NCT06617481 PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence
| NCT ID | NCT06617481 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | AdventHealth |
| Condition | Prostate Cancer (Post Prostatectomy) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-09-20 |
| Primary Completion | 2027-09-05 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2024-09-20 with a primary completion date of 2027-09-05.
⚠ 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
Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer. The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen (PSA) following previous radical prostatectomy surgery.
Eligibility Criteria
Inclusion Criteria: * History of localized adenocarcinoma of the prostate with prior curative intent radical prostatectomy. * An elevated PSA test result that is greater than or equal to 0.1 ng/ml and less than 0.5 Exclusion Criteria: * Patients who are planned to have an x-ray contrast agent or other PET radiotracer \& less than 24 hours prior to the flotufolastat F-18 PSMA-PET scan. * Patients currently receiving Androgen Deprivation Therapy (ADT).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06617481 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer (Post Prostatectomy). 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 NCT06617481 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06617481 currently recruiting?
Yes, NCT06617481 is actively recruiting participants. Contact the research team at CFD.ResearchOncology@AdventHealth.com for enrollment information.
Where is the NCT06617481 trial being conducted?
This trial is being conducted at Orlando, United States.
Who is sponsoring the NCT06617481 clinical trial?
NCT06617481 is sponsored by AdventHealth. The trial plans to enroll 30 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.