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

Curasight

Status and phase: Enrolling; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: 64Cu-DOTA-AE105

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06474806

64Cu-DOTA-AE105-101

2023-507111-35-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 168 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 3 patient groups

100 MBq 64Cu-DOTA-AE105

Experimental group

Description:

For Part 1 of the trial, 9 patients will receive 100 MBq 64Cu-DOTA-AE105 Day 1 and Day 8

Treatment:

Drug: 64Cu-DOTA-AE105

150 MBq 64Cu-DOTA-AE105

Experimental group

Description:

For Part 1 of the trial, 9 patients will receive 150 MBq 64Cu-DOTA-AE105 Day 1 and Day 8

Treatment:

Drug: 64Cu-DOTA-AE105

200 MBq 64Cu-DOTA-AE105

Experimental group

Description:

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

Treatment:

Drug: 64Cu-DOTA-AE105