NCT06056830 Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
| NCT ID | NCT06056830 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Clarity Pharmaceuticals Ltd |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 383 participants |
| Start Date | 2023-12-21 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 383 participants in total. It began in 2023-12-21 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
Eligibility Criteria
Inclusion Criteria: * At least 18 years of age. * Signed informed consent. * Untreated, histologically confirmed adenocarcinoma of the prostate. * High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.202327 (clinical stage ≥T3a, or Grade Group ≥4, or PSA \>20 ng/mL). * Patients electing to undergo RP with PLND. Exclusion Criteria: * Administration of any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1. * Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components. * Patients with known predominant small cell or neuroendocrine PC.
Contact & Investigator
Clarity Pharmaceuticals
STUDY DIRECTOR
Clarity Pharmaceuticals
Frequently Asked Questions
Who can join the NCT06056830 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06056830 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 383 participants.
Is NCT06056830 currently recruiting?
Yes, NCT06056830 is actively recruiting participants. Contact the research team at clinicaltrials@claritypharmaceuticals.com for enrollment information.
Where is the NCT06056830 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, Little Rock, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT06056830 clinical trial?
NCT06056830 is sponsored by Clarity Pharmaceuticals Ltd. The principal investigator is Clarity Pharmaceuticals at Clarity Pharmaceuticals. The trial plans to enroll 383 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.