Recruiting

PSMA-PET Scan

Sponsor:

Hackensack Meridian Health

Code:

NCT07011342

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-rhPSMA-7.3

Study Details

Brief summary:

To evaluate the effectiveness of a PSMA-PET scan in identifying recurrent prostate cancer after focal therapy

Conditions

Prostate Cancer

Study ID

NCT07011342

Start date

Oct 1, 2025

Status verified date

Mar, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult males 18 years or older;
  • Patient must have a pre-treatment MRI;
  • Patient underwent SOC focal therapy with either focal or hemiablation for the treatment of intermediate risk prostate cancer in the past 9 months prior to enrollment;
  • Intermediate risk disease as defined by American Urology Academy (AUA)/National Comprehensive Cancer Network (NCCN) guidelines (see Appendix A)
  • Life Expectancy of 10 years or more;
  • Underwent standard template biopsy before treatment with a minimum of 2 cores into the MRI visible lesion if lesion was present;
  • Patient understands the purpose of the trial and procedures required for the trial, and can provide signed informed consent as which includes compliances with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol; and
  • Ability to adhere to the study visit schedule and all the protocol requirements, including surveillance imaging and test specimen (blood sample) collection at specified time points.

Exclusion Criteria:

  • Patients under the age of 18 will be considered pediatric patients and will not be included in this study because they are thought to represent a unique population outside the scope of this study as it is aimed at identifying factors that affect adults only.
  • Patients previously treated with whole gland ablation or prior partial gland ablation over 9 months prior to enrollment.

Study Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 18F-rhPSMA-7.3

Patients will undergo a PSMA-PET scan at 1 year (+/- 60 days) after treatment with SOC focal therapy using a radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)-targeted PET scan using 18F-rhPSMA-7.3 (Posluma).

The rhPSMA-targeted PET scan is an FDA-approved PET scan to detect the presence of lesions positive for prostate-specific membrane antigen (PSMA) in men with prostate cancer. 18F-rhPSMA-7.3 (Posluma) injection is a radioactive diagnostic agent that is administered in the form of an intravenous injection.

Interventions

18F-rhPSMA-7.3

Utility of 18F-rhPSMA-7.3 in the diagnosis of prostate cancer after Focal Gland Treatment (SCOUT)

Primary outcome measure

  • To evaluate the effectiveness of PSMA-PET scan in identifying recurrent prostate cancer after focal therapy [ Time Frame: Approximately 1 year after SOC focal therapy. ]

Central Contacts and Locations

Central contacts

Oncology Clinical Research Referral Office

551-996-1777OncologyResearchReferral@hmhn.org

Locations

John Theurer Cancer Center at Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Oncology Clinical Research Referral Office

551-996-1777OncologyResearchReferral@hmhn.org

More Information

Sponsor

Hackensack Meridian Health

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • PSMA-PET

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hackensack Meridian Health on 2026-03-23.