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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer (Post Prostatectomy)
• Intervention / Treatment: Drug: 18F-rhPSMA-7.3 (Posluma)

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: AdventHealth AdventHealth Oncology Research; Phone Number: 407-303-2090; Email: CFD.ResearchOncology@AdventHealth.com

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32804
      • Recruiting
      • AdventHealth
      • Contact: AdventHealth AdventHealth Oncology Research; Phone Number: 407-303-2090; Email: CFD.ResearchOncology@AdventHealth.com
      • Contact: Guru Sonpavde, MD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Open Label Main Arm; Single Arm receiving PET scan with 18F-rhPSMA-7.3 (Posluma)	Drug: 18F-rhPSMA-7.3 (Posluma); PET Scan using Posluma for detection of early recurrence of prostate cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer Detection Rate	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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation with biopsy	In those patients who undergo biopsy of a lesion, correlation with pathology report diagnosis will be reviewed.	24 months
Correlation with other imaging modalities	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.	24 months
Response to therapy	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.	24 months
Adverse Events	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	24 hours

Collaborators and Investigators

• Sponsor: AdventHealth
• Collaborators: Blue Earth Diagnostics

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Estimated): September 5, 2027
• Study Completion (Estimated): October 10, 2027

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Rising PSA following cancer prostatectomy surgery
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Prostatic Neoplasms; Recurrence
• Other Study ID Numbers: AdventH; IRBNet # 2067493 (Other Identifier: AdventHealth)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Decision to be made at the end of enrollment period of 30 patients

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes