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

March 8, 2025 updated by: Francesco Sanguedolce, Fundacio Puigvert

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

  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

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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium
        • Not yet recruiting
        • Universitair Ziekenhuis Leuven
        • Contact:
        • Principal Investigator:
          • Joniau
  • France
      • Lille, France
        • Not yet recruiting
        • Hospital Center University De Lille
        • Contact:
          • Arnauld Villers, MD, Prof
      • Lyon, France
        • Not yet recruiting
        • Hospices Civils de Lyon
        • Contact:
          • Alain Ruffion, MD, Prof
        • Contact:
          • Olivier Rouvière, MD, Prof
      • Paris, France
        • Not yet recruiting
        • University Hospitals Pitié Salpêtrière
        • Contact:
          • Morgan Rouprêt, MD, Prof
  • Germany
      • Bonn, Germany
        • Not yet recruiting
        • Bonn University Hospital
        • Contact:
          • Manuel Ritter, MD, Prof
      • Hamburg, Germany
        • Not yet recruiting
        • Martini Klinik
        • Contact:
          • Lars Budaeus, MD, Prof
      • Munich, Germany
        • Not yet recruiting
        • München LMU L MU-University Clinic
        • Contact:
          • Jozsefina Casuscelli, MD, Prof
        • Contact:
          • Alexander Buchner, MD, Prof
      • Planegg, Germany
        • Not yet recruiting
        • Urologische Klinik München - Planegg
        • Contact:
          • Martin Kriegmair, MD, Prof
      • Tübingen, Germany
        • Not yet recruiting
        • Universitätsklinik Tübingen
        • Contact:
          • Steffen Rausch, MD
        • Contact:
          • Igor Tsaur, MD, Prof
        • Sub-Investigator:
          • Eva Erne, MD
  • Italy
      • Bologna, Italy
        • Not yet recruiting
        • IRCCS Universit of Bologna
        • Contact:
          • Lorenzo Bianchi, MD, Prof
        • Contact:
          • Riccardo Schiav, MD, Prof
        • Principal Investigator:
          • Stefano Fanti, MD, Prof
      • Firenze, Italy
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria Careggi
        • Contact:
          • Sergio Serni, MD, Prof
        • Contact:
          • Riccardo Campi, MD
      • Firenze, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria Careggi
        • Contact:
          • Andrea Minervini, MD, Prof
        • Sub-Investigator:
          • Fabrizio di Maida, MD
      • Milano, Italy
        • Not yet recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:
          • Alberto Briganti, MD, Prof
  • Netherlands
      • Rotterdam, Netherlands
        • Not yet recruiting
        • ERASMUS MC & Franciscus Hospital
        • Contact:
          • Rodrick van der Bergh, MD, Prof
        • Contact:
          • Robert van Soest, MD, Prof
  • Poland
      • Krakow, Poland
        • Not yet recruiting
        • Uniwersytet Jagielloński Collegium Medicum
        • Contact:
          • Piotr Chlosta, MD, Prof
        • Contact:
          • Katarzyna Gronostaj, MD
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital de La Santa Creu I Sant Pau
        • Contact:
          • Gemma Sancho, MD
      • Barcelona, Spain
      • Cordoba, Spain
        • Not yet recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
          • Enrique Gomez, MD
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Estefania Linares, MD
        • Contact:
          • Mario Álvarez, MD
        • Sub-Investigator:
          • Beatriz Debén, MD
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
          • Javier Burgos Revilla, MD
        • Contact:
          • Rodriguez Patron, MD
        • Sub-Investigator:
          • Silvia Gar, MD
      • San Cristóbal de La Laguna, Spain
        • Recruiting
        • Hospital Universitario de Canarias
        • Contact:
          • Ana Plata, MD
          • Phone Number: +34 932195154
        • Principal Investigator:
          • Ana Plata, MD
      • Santander, Spain
        • Not yet recruiting
        • Hospital Universitario Marques de Valdecilla
        • Contact:
          • Mario Dominguez, MD
      • Santiago de Compostela, Spain
        • Not yet recruiting
        • Hospital Clinico Universitario de Santiago
        • Contact:
          • Danie Perez, MD
  • Sweden
      • Malmö, Sweden
        • Not yet recruiting
        • Skånes Universitetssjukhus Malmö
        • Contact:
          • Anders Bjartell, MD, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Diagnostic test: Imaging
Imaging will be done according to local protocols and/or guidelines of EAU
Other Names:
  • CT
  • Choline PET/CT
  • PSMA PET/CT
  • whole-body MRI
  • 18F-fluciclovine PET/CT
  • Bone Scan
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)
Diagnostic test: Imaging
Imaging will be done according to local protocols and/or guidelines of EAU
Other Names:
  • CT
  • Choline PET/CT
  • PSMA PET/CT
  • whole-body MRI
  • 18F-fluciclovine PET/CT
  • 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
Diagnostic test: Imaging
Imaging will be done according to local protocols and/or guidelines of EAU
Other Names:
  • CT
  • Choline PET/CT
  • PSMA PET/CT
  • whole-body MRI
  • 18F-fluciclovine PET/CT
  • Bone Scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 - 6 weeks
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
4-6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical variables associated to NGI or conventional imaging
Time Frame: 4-6 weeks
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.
4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio Puigvert

Collaborators

Johnson & Johnson
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
European Association of Urology Research Foundation
GUARD Consortium (Genitourinary Alliance for Research and Development)
European Association of Urology - Section of Urological Imaging

Investigators

  • Study Chair: Francesco Sanguedolce, MD, PhD, Fundacio Puigvert

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2024

Primary Completion (Estimated)

December 23, 2025

Study Completion (Estimated)

December 23, 2026

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 8, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 56021927PCR4037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

GDPR regulations

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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