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

NCT07011342 | Recruiting DMC

• 3 other identifiers: Pro2024-0305SCOUT-IITBED-IIT-479
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Keywords

PSMA-PET

Outcome Measures

Primary Outcomes (1)

• To evaluate the effectiveness of PSMA-PET scan in identifying recurrent prostate cancer after 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.

  Approximately 1 year after SOC focal therapy.

Secondary Outcomes (1)

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

  Approximately 1 year after SOC focal therapy.

Study Arms (1)

18F-rhPSMA-7.3

EXPERIMENTAL

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.

Drug: 18F-rhPSMA-7.3

Interventions

18F-rhPSMA-7.3 DRUG

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

18F-rhPSMA-7.3

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• Blue Earth Diagnostics: collaborator

Study Sites (1)

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Related Publications (21)

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  PMID: 33532112 BACKGROUND

• Hopstaken JS, Bomers JGR, Sedelaar MJP, Valerio M, Futterer JJ, Rovers MM. An Updated Systematic Review on Focal Therapy in Localized Prostate Cancer: What Has Changed over the Past 5 Years? Eur Urol. 2022 Jan;81(1):5-33. doi: 10.1016/j.eururo.2021.08.005. Epub 2021 Sep 4.

  PMID: 34489140 BACKGROUND

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  PMID: 27825428 BACKGROUND

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  PMID: 16985927 BACKGROUND

• Cereser L, Evangelista L, Giannarini G, Girometti R. Prostate MRI and PSMA-PET in the Primary Diagnosis of Prostate Cancer. Diagnostics (Basel). 2023 Aug 17;13(16):2697. doi: 10.3390/diagnostics13162697.

  PMID: 37627956 BACKGROUND

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  PMID: 36201182 BACKGROUND

• Testa U, Castelli G, Pelosi E. Cellular and Molecular Mechanisms Underlying Prostate Cancer Development: Therapeutic Implications. Medicines (Basel). 2019 Jul 30;6(3):82. doi: 10.3390/medicines6030082.

  PMID: 31366128 BACKGROUND

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  PMID: 36633525 BACKGROUND

• Heidenreich A, Bellmunt J, Bolla M, Joniau S, Mason M, Matveev V, Mottet N, Schmid HP, van der Kwast T, Wiegel T, Zattoni F; European Association of Urology. EAU guidelines on prostate cancer. Part 1: screening, diagnosis, and treatment of clinically localised disease. Eur Urol. 2011 Jan;59(1):61-71. doi: 10.1016/j.eururo.2010.10.039. Epub 2010 Oct 28.

  PMID: 21056534 BACKGROUND

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  PMID: 21801679 BACKGROUND

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  PMID: 30442734 BACKGROUND

• Atluri S, Mouzannar A, Venkatramani V, Parekh DJ, Nahar B. Focal therapy for localized prostate cancer - Current status. Indian J Urol. 2022 Jan-Mar;38(1):7-14. doi: 10.4103/iju.iju_166_21. Epub 2022 Jan 1.

  PMID: 35136289 BACKGROUND

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  PMID: 19050692 BACKGROUND

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• Moreira LF, Mussi TC, Cunha MLD, Filippi RZ, Baroni RH. Accuracy of 68Ga-PSMA PET/CT for lymph node and bone primary staging in prostate cancer. Urol Oncol. 2022 Mar;40(3):104.e17-104.e21. doi: 10.1016/j.urolonc.2021.11.007. Epub 2021 Dec 13.

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  PMID: 37444512 BACKGROUND

• Lu, Grace,

  BACKGROUND

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  PMID: 28094848 BACKGROUND

• Eastham JA, Auffenberg GB, Barocas DA, Chou R, Crispino T, Davis JW, Eggener S, Horwitz EM, Kane CJ, Kirkby E, Lin DW, McBride SM, Morgans AK, Pierorazio PM, Rodrigues G, Wong WW, Boorjian SA. Clinically Localized Prostate Cancer: AUA/ASTRO Guideline, Part I: Introduction, Risk Assessment, Staging, and Risk-Based Management. J Urol. 2022 Jul;208(1):10-18. doi: 10.1097/JU.0000000000002757. Epub 2022 May 10.

  PMID: 35536144 BACKGROUND

• National Comprehensive Cancer Network. Prostate Cancer (Version 4.2024). May 17, 2024]; Available from: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf.

  BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Nitin Yerrman, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oncology Clinical Research Referral Office

CONTACT

551-996-1777; OncologyResearchReferral@hmhn.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)