Recruiting
Phase 2

Observational Study

Sponsor:

AdventHealth

Code:

NCT06617481

Conditions

Prostate Cancer (Post Prostatectomy)

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-rhPSMA-7.3 (Posluma)

Study Details

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.

Conditions

Prostate Cancer (Post Prostatectomy)

Study ID

NCT06617481

Start date

Sep 20, 2024

Status verified date

Sep, 2024

Completion date

Oct 10, 2027

Anticipated

Primary completion date

Sep 5, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Open Label Main Arm

Single Arm receiving PET scan with 18F-rhPSMA-7.3 (Posluma)

Interventions

18F-rhPSMA-7.3 (Posluma)

PET Scan using Posluma for detection of early recurrence of prostate cancer.

Primary outcome measure

  • Cancer Detection Rate [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

AdventHealth AdventHealth Oncology Research

407-303-2090CFD.ResearchOncology@AdventHealth.com

Locations

AdventHealth

Recruiting

Orlando, Florida, United States, 32804

Contacts

AdventHealth AdventHealth Oncology Research

407-303-2090CFD.ResearchOncology@AdventHealth.com

More Information

Sponsor

AdventHealth

Last update posted

Oct 24, 2024

Last verified

Sep, 2024

Keywords

  • Rising PSA following cancer prostatectomy surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AdventHealth on 2024-10-24.