Prostate CancerRINGNCT06866782
European Registry of Next Generation Imaging in Advanced Prostate Cancer
An observational study of Prostate Cancer and Advanced Prostate Cancer, run by Fundacio Puigvert at 24 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Advanced Prostate Cancer, Metastatic Prostate Cancer (mPC)
- What is being tested?
- Imaging
- How many people
- 600 participants
- Where
- 24 sitesin 8 countries
- Study dates
- 17 Sep 2024to 23 Dec 2026
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
24 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
24 sites in 8 countries
Spain8 sites, 8 recruiting
- Recruiting
Fundació Puigvert
Barcelona
Francesco Sanguedolce, MD, PhD, +34934169700, fsanguedol@fundacio-puigvert.es
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
Gemma Sancho, MD
- Not yet recruiting
Hospital Universitario Reina Sofia
Córdoba
Enrique Gómez, MD
- Not yet recruiting
Hospital Universitario La Paz
Madrid
Estefania Linares, MD
Mario Álvarez, MD
- Not yet recruiting
Hospital Universitario Ramón y Cajal
Madrid
Javier Burgos Revilla, MD
Rodriguez Patron, MD
- Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna
Ana Plata, MD, +34 932195154
Ana Plata, MD
- Not yet recruiting
Hospital Universitario Marqués de Valdecilla
Santander
Mario Dominguez, MD
- Not yet recruiting
Hospital Clínico Universitario de Santiago
Santiago de Compostela
Danie Perez, MD
Germany5 sites, 5 recruiting
- Not yet recruiting
Bonn University Hospital
Bonn
Manuel Ritter, MD, Prof
- Not yet recruiting
Martini Klinik
Hamburg
Lars Budaeus, MD, Prof
- Not yet recruiting
München LMU L MU-University Clinic
Munich
Jozsefina Casuscelli, MD, Prof
Alexander Buchner, MD, Prof
- Not yet recruiting
Urologische Klinik München - Planegg
Planegg
Martin Kriegmair, MD, Prof
- Not yet recruiting
Universitätsklinik Tübingen
Tübingen
Steffen Rausch, MD
Igor Tsaur, MD, Prof
Italy4 sites, 4 recruiting
- Not yet recruiting
IRCCS Universit of Bologna
Bologna
Lorenzo Bianchi, MD, Prof
Riccardo Schiav, MD, Prof
- Recruiting
Azienda Ospedaliero-Universitaria Careggi
Florence
Andrea Minervini, MD, Prof
Fabrizio di Maida, MD
- Not yet recruiting
Azienda Ospedaliero-Universitaria Careggi
Florence
Sergio Serni, MD, Prof
Riccardo Campi, MD
- Not yet recruiting
IRCCS Ospedale San Raffaele
Milan
Alberto Briganti, MD, Prof
France3 sites, 3 recruiting
- Not yet recruiting
Hospital Center University De Lille
Lille
Arnauld Villers, MD, Prof
- Not yet recruiting
Hospices Civils de Lyon
Lyon
Alain Ruffion, MD, Prof
Olivier Rouvière, MD, Prof
- Not yet recruiting
University Hospitals Pitié Salpêtrière
Paris
Morgan Rouprêt, MD, Prof
Belgium1 site, 1 recruiting
- Not yet recruiting
Universitair Ziekenhuis Leuven
Leuven
Steven Joniau, MD, Prof, steven.joniau@uzleuven.be
Joniau
Netherlands1 site, 1 recruiting
- Not yet recruiting
ERASMUS MC & Franciscus Hospital
Rotterdam
Rodrick van der Bergh, MD, Prof
Robert van Soest, MD, Prof
Poland1 site, 1 recruiting
- Not yet recruiting
Uniwersytet Jagielloński Collegium Medicum
Krakow
Piotr Chlosta, MD, Prof
Katarzyna Gronostaj, MD
Sweden1 site, 1 recruiting
- Not yet recruiting
Skånes universitetssjukhus Malmö
Malmö
Anders Bjartell, MD, Prof
About this study
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.
Read the 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
- To identify the proportion of patients for whom an imaging work-up with NGI at baseline may result beneficial, according to physician criteria.
- Assess management prompted by NGI vs. conventional imaging in usual clinical practice.
- To identify the proportion of patients for whom conventional imaging is considered informative enough for making a clinical decision, according to physician criteria.
- Stratification of metastatic prostate cancer patients by the number, volume, and location of deposits, according to the different imaging tools employed.
- 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
- 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.
- Being tested
- Imaging
- Keywords
- prostate cancer, advanced prostate cancer, new generation imaging, conventional imaging, Metastatic Prostate Cancer, Magnetic Resonance Imaging, PET/CT PSMA, Prostate-Specific Membrane Antigen, Imaging Biomarkers, bone scan, CT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingDiagnostic test
Also called whole-body MRI, PSMA PET/CT, 18F-fluciclovine PET/CT, Bone Scan
Imaging will be done according to local protocols and/or guidelines of EAU
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Imaging | |
| 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) Receives: Diagnostic Test: Imaging | |
| 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 Receives: Diagnostic Test: Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start17 Sep 2024
- Primary completion23 Dec 2025 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Fundacio Puigvert
- Sponsor type
- University, hospital or other
- Collaborators
- European Association of Urology Research Foundation, Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD, European Association of Urology - Section of Urological Imaging, Johnson & Johnson, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Responsible party
- Principal investigator, Francesco Sanguedolce, Fundacio Puigvert
- Investigators
- Francesco Sanguedolce, MD, PhD, Study chair, Fundació Puigvert
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866782
- Sponsor's protocol ID
- 56021927PCR4037
- Acronym
- RING
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: GDPR regulations
Publications
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.
PubMed 41338644
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Registry of Next Generation Imaging in Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT06866782
- Acronym / sponsor ID
- RING / 56021927PCR4037
- Keywords
- prostate cancer, advanced prostate cancer, new generation imaging, conventional imaging, Metastatic Prostate Cancer, Magnetic Resonance Imaging, PET/CT PSMA, Prostate-Specific Membrane Antigen
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fundacio PuigvertUniversity, hospital or other
- Collaborators
- European Association of Urology Research Foundation, Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD, European Association of Urology - Section of Urological Imaging, Johnson & Johnson, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 23 Dec 2025 (estimated)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To identify the proportion of patients for whom an imaging work-up with NGI at baseline may result beneficial, according to physician criteria.
- Assess management prompted by NGI vs. conventional imaging in usual clinical practice.
- To identify the proportion of patients for whom conventional imaging is considered informative enough for making a clinical decision, according to physician criteria.
- Stratification of metastatic prostate cancer patients by the number, volume, and location of deposits, according to the different imaging tools employed.
- 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
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| New generation imaging | – | Diagnostic Test: ImagingPatients 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 | – | Diagnostic Test: ImagingPatients 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 | – | Diagnostic Test: ImagingPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImagingAlso: whole-body MRI, PSMA PET/CT, 18F-fluciclovine PET/CT, Bone ScanImaging will be done according to local protocols and/or guidelines of EAU | Diagnostic test | Conventional imaging, Conventional imaging and New generation imaging, New generation imaging |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Derived from this study: PubMed 41338644Chernysheva 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.
- Individual participant dataSharing planned: No. GDPR regulations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesco Sanguedolce, MD, PhD study chair
Fundació Puigvert
24 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Advanced Prostate Cancer, run by Fundacio Puigvert at 24 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Spain, Germany, Italy, France, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Sanguedolce, MD, PhD (+34934169100 ext. 4509, fsanguedol@fundacio-puigvert.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients requiring NGI, conventional imaging, or a combination of both imaging tools. (time frame: 4 - 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06866782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.