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NCT Number: NCT06474806

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Herlev & Gentofte Hospital, Herlev, Copenhagen, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • Newly diagnosed patients: Staging must be performed within 6 months from enrolment into the trial.
  • Active surveillance: N0/M0 at the time of diagnosis and no clinical suspicion of prostate cancer outside the prostatic bed at the time of enrolment into the trial.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Prostate biopsy within 1 to 6 months (patients with a biopsy within the last month are excluded to avoid possible inflammation artefacts on the PET scan)
  • The biopsy can be part of the primary staging, a confirmatory biopsy, or serial biopsy as part of an AS.
  • At least 1 core must be MRI-guided.

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 or chronic pelvic prostatitis and pain syndrome, or known diagnosis of asymptomatic inflammatory prostatitis)
  • Acute infections within the prostatic bed or lower urinary tract infections
  • Participants have inadequate bone marrow, kidney, liver, heart, or lung function:

Treatment and study plan

64Cu-DOTA-AE105

Drug

AE105 is a uPAR-specific peptide that is bound to the chelator DOTA, which in turn holds the diagnostic radionuclide copper-64 (64Cu), which can be detected upon decay by PET imaging.

Primary outcomes

  1. Part 1: Standard uptake value (SUV) max at 30, 60, and 120 minutes post-injection (p.i.) - robustness

    Time frame: Day 1

    Part 1: mean of 3 independent readings of SUVmax at positron emission tomography (PET) aquisition times 30, 60, and 120 minutes p.1

  2. Part 2: SUVmax at 60 minutes p.i.

    Time frame: 60 minutes post-injection

    Part 2: mean of 3 independent readings of SUVmax at PET aquisition time 60 minutes p.i.

Secondary outcomes

  1. Part 1: SUVmax in PET acquisitions at 60 minutes p.i.

    Time frame: Day 1 and Day 8

    Part 1: mean of 3 independent readings of SUVmax at PET aquisition time 60 minutes Day 1 and Day 8

  2. Part 1: Cmax from periodic radioactive counts from whole blood

    Time frame: Day 1

    Cmax from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples

  3. Part 1:Tmax from periodic radioactive counts from whole blood

    Time frame: Day 1

    Part 1: Tmax from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples

  4. Part 1: Area under curve (AUC) from periodic radioactive counts from whole blood

    Time frame: Day 1

    AUC from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples

  5. Part 1:Volume of distribution (Vd) from periodic radioactive counts from whole blood

    Time frame: Day 1

    Part 1: Vd from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples

  6. Part 1:Clearance from periodic radioactive counts from whole blood

    Time frame: Day 1

    Part 1: Clearance from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples

  7. Part 1: Elimination of 64Cu-DOTA-AE105 into a pooled urine sample

    Time frame: Day 1

    Part 1: Activity (MBq) per mL in urine samples pooled for the 3 hours following injection

  8. Part 1: Inter-reader variability of SUVmax

    Time frame: Day 1

    Part 1: Variability of 3 independent SUVmax readings at 30, 60, and 120-minutes p.i.

  9. Part 1:Intra-reader variability of SUVmax

    Time frame: Day 1

    Part 1: Variability of SUVmax readings at 30, 60, and 120-minutes p.i.

  10. Part 1: Inter-reader variation in tumour visibility

    Time frame: Day 1

    Part 1: Tumor visibility in PET acquisitions evaluated by individual readings (numerical rating scale [NRS], 0-2 rating) at 30, 60, and 120 min p.i.

  11. Part 1: Intra-reader variation in tumour visibility

    Time frame: Day 1

    Part 1: Tumor visibility in PET acquisitions evaluated by individual readings (numerical rating scale [NRS], 0-2 rating) at 30, 60, and 120 min p.i.

  12. Part 1: SUVmax using different acquisition durations

    Time frame: Day 1

    Part 1: mean of 3 independent readings of SUVmax centered around 60 minutes p.i. in frame durations of 3-, 5-, 10-, 20-, 30-, and 40-minutes

  13. Part 1: Variation in tumour visibility using different acquisition durations in the 200 MBq cohort

    Time frame: Day 1

    Part 1: median of 3 central readings of tumor visibility (NRS, 0-2 rating), centered around 60 minutes p.i. in frame durations of 3-, 5-, 10-, 20-, 30-, and 40-minutes

  14. Part 2: SUVmax variation between local and central readers

    Time frame: 60 minutes post-injection

    Part 2: mean of 3 central readers and read of 1 local reader of SUVmax in PET acquisitions at 60 minutes p.i.

  15. Part 2: Tumour visibility in PET acquisitions

    Time frame: 60 minutes post injection

    Part 2: median of 3 central readings of tumor visibility (NRS, 0-2 rating) and read of 1 local reader in PET acquisitions at 60 minutes p.i.

  16. Part 2: Intra-reader variability of SUVmax

    Time frame: 60 minutes post injection

    Part 2: Variability of SUVmax readings at 60-minutes p.i.

  17. Part 2: Inter-reader variability of SUVmax

    Time frame: 60 minutes post injection

    Part 2: Variability of 3 independent SUVmax readings at 60 minutes p.i.

  18. Part 2: Inter-reader tumour visibility in PET acquisitions

    Time frame: 60 minutes post injection

    Part 2: individual readings by 3 central readers and 1 local reader of tumor visibility (NRS, 0-2 rating) in PET acquisitions at 60 minutes p.i.

  19. Part 2: Intra-reader tumour visibility in PET acquisitions

    Time frame: 60 minutes post injection

    Part 2: individual readings by 3 central readers and 1 local reader of tumor visibility (NRS, 0-2 rating) in PET acquisitions at 60 minutes p.i.

Other outcomes

  1. Incidence of adverse events

    Time frame: Day 3

    Part 2: Adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Søren Fabricius

CONTACT

[email protected]

+45 22830160

Sponsors and collaborators

Lead sponsor

Curasight

Industry

Collaborators

  • ABX CRO

Registry information

Official study title

An Open-label, Two-part, Phase 2 Clinical Trial to Investigate the Safety and Diagnostic Performance of uPAR PET Imaging for Non-invasive Classification of ISUP Grades Among Patients With Localised, Untreated Prostate Cancer.

Acronym: uTRACE-101

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2024
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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