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European Registry of Next Generation Imaging in Advanced Prostate Cancer

ConditionsProstate CancerAdvanced Prostate CancerMetastatic Prostate Cancer (mPC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorFundacio Puigvert

About this trial

The RING study is a European registry collecting real-world data on advanced prostate cancer (APC) imaging. It aims to evaluate the role of next-generation imaging (NGI), such as PET/CT and whole-body MRI, in detecting and monitoring the disease compared to conventional imaging.

Men aged 18 or older with histologically confirmed prostate cancer are eligible to participate in the study if they require imaging to assess potential metastases, either at diagnosis or after relapse and sign a consent form.

Patients will receive standard care with no experimental treatments. Imaging and treatment decisions will follow routine clinical practice. Data will be collected from medical records and analysed for research. This study will help doctors understand when NGI should be used, how it affects treatment decisions, and its impact on patient outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult male patients (≥18 years with no upper age limit).

Histologically proven prostate cancer.

Patients who require imaging exploration (conventional, Next-Generation Imaging (NGI), or their combination) at high risk for harbouring metastatic deposits at the hormone-sensitive stage, either at the diagnostic workout of a "naïve" patient or at biochemical relapse/progression after local treatment.

Patients who authorize their participation in the study by signing a written informed consent form (ICF).

Disqualifiers

Patients participating in other interventional or non-interventional study which requires NGI as a triage test for metastatic assessment.

Patients with evidence of any other clinically significant disease or condition which in the opinion of the investigator discourages their participation in the study.

Patients who will not be able to complete the study.

Trial population

Outpatient "naive" or relapsed/progressed patients above 18 years with prostate cancer at high risk for harbouring metastatic deposits at the hormone-sensitive stage, who require imaging exploration (conventional, NGI, or their combination)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Imaging

    Diagnostic test

    Imaging will be done according to local protocols and/or guidelines of EAU

Treatment groups

600 Participants
are divided into 3 treatment groups
Group A: New generation imaging1 intervention
Group B: Conventional imaging1 intervention
Group C: Conventional imaging and New generation imaging1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients requiring NGI, conventional imaging, or a combination of both imaging tools.

Number of patients who require NGI, conventional imaging, or a combination of both imaging tools with the respect to local protocols

Time frame
4 - 6 weeks
2

Proportion of patients with a change of treatment determined by the imaging test result, when multiple imaging tests have been realized

Number of patients who received multiple imaging tests for whom the result of the particular imaging test has lead to the change in management

Time frame
4-6 weeks

Secondary outcomes

Other outcomes

1

Clinical variables associated to NGI or conventional imaging

The investigators aim to identify which clinical characteristics (age, ethnicity, comorbidities, PSA, PSA doubling time, ISUP grade at biopsy or at specimens, etc), are associated to the clinical decision of undertaking a systemic work-up with either NGI or CI. This outcome will be measured by means of a univariate and multivariate statistical analysis.

Time frame
4-6 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundacio Puigvert

Lead sponsor

European Association of Urology Research Foundation

Collaborator

GUARD Consortium (Genitourinary Alliance for Research and Development)

Collaborator

European Association of Urology - Section of Urological Imaging

Collaborator

Johnson & Johnson

Collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Collaborator

Source ClinicalTrials.gov
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