Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer to the Bone

NCT06321679 | Recruiting

• 1 other identifier: IEO 1269
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aimed to compare whole body MRI (WB-MRI) with Bone Scintigraphy (BS) and Computerized Tomography (CT) scans in patients receiving treatment for metastatic castration-resistant prostate cancer to the bone. This is a monocentric, prospective observational study.

Conditions

Castration-resistant Prostate Cancer

Keywords

castration-resistant prostate cancer; whole body magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Time to disease progression in bone metastasis identify by WB-MRI

  the proportion of WB-MRI examinations that identify disease progression in bone metastases prior to CT + BS

  192 weeks

Study Arms (1)

WB-MRI

Each patient will undergo imaging with CT, BS and WB-MRI at each study timepoint

Procedure: Imaging evaluation

Interventions

Imaging evaluation PROCEDURE

each patient will undergo imaging with CT, BS and WB-MRI at each study timepoint

WB-MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The estimated rate of recruitment to the study 6-7 patients a month, thus it is expected that patient accrual will be completed within 7 months. Based on recent treatment patterns, the expected distribution of treatments is: * Hormonal treatments * Enzalutamide: 14 patients * Abiraterone: 8 patients * Chemotherapy * Docetaxel: 11 patients * Cabazitaxel: 5 patients * Radiopharmaceutical drug - Radium-223: 2 patients

You may qualify if:

• Histological diagnosis of castration-resistant prostate cancer,
• Single or multiple bone metastases,
• Life expectancy of over 6 months,
• No current active malignancy other than prostate cancer,
• Provision of written informed consent.

You may not qualify if:

• Absolute contraindication to WB-MRI, CT or BS,
• Radical treatment of sole site of metastatic disease (e.g. Cyberknife to solitary metastatic lesion),
• Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions are to be discussed with the patient as part of the informed consent process.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

IEO Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

Study Officials

• Giuseppe Petralia

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Petralia, MD

CONTACT

+39 02 9437 2901; giuseppe.petralia@ieo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: July 3, 2020
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

IT (1)