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

NCT06474806 | Recruiting Phase 2

• 2 other identifiers: 64Cu-DOTA-AE105-1012023-507111-35-00
• Study Type: interventional
• Target: 168
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (19)

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

  Day 1 and Day 8

• Part 1: Cmax from periodic radioactive counts from whole blood

  Day 1

• Part 1:Tmax from periodic radioactive counts from whole blood

  Day 1

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

  Day 1

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

  Day 1

Other Outcomes (1)

• Incidence of adverse events

  Day 3

Study Arms (3)

100 MBq 64Cu-DOTA-AE105

EXPERIMENTAL

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

Drug: 64Cu-DOTA-AE105

150 MBq 64Cu-DOTA-AE105

EXPERIMENTAL

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

Drug: 64Cu-DOTA-AE105

200 MBq 64Cu-DOTA-AE105

EXPERIMENTAL

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

Interventions

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.

100 MBq 64Cu-DOTA-AE105; 150 MBq 64Cu-DOTA-AE105; 200 MBq 64Cu-DOTA-AE105

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Curasight: lead
• ABX CRO: collaborator

Study Sites (4)

Aalborg University Hospital

Aalborg, Denmark

RECRUITING

Vejle Hospital

Vejle, 7100, Denmark

RECRUITING

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

RECRUITING

Skåne University Hospital

Skåne, 20502, Sweden

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Andreas Kjær

  Curasight

  STUDY DIRECTOR

Central Study Contacts

Project Manager

CONTACT

+45 22830160; info@curasight.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 26, 2024
• Study Start: June 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2); SE (2)