RecruitingPhase 2NCT06907641

Comparative Performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga PSMA-11 PET CT for the Detection of Prostate Cancer Recurrence in the Setting of Biochemical Failure Following Radical Prostatectomy


Sponsor

St Vincent's Hospital, Sydney

Enrollment

50 participants

Start Date

Nov 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to compare 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT in men with biochemical failure following radical prostatectomy. The main questions it aims to answer are: * Is there a difference in the number of lesions of prostate cancer recurrence detected between the 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT scans. * What is the diagnostic accuracy of 64Cu-SAR-bisPSMA PET/CT compared to 68Ga PSMA-11 PET/CT using a standard of care comparator. * Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11). Participants will: * have 3 visits: 1) standard of care 68Ga PSMA-11 dose and PET/CT scan; 2) 64Cu-SAR-bisPSMA dose and PET/CT; 3) 64Cu-SAR-bisPSMA PET/CT only * have standard of care blood test either at Visit 1 or Visit 2


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of PET scans that use different radioactive tracers — one using copper-64 and one using gallium-68 — to detect prostate cancer recurrence after the prostate has been surgically removed, to determine which scan is better at finding the cancer. **You may be eligible if...** - You are a male 18 or older - You previously had your prostate removed for prostate cancer confirmed by biopsy - Your PSA (a prostate cancer marker in the blood) is rising, specifically between 0.20 and 0.75 ng/mL - You have not yet had salvage radiation therapy - You have already had a gallium-68 PSMA PET/CT scan within the last 4 weeks **You may NOT be eligible if...** - You have already received or are not a candidate for salvage radiation therapy - You have another active cancer - You have had hormone or other systemic therapy for your prostate cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUG64Cu-SAR-bisPSMA

All participants will receive a single administration of 200 MBq of 64Cu-SAR-bisPSMA


Locations(1)

St Vincent's Hospital, Sydney

Darlinghurst, New South Wales, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06907641


Related Trials