Testing a new imaging method for assessing prostate cancer aggressiveness

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.

This study is testing a new imaging method to see if it can help doctors better understand how aggressive untreated prostate cancer is in men who are closely monitoring their condition.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Curasight (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 4 sites (Aalborg and 3 other locations)
• Trial ID: NCT06474806 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and diagnostic performance of a novel PET imaging agent, 64Cu-DOTA-AE105, in patients with localized, untreated prostate cancer. The study will assess whether this imaging technique can accurately determine the aggressiveness of prostate cancer, potentially serving as an alternative or supplement to traditional biopsies. Participants will receive two injections of the experimental agent, which binds to specific cancer cells, allowing visualization through PET scanning. The trial focuses on patients with low-risk prostate cancer who are under active surveillance.

Who should consider this trial

Good fit: Ideal candidates are men diagnosed with untreated, low-grade localized prostate cancer (ISUP grade 1 to 3) who are eligible for active surveillance.

Not a fit: Patients who have received prior treatment for prostate cancer or have a higher ISUP grade may not benefit from this study.

Why it matters

Potential benefit: If successful, this imaging method could reduce the need for invasive biopsies in monitoring prostate cancer.

How similar studies have performed: While this approach is innovative, similar imaging techniques have shown promise in other studies, suggesting potential for success.

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:

Where this trial is running

Aalborg and 3 other locations

• Aalborg University Hospital — Aalborg, Denmark (Recruiting)
• Vejle Hospital — Vejle, Denmark (Recruiting)
• Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
• Skåne University Hospital — Skåne, Sweden (Recruiting)

Study contacts

• Study coordinator: Project Manager

Conditions Prostate Cancer