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RecruitingInterventional

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

NCT ID: NCT07011342Sponsor: Hackensack Meridian HealthLast updated: 2026-03-23

Summary

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

Detailed description

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.

Arms & interventions

  • Drug18F-rhPSMA-7.3

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

Outcome measures

Primary

  • 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.

    Time frame: Approximately 1 year after SOC focal therapy.

Secondary

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

    Time frame: Approximately 1 year after SOC focal therapy.

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601

Recruiting
Oncology Clinical Research Referral Office · Contact
551-996-1777OncologyResearchReferral@hmhn.org

References

  • Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available.(PubMed)
  • 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.(PubMed)
  • Nguyen-Nielsen M, Borre M. Diagnostic and Therapeutic Strategies for Prostate Cancer. Semin Nucl Med. 2016 Nov;46(6):484-490. doi: 10.1053/j.semnuclmed.2016.07.002. Epub 2016 Sep 3.(PubMed)
  • Chang SS. Overview of prostate-specific membrane antigen. Rev Urol. 2004;6 Suppl 10(Suppl 10):S13-8.(PubMed)
  • 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.(PubMed)
  • Kwon DH, Velazquez AI, de Kouchkovsky I. PSMA PET Scan. JAMA Oncol. 2022 Dec 1;8(12):1860. doi: 10.1001/jamaoncol.2022.3531.(PubMed)
  • 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.(PubMed)
  • Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.(PubMed)
  • 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.(PubMed)
  • Izawa JI, Klotz L, Siemens DR, Kassouf W, So A, Jordan J, Chetner M, Iansavichene AE. Prostate cancer screening: Canadian guidelines 2011. Can Urol Assoc J. 2011 Aug;5(4):235-40. doi: 10.5489/cuaj.11134. No abstract available.(PubMed)
  • Olleik G, Kassouf W, Aprikian A, Hu J, Vanhuyse M, Cury F, Peacock S, Bonnevier E, Palenius E, Dragomir A. Evaluation of New Tests and Interventions for Prostate Cancer Management: A Systematic Review. J Natl Compr Canc Netw. 2018 Nov;16(11):1340-1351. doi: 10.6004/jnccn.2018.7055.(PubMed)
  • 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.(PubMed)
  • Borley N, Feneley MR. Prostate cancer: diagnosis and staging. Asian J Androl. 2009 Jan;11(1):74-80. doi: 10.1038/aja.2008.19. Epub 2008 Dec 1.(PubMed)
  • Ortner G, Tzanaki E, Rai BP, Nagele U, Tokas T. Transperineal prostate biopsy: The modern gold standard to prostate cancer diagnosis. Turk J Urol. 2021 Feb;47(Supp. 1):S19-S26. doi: 10.5152/tud.2020.20358. Epub 2020 Oct 9.(PubMed)
  • 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.(PubMed)