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PRISMA-PET - Primary Staging of Prostate Cancer With PSMA

NCT05123300 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2025-02-03

No results posted yet for this study

Summary

Early and correct diagnostic staging is paramount to keep patients with newly diagnosed prostate cancer in the correct treatment tract to avoid under- and overdiagnosis in prostate cancer staging. With accurate staging, the investigators aim to save patients from side effects of insufficient or too extensive treatment. The investigators hypothesize that precise staging will lead to optimized individualized treatment and subsequently to prolonged survival and increased quality of life.

Prostate cancer is a very heterogeneous disease varying from indolent tumors to aggressive cancer types. About one-fifth of patients with newly detected high- or intermediate-risk prostate cancer present with bone metastases and their 3-years survival is less than 50%. Precise staging is required for planning relevant treatment that has the potential to increase survival.

The prostate-specific membrane antigen (PSMA) is overexpressed in prostate cancer cells and can serve as a target for precise diagnosis and staging. PSMA-positron emission tomography/computed tomography (PET/CT) has shown to be more accurate than traditional imaging, but there is a need for prospective trials analyzing the impact of primary staging with PSMA-PET/CT on treatment planning and patient benefit.

In a prospective multicenter study, the investigators plan to include 448 patients and randomize 1:1 to either traditional imaging or PSMA-PET/CT. The investigators aim to analyze whether PSMA-PET/CT increases progression-free survival and quality of life. Further, the investigators aim to validate the accuracy of primary staging with PSMA-PET/CT compared with conventional imaging.

Conditions

Interventions

DIAGNOSTIC_TEST

18F-PSMA-1007

18F-PSMA-1007 is a tracer for a PET/CT. Prostate cancer often has marked uptake of PSMA, hence PSMA-PET/CT is in the guidelines in the European Union for detecting relapse. But we will use it for staging primary prostate cancer.

Sponsors & Collaborators

  • Sygehus Lillebaelt

    collaborator OTHER

  • Esbjerg Hospital - University Hospital of Southern Denmark

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-04
Primary Completion
2025-01-21
Completion
2025-01-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05123300 on ClinicalTrials.gov