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Prostate CancerPhase 2uTRACE-101NCT06474806

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

A Phase 2 study testing 64Cu-DOTA-AE105 in people with Prostate Cancer, run by Curasight at 9 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
64Cu-DOTA-AE105
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
9 sitesin 3 countries
Study dates
1 Jun 2024to 30 Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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:

Trial locations and contacts

9 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Søren Fabricius contact

+45 22830160

info@curasight.com

9 sites in 3 countries

Germany4 sites, 4 recruiting

  • Zeisigwaldkliniken Bethanien Chemnitz

    Chemnitz

    Prof. Dr. Klaus Zöphel, klaus.zoephel@skc.de

    Prof. Dr. Klaus Zöphel

    Recruiting

  • Universitätsklinikum, Düsseldorf

    Düsseldorf

    Prof. Dr. Frederik L Giesel, frederik.giesel@med.uni-duesseldorf.de

    Prof. Dr. Frederik Giesel

    Recruiting

  • Martini-klinik am UKE

    Hamburg

    Prof. Dr. Tobias Maurer, T.maurer@uke.de

    Prof. Dr. Tobias Maurer

    Recruiting

  • Klinikum rechts der Isar

    Munich

    Prof. Dr. Matthias Eiber, matthias.eiber@tum.de

    Prof. Dr. Matthias Eiber

    Recruiting

Other trials in Germany

Denmark3 sites, 3 recruiting

  • Aalborg University Hospital

    Aalborg

    Prof. Zacho, MD,, hzacho@dcm.aau.dk

    Dr. Anne Buchhave Olsen

    Recruiting

  • Herlev & Gentofte Hospital

    Herlev, Copenhagen

    Dr. Rasmus Bisbjerg, rasmus.bisbjerg@regionh.dk

    Dr. Rasmus Bisbjerg

    Recruiting

  • Vejle Hospital

    Vejle, Denmark, 7100

    Bettina Nørby MD, PhD, +4579409420

    Bettina Nørby MD

    Recruiting

Other trials in Denmark

Sweden2 sites, 2 recruiting

  • Sahlgrenska University Hospital

    Gothenburg, 41345

    Johan Stranne MD, johan.stranne@vgregion.se

    Martijn van Essen, PhD

    Recruiting

  • Skåne University Hospital

    Skåne, 20502

    Anders Bjartell MD, anders.bjartell@med.lu.se

    Prof. Dr. Anders Bjartell

    Recruiting

Other trials in Sweden

About this study

Official 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.

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.

Read more

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.
Conditions
Prostate Cancer
Being tested
64Cu-DOTA-AE105
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 64Cu-DOTA-AE105Drug

    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.

Study groups in NCT06474806
Study groupRoleWhat they receive
100 MBq 64Cu-DOTA-AE105ExperimentalFor Part 1 of the trial, 9 patients will receive 100 MBq 64Cu-DOTA-AE105 Day 1 and Day 8
Receives: Drug: 64Cu-DOTA-AE105
150 MBq 64Cu-DOTA-AE105ExperimentalFor Part 1 of the trial, 9 patients will receive 150 MBq 64Cu-DOTA-AE105 Day 1 and Day 8
Receives: Drug: 64Cu-DOTA-AE105
200 MBq 64Cu-DOTA-AE105ExperimentalFor 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
Receives: Drug: 64Cu-DOTA-AE105

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 1

  2. 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.

    Measured: 60 minutes post-injection

Secondary outcomes (19)

  1. 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

    Measured: Day 1 and Day 8

  2. 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

    Measured: Day 1

  3. 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

    Measured: Day 1

  4. 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

    Measured: Day 1

  5. 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

    Measured: Day 1

  6. 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

    Measured: Day 1

  7. 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

    Measured: Day 1

  8. Part 1: Inter-reader variability of SUVmax

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

    Measured: Day 1

  9. Part 1:Intra-reader variability of SUVmax

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

    Measured: Day 1

  10. 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.

    Measured: Day 1

  11. 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.

    Measured: Day 1

  12. 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

    Measured: Day 1

  13. 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

    Measured: Day 1

  14. 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.

    Measured: 60 minutes post-injection

  15. 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.

    Measured: 60 minutes post injection

  16. Part 2: Intra-reader variability of SUVmax

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

    Measured: 60 minutes post injection

  17. Part 2: Inter-reader variability of SUVmax

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

    Measured: 60 minutes post injection

  18. 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.

    Measured: 60 minutes post injection

  19. 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.

    Measured: 60 minutes post injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2024
  2. Study start1 Jun 2024
  3. Primary completion30 Jan 2027 (estimated)
  4. Study completion30 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
The trial consist on 2 parts: Part 1 will evaluate 3 different doses of 64Cu-DOTA-AE105 in parallel (100, 150, or 200 MBq) in 27 patients (randomized 1:1:1) . Part 2 will evaluate 1 dose of 64Cu-DOTA-AE105 (200 MBq) in 141 patients
Masking
None (open label)
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06474806
Sponsor's protocol ID
64Cu-DOTA-AE105-101
Other IDs
2023-507111-35-00, 2023
Acronym
uTRACE-101
Status last verified
May 2026
First submitted
6 Jun 2024
Last updated
1 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 64Cu-DOTA-AE105 in people with Prostate Cancer, run by Curasight at 9 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Germany, Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Søren Fabricius (+45 22830160, info@curasight.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Standard uptake value (SUV) max at 30, 60, and 120 minutes post-injection (p.i.) - robustness (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06474806.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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