64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer
Clarity Pharmaceuticals Ltd
Summary
The aim for this study is to investigate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. At least 18 years of age. 2. Signed informed consent. 3. Life expectancy ≥ 6 months as determined by the Investigator. 4. Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy. 5. Participant potentially eligible for salvage therapy with curative intent (i.e. aligns with the definition of loco-regional therapy as described in protocol Section 7.2). 6. PSA level after definitive therapy: 1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per…
Interventions
- Drug64Cu-SAR-bisPSMA
All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA
Locations (28)
- East Valley Urology Center of ArizonaMesa, Arizona
- Arkansas Urology Research CenterLittle Rock, Arkansas
- UC IrvineIrvine, California
- Comprehensive Urology Medical GroupLos Angeles, California
- Alarcon Urology CenterMontebello, California
- University of Florida Health- JacksonvilleJacksonville, Florida