and binds to uPAR expressing cells in the tumour which can then be visualized in a PET scanner.

The main question the trial aims to answer is: Can the test drug be used alone or as a supplement to repeated biopsies to accurately assess the aggressiveness of prostate cancer?

The trial is divided in 2 parts:

  • Participants in the first part will receive 2 injections of test drug on 2 different days.

    • The first day the participant will receive an injection of the test drug and then be asked to lie down in the PET/CT scanner so that images of the prostate can be taken. Before and after the injection/scanning procedure the participant will have tests done. These tests will include evaluation of health status, measurement of heart function by ECG plus blood and urine samples.

    • After 8 days the procedures, including injection of test drug and scanning, will be repeated.

  • Participants in the second part of the trial will only have 1 injection of the test drug and subsequent PET/CT scanning. Like in Part 1 of the trial, tests will be done before and after the injection/ scanning procedure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pathology-verified prostate adenocarcinoma

  • International Society of Urological Pathology (ISUP) grade 1 to 3

  • Localised prostate cancer (N0 and M0 status) (only required for ISUP 3 patients)

  1. Newly diagnosed patients: Staging must be performed within 6 months fromenrolment into the trial.

  2. Active surveillance: N0/M0 at the time of diagnosis and no clinical suspicionof prostate cancer outside the prostatic bed at the time of enrolment into thetrial.

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

  • Prostate biopsy within 1 to 6 months (patients with a biopsy within the last monthare excluded to avoid possible inflammation artefacts on the PET scan)

  1. The biopsy can be part of the primary staging, a confirmatory biopsy, or serialbiopsy as part of an AS.

  2. At least 1 core must be MRI-guided.

Exclusion

Exclusion Criteria:

  • Any prior treatment for prostate cancer (surgery, external beam radiation therapy,brachytherapy, hormone therapy, or chemotherapy)

  • Chronic prostatitis (any signs or symptoms of chronic bacterial prostatitis orchronic pelvic prostatitis and pain syndrome, or known diagnosis of asymptomaticinflammatory prostatitis)

  • Acute infections within the prostatic bed or lower urinary tract infections

  • Participants have inadequate bone marrow, kidney, liver, heart, or lung function:

Study Design

Total Participants: 168
Treatment Group(s): 1
Primary Treatment: 64Cu-DOTA-AE105
Phase: 2
Study Start date:
June 01, 2024
Estimated Completion Date:
September 01, 2025

Connect with a study center

  • Aalborg University Hospital

    Aalborg,
    Denmark

    Active - Recruiting

  • Vejle Hospital

    Vejle, 7100
    Denmark

    Active - Recruiting

  • Sahlgrenska University Hospital

    Goteborg, 41345
    Sweden

    Active - Recruiting

  • Skåne University Hospital

    Skåne, 20502
    Sweden

    Active - Recruiting

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