Safety and Diagnostic Performance of uPAR PET Imaging in Localised, Untreated Prostate Cancer (uTRACE-101)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: 64Cu-DOTA-AE105

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Søren Fabricius; Phone Number: +45 22830160; Email: info@curasight.com

Study Locations

• Denmark
  • Aalborg, Denmark
    • Recruiting
    • Aalborg University Hospital
    • Contact: Prof. Zacho, MD,; Email: hzacho@dcm.aau.dk
    • Principal Investigator: Dr. Anne Buchhave Olsen
    • Sub-Investigator: Prof. Helle D. Zacho
  • Copenhagen
    • Herlev, Copenhagen, Denmark
      • Recruiting
      • Herlev & Gentofte Hospital
      • Contact: Dr. Rasmus Bisbjerg; Email: rasmus.bisbjerg@regionh.dk
      • Principal Investigator: Dr. Rasmus Bisbjerg
      • Sub-Investigator: Dr. Claus Madsen
  • Denmark
    • Vejle, Denmark, Denmark, 7100
      • Recruiting
      • Vejle Hospital
      • Contact: Bettina Nørby MD, PhD; Phone Number: +4579409420
      • Principal Investigator: Bettina Nørby MD
      • Sub-Investigator: Paw Holdgaard MD
• Germany
  • Chemnitz, Germany
    • Recruiting
    • Zeisigwaldkliniken Bethanien Chemnitz
    • Contact: Prof. Dr. Klaus Zöphel; Email: klaus.zoephel@skc.de
    • Principal Investigator: Prof. Dr. Klaus Zöphel
    • Sub-Investigator: Prof. Dr. Michael Fröhner
  • Düsseldorf, Germany
    • Recruiting
    • Universitätsklinikum, Düsseldorf
    • Contact: Prof. Dr. Frederik L Giesel; Email: frederik.giesel@med.uni-duesseldorf.de
    • Principal Investigator: Prof. Dr. Frederik Giesel
  • Hamburg, Germany
    • Recruiting
    • Martini-klinik am UKE
    • Contact: Prof. Dr. Tobias Maurer; Email: T.maurer@uke.de
    • Principal Investigator: Prof. Dr. Tobias Maurer
    • Sub-Investigator: Prof. Dr. Susanne Klutmann
  • Munich, Germany
    • Recruiting
    • Klinikum Rechts der Isar
    • Contact: Prof. Dr. Matthias Eiber; Email: matthias.eiber@tum.de
    • Principal Investigator: Prof. Dr. Matthias Eiber
    • Sub-Investigator: Prof. Dr. Thomas Horn
• Sweden
  • Gothenburg, Sweden, 41345
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Johan Stranne MD; Email: johan.stranne@vgregion.se
    • Sub-Investigator: Martijn van Essen, PhD
  • Skåne, Sweden, 20502
    • Recruiting
    • Skane University Hospital
    • Contact: Anders Bjartell MD; Email: anders.bjartell@med.lu.se
    • Principal Investigator: Prof. Dr. Anders Bjartell
    • Sub-Investigator: Prof. Dr. Elin Tragardh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 from enrolment into the trial.
  2. 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)

  1. The biopsy can be part of the primary staging, a confirmatory biopsy, or serial biopsy as part of an AS.
  2. 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:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 100 MBq 64Cu-DOTA-AE105; For Part 1 of the trial, 9 patients will receive 100 MBq 64Cu-DOTA-AE105 Day 1 and Day 8	Drug: 64Cu-DOTA-AE105; 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.
Experimental: 150 MBq 64Cu-DOTA-AE105; For Part 1 of the trial, 9 patients will receive 150 MBq 64Cu-DOTA-AE105 Day 1 and Day 8	Drug: 64Cu-DOTA-AE105; 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.
Experimental: 200 MBq 64Cu-DOTA-AE105; For Part 1 of the trial, 9 patients will receive 200 MBq 64Cu-DOTA-AE105 Day 1 and Day 8. For Part 2 of the trial, additional 141 patients will receive 200 Mbq 64Cu-DOTA-AE105	Drug: 64Cu-DOTA-AE105; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Standard uptake value (SUV) max at 30, 60, and 120 minutes post-injection (p.i.) - robustness	Part 1: mean of 3 independent readings of SUVmax at positron emission tomography (PET) aquisition times 30, 60, and 120 minutes p.1	Day 1
Part 2: SUVmax at 60 minutes p.i.	Part 2: mean of 3 independent readings of SUVmax at PET aquisition time 60 minutes p.i.	60 minutes post-injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: SUVmax in PET acquisitions at 60 minutes p.i.	Part 1: mean of 3 independent readings of SUVmax at PET aquisition time 60 minutes Day 1 and Day 8	Day 1 and Day 8
Part 1: Cmax from periodic radioactive counts from whole blood	Cmax from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples	Day 1
Part 1:Tmax from periodic radioactive counts from whole blood	Part 1: Tmax from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples	Day 1
Part 1: Area under curve (AUC) from periodic radioactive counts from whole blood	AUC from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples	Day 1
Part 1:Volume of distribution (Vd) from periodic radioactive counts from whole blood	Part 1: Vd from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples	Day 1
Part 1:Clearance from periodic radioactive counts from whole blood	Part 1: Clearance from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples	Day 1
Part 1: Elimination of 64Cu-DOTA-AE105 into a pooled urine sample	Part 1: Activity (MBq) per mL in urine samples pooled for the 3 hours following injection	Day 1
Part 1: Inter-reader variability of SUVmax	Part 1: Variability of 3 independent SUVmax readings at 30, 60, and 120-minutes p.i.	Day 1
Part 1:Intra-reader variability of SUVmax	Part 1: Variability of SUVmax readings at 30, 60, and 120-minutes p.i.	Day 1
Part 1: Inter-reader variation in tumour visibility	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.	Day 1
Part 1: Intra-reader variation in tumour visibility	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.	Day 1
Part 1: SUVmax using different acquisition durations	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	Day 1
Part 1: Variation in tumour visibility using different acquisition durations in the 200 MBq cohort	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	Day 1
Part 2: SUVmax variation between local and central readers	Part 2: mean of 3 central readers and read of 1 local reader of SUVmax in PET acquisitions at 60 minutes p.i.	60 minutes post-injection
Part 2: Tumour visibility in PET acquisitions	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.	60 minutes post injection
Part 2: Intra-reader variability of SUVmax	Part 2: Variability of SUVmax readings at 60-minutes p.i.	60 minutes post injection
Part 2: Inter-reader variability of SUVmax	Part 2: Variability of 3 independent SUVmax readings at 60 minutes p.i.	60 minutes post injection
Part 2: Inter-reader tumour visibility in PET acquisitions	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.	60 minutes post injection
Part 2: Intra-reader tumour visibility in PET acquisitions	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.	60 minutes post injection

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	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	Day 3

Collaborators and Investigators

• Sponsor: Curasight
• Collaborators: ABX CRO
• Investigators: Study Director: Prof. Dr. Andreas Kjær, Curasight

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 64Cu-DOTA-AE105-101; 2023-507111-35-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No