64Cu-SAR-bisPSMA PET/CT for Prostate Cancer
(AMPLIFY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new imaging method called 64Cu-SAR-bisPSMA PET/CT to evaluate its effectiveness in detecting returning prostate cancer. The goal is to enhance the detection of cancer recurrence after initial treatment. This trial suits individuals who have undergone prostate cancer treatment, such as surgery or radiation, and now experience rising PSA levels, a protein in the blood that may indicate cancer presence. Participants should be willing to undergo additional tests, like a biopsy, if necessary. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking advancement in cancer detection.
Will I have to stop taking my current medications?
The trial requires that you stop any ongoing treatment or treatment within 6 months with systemic therapies for prostate cancer, such as hormone therapies or chemotherapy. If you're on these medications, you may need to stop them to participate.
What prior data suggests that 64Cu-SAR-bisPSMA PET/CT is safe for detecting prostate cancer recurrence?
Research has shown that 64Cu-SAR-bisPSMA is safe for humans. Studies have found that this treatment effectively identifies prostate cancer spots in patients and is well-tolerated, with no serious side effects reported. The FDA granted it a Fast Track Designation, highlighting its potential value and safety. Currently, this treatment is in a phase 3 trial, indicating it has already passed earlier safety tests.12345
Why are researchers excited about this trial?
64Cu-SAR-bisPSMA is unique because it uses a novel radioactive tracer, copper-64, to target prostate-specific membrane antigen (PSMA) in prostate cancer cells. Most current treatments for prostate cancer involve hormonal therapies or chemotherapy, which work by slowing the growth of cancer cells or killing them directly. However, 64Cu-SAR-bisPSMA offers a different approach by highlighting cancer cells in PET/CT scans, potentially improving diagnostic accuracy and helping to tailor more effective treatment plans. Researchers are excited about this because it could lead to earlier detection and more personalized treatment strategies, improving outcomes for patients with prostate cancer.
What evidence suggests that 64Cu-SAR-bisPSMA PET/CT is effective for detecting prostate cancer recurrence?
Research has shown that 64Cu-SAR-bisPSMA, the investigational imaging agent studied in this trial, effectively identifies recurrent prostate cancer. It detects cancer cells 2 to 3 times better than some other methods. One study found cancer in up to 80% of participants who previously received negative results with standard imaging tests. This imaging agent also identifies more prostate cancer spots compared to the commonly used 68Ga-PSMA-11 PET/CT, particularly in patients with low PSA levels, which indicate prostate cancer activity. These findings support the use of 64Cu-SAR-bisPSMA for improved detection and understanding of prostate cancer.56789
Are You a Good Fit for This Trial?
This trial is for men who've had prostate cancer treatment but now have signs it might be coming back. They need a rising PSA level after surgery or radiation, cryotherapy, or brachytherapy. They should be healthy enough to live at least another 6 months and able to potentially undergo more treatment if needed.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Imaging
Participants undergo 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
Follow-up
Participants are monitored for safety and effectiveness after imaging
What Are the Treatments Tested in This Trial?
Interventions
- 64Cu-SAR-bisPSMA
Find a Clinic Near You
Who Is Running the Clinical Trial?
Clarity Pharmaceuticals Ltd
Lead Sponsor