64Cu-SAR-bisPSMA PET/CT for Prostate Cancer
(AMPLIFY Trial)
CP
Overseen ByClarity Pharmaceuticals Clarity Clinical Trials Contact
Age: 18+
Sex: Male
Trial Phase: Phase 3
Sponsor: Clarity Pharmaceuticals Ltd
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
The aim for this study is to investigate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
Eligibility Criteria
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
I have signed the consent form.
My doctor believes I have at least 6 months to live.
1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per AUA recommendation) or 2. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per ASTRO-Phoenix consensus definition).
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Imaging
Participants undergo 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
1 week
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after imaging
52 weeks
Treatment Details
Interventions
- 64Cu-SAR-bisPSMA
Trial Overview The study tests a new PET/CT scan using the tracer 64Cu-SAR-bisPSMA to find where prostate cancer might be returning in the body. Participants may also need a biopsy of any areas that light up on the scan to confirm if it's really cancer.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 64Cu-SAR-bisPSMA 200MBq 64Cu-SAR-bisPSMA.Experimental Treatment1 Intervention
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Who Is Running the Clinical Trial?
Clarity Pharmaceuticals Ltd
Lead Sponsor
Trials
11
Recruited
720+
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