Clinical trial · Interventional
Utility of 18F-rhPSMA-7.3 in the Diagnosis of Prostate Cancer After Focal Gland Treatment
NCT07011342CI-TRIAL-00106197SCOUTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the effectiveness of a PSMA-PET scan in identifying recurrent prostate cancer after focal therapy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-rhPSMA-7.3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-rhPSMA-7.3
- description
- 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.
- interventionNames
- Drug: 18F-rhPSMA-7.3
Primary outcomes (1)
- measure
- To evaluate the effectiveness of PSMA-PET scan in identifying recurrent prostate cancer after focal therapy
- timeFrame
- Approximately 1 year after SOC focal therapy.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (21)
- BACKGROUNDViale 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. PMID 33532112
- BACKGROUNDHopstaken 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
- BACKGROUNDNguyen-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. PMID 27825428
- BACKGROUNDChang SS. Overview of prostate-specific membrane antigen. Rev Urol. 2004;6 Suppl 10(Suppl 10):S13-8. PMID 16985927
- BACKGROUNDCereser 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
- BACKGROUNDKwon DH, Velazquez AI, de Kouchkovsky I. PSMA PET Scan. JAMA Oncol. 2022 Dec 1;8(12):1860. doi: 10.1001/jamaoncol.2022.3531. PMID 36201182
- BACKGROUNDTesta 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
- BACKGROUNDSiegel 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.