High-resolution Intra-operative PSMA PET-CT in Prostate Cancer

Launched by IRCCS SAN RAFFAELE · Mar 1, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new imaging technique called high-resolution PET-CT scan to help doctors better determine if prostate cancer has spread to nearby lymph nodes during surgery. The trial involves 10 men who have been diagnosed with prostate cancer and have a higher risk of lymph node invasion. These men will be undergoing a specific type of surgery called robot-assisted radical prostatectomy, along with extended pelvic lymph node dissection, which is a procedure to remove lymph nodes in the pelvic area.

To be eligible for this study, participants must be men aged 18 or older with confirmed high-risk prostate cancer who are planned for the surgery mentioned. They need to be able to understand and agree to participate in the trial. Unfortunately, those with certain health issues, such as infections or previous radiation treatment for prostate cancer, cannot join. Participants will receive the PET-CT scan during their surgery to see how well this new method works in assessing cancer spread. The results will help researchers understand if this imaging technique can improve safety and outcomes for patients undergoing prostate cancer surgery.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Male patient, 18 years of age or older.
• • 2. Patient is confirmed with high risk prostate cancer.
• • 3. Patient is indicated to undergo radical prostatectomy and ePLND.
• • 4. Patient is estimated compliant for study participation by the investigator.
• • 5. Patient has freely given his/her informed consent to participate in this study.
• Exclusion Criteria:
• • 1. Patient has general or local contra-indications for radical prostatectomy.
• • 2. Patient has active viral or fungal infection.
• • 3. Patient previously received radiotherapy of the prostate.
• • 4. Patient participated in other clinical studies with radiation exposure of more than 1 mSv in the past year.