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

Launched by CURASIGHT · Jun 19, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new imaging technique called uPAR PET imaging to see how well it can determine the aggressiveness of untreated prostate cancer. The goal is to find out if this imaging test can be a helpful alternative or addition to traditional biopsies for patients with low-risk prostate cancer who are being monitored closely. The test involves an injection of a special agent that helps doctors visualize the cancer in the prostate using a PET scanner.

To participate in this trial, you need to be a man aged 65 to 74, diagnosed with low-grade, localized prostate cancer that has not been treated before. You must have had a recent biopsy confirming your diagnosis, and you should be in generally good health. During the trial, you will receive one or two injections of the imaging agent on separate days, followed by scans to capture images of your prostate. Before and after the injections, some health tests will be performed to ensure your well-being. Overall, this trial aims to improve how doctors assess prostate cancer without relying solely on biopsies.

Gender

MALE

Eligibility criteria

• 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: