European Registry of Next Generation Imaging in Advanced Prostate Cancer (RING)

Puigvert Foundation

Status: Enrolling

Conditions: Metastatic Prostate Cancer (mPC); Advanced Prostate Cancer; Prostate Cancer

Treatments: Diagnostic Test: Imaging

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06866782

56021927PCR4037

Details and patient eligibility

About

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.

Full 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

1. To identify the proportion of patients for whom an imaging work-up with NGI at baseline may result beneficial, according to physician criteria.

2. Assess management prompted by NGI vs. conventional imaging in usual clinical practice.

3. To identify the proportion of patients for whom conventional imaging is considered informative enough for making a clinical decision, according to physician criteria.

4. Stratification of metastatic prostate cancer patients by the number, volume, and location of deposits, according to the different imaging tools employed.

5. 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

6. 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.

Enrollment: 600 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult male patients (≥18 years with no upper age limit).
2. Histologically proven prostate cancer.
3. 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.
4. Patients who authorize their participation in the study by signing a written informed consent form (ICF).

Exclusion criteria

1. Patients participating in other interventional or non-interventional study which requires NGI as a triage test for metastatic assessment.
2. Patients with evidence of any other clinically significant disease or condition which in the opinion of the investigator discourages their participation in the study.
3. Patients who will not be able to complete the study.

Trial design

600 participants in 3 patient groups

New generation imaging

Description:

Patients with prostate cancer at high risk for harbouring metastatic deposits at the hormone-sensitive stage, who require imaging exploration either at the diagnostic workup of a "naïve" patient or at biochemical relapse/progression after local treatment with the use of next generation imaging ( whole-body MRI and PET/CT with new tracers (F/Ga-PSMA, 18F-fluciclovine)

Treatment:

Diagnostic Test: Imaging

Conventional imaging

Description:

Patients with prostate cancer at high risk for harbouring metastatic deposits at the hormone-sensitive stage, who require imaging exploration either at the diagnostic workup of a "naïve" patient or at biochemical relapse/progression after local treatment with the use of conventional imaging ( CT and bone scan)

Treatment:

Diagnostic Test: Imaging

Conventional imaging and New generation imaging

Description:

Patients with prostate cancer at high risk for harbouring metastatic deposits at the hormone-sensitive stage, who require imaging exploration either at the diagnostic workup of a "naïve" patient or at biochemical relapse/progression after local treatment with the use of conventional imaging ( CT and bone scan) AND next generation imaging

Treatment:

Diagnostic Test: Imaging