Clinical trial NCT06866782: European Registry of Next Generation Imaging in Advanced Prostate Cancer
Official title: European Registry of Next Generation Imaging in Advanced Prostate Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Advanced Prostate Cancer
Metastatic Prostate Cancer (mPC)
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
Lead sponsor: Fundacio Puigvert
Sponsor class: OTHER
Collaborators: name: European Association of Urology Research Foundation
name: GUARD Consortium (Genitourinary Alliance for Research and Development)
name: European Association of Urology - Section of Urological Imaging
name: Johnson & Johnson
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
First posted: 2025-03-10
Enrollment: 600
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients requiring NGI, conventional imaging, or a combination of both imaging tools.
timeFrame: 4 - 6 weeks
measure: Proportion of patients with a change of treatment determined by the imaging test result, when multiple imaging tests have been realized
timeFrame: 4-6 weeks
Secondary outcomes:
Other outcomes:
measure: Clinical variables associated to NGI or conventional imaging
timeFrame: 4-6 weeks
Locations:
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Lille
country: France
facility: Hospital Center University De Lille
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Paris
country: France
facility: University Hospitals Pitié Salpêtrière
city: Bonn
country: Germany
facility: Bonn University Hospital
city: Hamburg
country: Germany
facility: Martini Klinik
city: Munich
country: Germany
facility: München LMU L MU-University Clinic
city: Planegg
country: Germany
facility: Urologische Klinik München - Planegg
city: Tübingen
country: Germany
facility: Universitätsklinik Tübingen
city: Bologna
country: Italy
facility: IRCCS Universit of Bologna
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Rotterdam
country: Netherlands
facility: ERASMUS MC & Franciscus Hospital
city: Krakow
country: Poland
facility: Uniwersytet Jagielloński Collegium Medicum
city: Barcelona
country: Spain
facility: Fundació Puigvert
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: San Cristóbal de La Laguna
country: Spain
facility: Hospital Universitario de Canarias
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago
city: Malmö
country: Sweden
facility: Skånes universitetssjukhus Malmö
Study officials:
affiliation: Fundació Puigvert
name: Francesco Sanguedolce, MD, PhD
role: STUDY_CHAIR
References: