European Registry of Next Generation Imaging in Advanced Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 600
- Locations
- 23
- Primary Endpoint
- Proportion of patients requiring NGI, conventional imaging, or a combination of both imaging tools.
Study Overview
Brief Summary
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.
Detailed Description
This registry is intended to collect real-world data on patient demographics, medical history, clinical endpoints, histological tumour characteristics and imaging explorations of the patients with prostate cancer at high risk for harbouring metastatic deposits at the hormone-sensitive stage, who require imaging exploration (conventional, NGI, or their combination) either at the diagnostic workup of a "naïve" patient or at biochemical relapse/progression after local treatment.
Stage 1: cross-sectional observation
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To identify the proportion of patients for whom an imaging work-up with NGI at baseline may result beneficial, according to physician criteria.
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Assess management prompted by NGI vs. conventional imaging in usual clinical practice.
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To identify the proportion of patients for whom conventional imaging is considered informative enough for making a clinical decision, according to physician criteria.
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Stratification of metastatic prostate cancer patients by the number, volume, and location of deposits, according to the different imaging tools employed.
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Reclassification of HSPC (M0 vs low vs. high volume) based on NGI respect to CI when both imaging modalities are used. Stage 2: longitudinal observation
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Evaluation of survival outcomes and their relationship with the imaging pathway undertaken (overall and per subgroup of imaging modality). 2. Identification of prognostic factors related to treatment response and disease progression.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Proportion of patients requiring NGI, conventional imaging, or a combination of both imaging tools.
Time Frame: 4 - 6 weeks
Number of patients who require NGI, conventional imaging, or a combination of both imaging tools with the respect to local protocols
Proportion of patients with a change of treatment determined by the imaging test result, when multiple imaging tests have been realized
Time Frame: 4-6 weeks
Number of patients who received multiple imaging tests for whom the result of the particular imaging test has lead to the change in management
Secondary Outcomes
No secondary outcomes reported
Investigators
Francesco Sanguedolce
Chief Investigator
Fundacio Puigvert