Comparing imaging methods for prostate cancer treatment evaluation
Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer (mCRPC) to the Bone: A Whole Body MRI Study
This study is testing whether whole body MRI is better than bone scans and CT scans for checking how well treatments are working in men with advanced prostate cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | denosumab, chemotherapy |
| Locations | 1 site (Milan) |
| Trial ID | NCT06321679 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the effectiveness of whole body magnetic resonance imaging (WB-MRI) with bone scintigraphy (BS) and computerized tomography (CT) scans in patients with metastatic castration-resistant prostate cancer. Patients will receive various treatment regimens at the discretion of their clinicians, and imaging assessments will be conducted at baseline and every 12 weeks thereafter for up to 192 weeks. The study will also include patient questionnaires to evaluate their perceptions and preferences regarding the imaging modalities used.
Who should consider this trial
Good fit: Ideal candidates include patients with a histological diagnosis of castration-resistant prostate cancer and single or multiple bone metastases.
Not a fit: Patients with absolute contraindications to WB-MRI, CT, or BS, or those who have undergone radical treatment for metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective imaging techniques for monitoring treatment response in prostate cancer patients.
How similar studies have performed: Other studies have shown promising results in using advanced imaging techniques for cancer evaluation, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Milan
- IEO Istituto Europeo di Oncologia — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Giuseppe Petralia — European Institute of Oncology
- Study coordinator: Giuseppe Petralia, MD
- Email: giuseppe.petralia@ieo.it
- Phone: +39 02 9437 2901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.