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Recruiting Phase 2

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

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About this study

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.

Condition
Prostate Cancer
Tested
64Cu-DOTA-AE105
Sponsor
Curasight

Who can join

Age
18 years and older
Sex
Male only
Healthy volunteers
Not accepted

Inclusion 12

  • Minimum age: 18 years
  • Eligible sex: Male
  • Study condition: Prostate Cancer
  • 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 4

  • 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:

Where

9 sites, 9 recruiting

Aalborg University Hospital

Aalborg, Denmark

Recruiting

Herlev & Gentofte Hospital

Herlev, Copenhagen, Denmark

Recruiting

Vejle Hospital

Vejle, Denmark, Denmark

Recruiting

Zeisigwaldkliniken Bethanien Chemnitz

Chemnitz, Germany

Recruiting

Universitätsklinikum, Düsseldorf

Düsseldorf, Germany

Recruiting

Martini-klinik am UKE

Hamburg, Germany

Recruiting

and 3 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.