Accurate Prostate Cancer Following Using Low-Field MRI (Low-PRISM)

Launched by UNIVERSITY OF LAUSANNE HOSPITALS · Jun 25, 2024

Keywords

ClinConnect Summary

The Low-PRISM trial is a study that investigates how well low-field MRI machines (which use a lower strength magnet) work compared to high-field MRI machines (which use a stronger magnet) for detecting prostate cancer. The study is divided into three parts: first, it aims to improve the low-field MRI imaging process using healthy volunteers; second, it will assess how well low-field MRI works for men who have metal implants, like hip replacements, that might interfere with imaging; and finally, it will test the low-field MRI on men who have suspicious findings from high-field MRIs that may need further investigation.

To be eligible for this trial, participants must be adult men aged 18 or older. For the first part, healthy volunteers are welcome, while the second part focuses on men with metal implants, and the third part includes men who have concerning signs of prostate cancer detected through a high-field MRI. Participants will need to provide consent to be part of the study and agree to be informed about any unexpected findings during their MRI. This trial is currently recruiting participants and aims to improve prostate cancer screening methods, which could ultimately help in early detection and treatment.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Work Package1 (WP): 0.55T MRI Protocol Development
• • Healthy male volunteers aged 18 and above.
• • Agree to be contacted for incidental findings
• • Signed informed consent
• • WP2: 0.55T Prostate MRI with patients with metallic implant(s)
• • Adult men (≥18 y.o) with 3T MRI reported as sub-diagnostic due to metallic implants
• • Signed informed Consent
• • WP3: 0.55T Prostate MRI with patients with suspicious lesion(s)
• • Adult men (≥18 y.o)
• • PI-RADS 4/5 lesions detected on 3T MRI, schedules for targeted biopsy
• • Signed informed consent
• Exclusion Criteria:
• • WP1: 0.55T MRI Protocol Development
• • Individuals with a history of prostate cancer
• • MR Contraindications as listed in the MR Safety Screening form
• • WP2: 0.55T Prostate MRI with patients with metallic implant(s)
• • Contraindications as per MD instructions
• • Any condition making the patient unsuitable for the study
• • Refusal to be notified in case of incidental finding on the examination
• • WP3: 0.55T Prostate MRI with patients with suspicious lesion(s)
• • Individuals with a history of prostate cancer.
• • Contraindications as per MD instructions
• • Any condition making the patient unsuitable for the study
• • Refusal to be notified in case of incidental finding on the examination