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

Phase 2

Recruiting

• Conditions: Prostate Cancer (Post Prostatectomy)
• Interventions: Drug: 18F-rhPSMA-7.3 (Posluma)

• Registration Number: NCT06617481
• Lead Sponsor: AdventHealth

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.

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.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-20
• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-09-26
• Study First Posted: 2024-09-27
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24
• Primary Completion: 2027-09-05
• Study Completion: 2027-10-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label Main Arm	18F-rhPSMA-7.3 (Posluma)	Single Arm receiving PET scan with 18F-rhPSMA-7.3 (Posluma)

Primary Outcome Measures

Name	Time	Method
Cancer Detection Rate	24 months	Patients who undergo at least one rhPSMA-7.3 (18F) PET-scan will be analyzed for the primary endpoint. The malignant lesion detectability rate will be summarized using percentage and 95% confidence interval estimates overall and for those who underwent a single scan or both scans. The diagnostic evaluation aims to identify individuals who are most likely to have an isolated local relapse, as they have the most significant potential for achieving long-term disease control through additional local therapy.

Secondary Outcome Measures

Name	Time	Method
Correlation with biopsy	24 months	In those patients who undergo biopsy of a lesion, correlation with pathology report diagnosis will be reviewed.
Correlation with other imaging modalities	24 months	In those patients who undergo other imaging modalities to confirm the results of the rhPSMA-7.3 (18F) PET-scan, correlation with other imaging modalities will be reviewed.
Response to therapy	24 months	In those patients who undergo cancer directed therapy with radiation alone or with androgen deprivation therapy, the follow-up PSA test values after therapy will be reported.
Adverse Events	24 hours	Safety and toxicity data will be collected to evaluate any patient reported adverse effects. Safety Follow-up Call Within 24 hours of each Injection/Scan

Trial Locations

Locations (1)

AdventHealth; 🇺🇸 Orlando, Florida, United States