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| Name | Class |
|---|---|
| European Association of Urology Research Foundation | OTHER |
| Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD | OTHER |
| European Association of Urology - Section of Urological Imaging |
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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.
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. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New generation imaging | 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) |
| |
| Conventional imaging | 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) |
| |
| Conventional imaging and New generation imaging | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imaging | Diagnostic Test | Imaging will be done according to local protocols and/or guidelines of EAU |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 - 6 weeks |
| 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 | 4-6 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Sanguedolce, MD, PhD | Contact | +34934169100 | 4509 | fsanguedol@fundacio-puigvert.es |
| Daria Chernysheva, MD, PhD | Contact | +34672034192 | daria.chern@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Sanguedolce, MD, PhD | Fundació Puigvert | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Leuven | Not yet recruiting | Leuven | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41338644 | Derived | Chernysheva D, Fanti S, Bjartell A, Afferi L, Breda A, Palou J, Padhani AR, Sanguedolce F. European Registry of Next Generation Imaging in Advanced Prostate Cancer (RING): protocol for an international, prospective registry study. BMJ Open. 2025 Dec 3;15(12):e106022. doi: 10.1136/bmjopen-2025-106022. |
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GDPR regulations
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2024 |
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| Johnson & Johnson | INDUSTRY |
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | OTHER |
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|
| 4-6 weeks |
| Hospital Center University De Lille | Not yet recruiting | Lille | France |
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| Hospices Civils de Lyon | Not yet recruiting | Lyon | France |
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| University Hospitals Pitié Salpêtrière | Not yet recruiting | Paris | France |
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| Bonn University Hospital | Not yet recruiting | Bonn | Germany |
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| Martini Klinik | Not yet recruiting | Hamburg | Germany |
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| München LMU L MU-University Clinic | Not yet recruiting | Munich | Germany |
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| Urologische Klinik München - Planegg | Not yet recruiting | Planegg | Germany |
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| Universitätsklinik Tübingen | Not yet recruiting | Tübingen | Germany |
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| IRCCS Universit of Bologna | Not yet recruiting | Bologna | Italy |
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| Azienda Ospedaliero-Universitaria Careggi | Recruiting | Florence | Italy |
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| Azienda Ospedaliero-Universitaria Careggi | Not yet recruiting | Florence | Italy |
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| IRCCS Ospedale San Raffaele | Not yet recruiting | Milan | Italy |
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| ERASMUS MC & Franciscus Hospital | Not yet recruiting | Rotterdam | Netherlands |
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| Uniwersytet Jagielloński Collegium Medicum | Not yet recruiting | Krakow | Poland |
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| Fundació Puigvert | Recruiting | Barcelona | Spain |
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| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Spain |
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| Hospital Universitario Reina Sofia | Not yet recruiting | Córdoba | Spain |
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| Hospital Universitario La Paz | Not yet recruiting | Madrid | Spain |
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| Hospital Universitario Ramón y Cajal | Not yet recruiting | Madrid | Spain |
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| Hospital Universitario de Canarias | Recruiting | San Cristóbal de La Laguna | Spain |
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| Hospital Universitario Marqués de Valdecilla | Not yet recruiting | Santander | Spain |
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| Hospital Clínico Universitario de Santiago | Not yet recruiting | Santiago de Compostela | Spain |
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| Skånes universitetssjukhus Malmö | Not yet recruiting | Malmö | Sweden |
|
| Feb 24, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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