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
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2024
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 20, 2024
CompletedFirst Submitted
Initial submission to the registry
September 25, 2024
CompletedFirst Posted
Study publicly available on registry
September 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 10, 2027
October 24, 2024
September 1, 2024
3 years
September 25, 2024
October 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Correlation with biopsy
24 months
Correlation with other imaging modalities
24 months
Response to therapy
24 months
Adverse Events
24 hours
Study Arms (1)
Open Label Main Arm
OTHERSingle Arm receiving PET scan with 18F-rhPSMA-7.3 (Posluma)
Interventions
PET Scan using Posluma for detection of early recurrence of prostate cancer.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- AdventHealthlead
- Blue Earth Diagnosticscollaborator
Study Sites (1)
AdventHealth
Orlando, Florida, 32804, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2024
First Posted
September 27, 2024
Study Start
September 20, 2024
Primary Completion (Estimated)
September 5, 2027
Study Completion (Estimated)
October 10, 2027
Last Updated
October 24, 2024
Record last verified: 2024-09