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NCT Number: NCT07011342

Utility of 18F-rhPSMA-7.3 in the Diagnosis of Prostate Cancer After Focal Gland Treatment

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location status: Recruiting

Location contact

Oncology Clinical Research Referral Office

CONTACT

[email protected]

551-996-1777

About this study

PSMA is a protein that is highly expressed in prostate cancer cells, making it an excellent specific target for imaging with PET scans that can provide detailed information about the location, extent and aggressiveness of prostate cancer lesions. These scans have proven invaluable for identifying and characterizing prostate cancer, aiding in treatment planning, and Monitoring treatment response. It's true and fully utility in focal therapy for prostate cancer is unknown.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

18F-rhPSMA-7.3

Drug

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

Primary outcomes

  1. 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.

    All patients will get a biopsy to assess the effectiveness of treatment at 1 year, which is standard protocol at our institutions (all patients undergo biopsy at year 1 and 3 at our institutions). The post-treatment PSMA-PET scan will be correlated to 1-year biopsy results to study the utility of such a scan. Recurrence is defined by a positive PSMA-PET scan and positive biopsy in the area of PET scan tracer uptake at 1 year after SOC focal treatment.

Secondary outcomes

  1. To report the sensitivity and specificity in evaluating PSMA-PET scan

    Time frame: Approximately 1 year after SOC focal therapy.

    Sensitivity and specificity will be reported under the ROC and AUC analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Oncology Clinical Research Referral Office

CONTACT

[email protected]

551-996-1777

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Collaborators

  • Blue Earth Diagnostics

Registry information

Acronym: SCOUT

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 8, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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