NCT06617481

PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence

RhPSMA-7.3(18F)-PET Scan to Detect Prostate Cancer in Patients with Early PSA Recurrence

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: AdventHealth · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is not an investigational study drug. Flotufolastat PET scan is FDA Approved for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. In this research study, the flotufolastat-PET scan will be repeated if the initial scan does not show cancer and if PSA further rises by greater than 0.1 ng/ml. Other currently used scans for this purpose do not detect cancer in all patients with low levels of rising PSA.

Conditions

• Prostate Cancer (Post Prostatectomy)

Interventions

Type	Name	Description
DRUG	18F-rhPSMA-7.3 (Posluma)	PET Scan using Posluma for detection of early recurrence of prostate cancer.

Timeline

• Start date: 2024-09-20
• Primary completion: 2027-09-05
• Completion: 2027-10-10
• First posted: 2024-09-27
• Last updated: 2024-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study