Actively Recruiting
Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer to the Bone Using Whole Body MRI
Led by European Institute of Oncology · Updated on 2024-03-20
40
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing whole body MRI (WB-MRI) with Bone Scintigraphy (BS) and Computerized Tomography (CT) scans in men with metastatic castration-resistant prostate cancer that has spread to the bone. This prospective observational study aims to evaluate these imaging methods while patients receive standard treatments such as hormonal therapy, chemotherapy, radium-223, bisphosphonates, denosumab, or supportive care. The study is conducted at a single center and does not change the treatments patients receive. Patients will undergo CT, BS, and WB-MRI imaging at the start of the study and every 12 weeks up to week 96. After this, imaging will occur every 24 weeks until disease progression or week 192. Treatment choices, dosing, schedules, and monitoring are decided by the treating clinicians. Radiotherapy is allowed with communication to avoid affecting imaging interpretation. Questionnaires about imaging preferences will be collected at baseline, week 36, and study end. Participants will have routine clinical and physical examinations throughout the study. Radiologists reading the WB-MRI scans will not know the CT and BS results, and vice versa, to reduce bias. The main outcome measured is the time to disease progression in bone metastases identified by WB-MRI over 192 weeks. The total duration of participant involvement can be up to nearly four years, with ongoing imaging and assessments throughout.
CONDITIONS
Brief Title
Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer to the Bone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of castration-resistant prostate cancer
- Presence of single or multiple bone metastases
- Life expectancy greater than 6 months
- No current active malignancy other than prostate cancer
- Provision of written informed consent
You will not qualify if you...
- Absolute contraindication to whole body MRI, CT, or Bone Scintigraphy
- Radical treatment of sole site of metastatic disease (e.g., Cyberknife to solitary metastatic lesion)
- Psychological, familial, sociological, or geographical conditions preventing compliance with study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 192 weeks or until disease progression
Participants undergo imaging evaluations including CT, Bone Scintigraphy, and Whole Body MRI at scheduled intervals to monitor bone metastases. Clinical and physical examinations are also performed according to routine clinical practice.
Imaging visits every 12 weeks until week 96, then every 24 weeks until week 192 or disease progression
Trial Site Locations
Total: 1 location
1
IEO Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
Research Team
G
Giuseppe Petralia, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here