Prostate CancerSCOUTNCT07011342
Utility of 18F-rhPSMA-7.3 in the Diagnosis of Prostate Cancer After Focal Gland Treatment
A study testing 18F-rhPSMA-7.3 in people with Prostate Cancer, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
To evaluate the effectiveness of a PSMA-PET scan in identifying recurrent prostate cancer after focal therapy Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 18F-rhPSMA-7.3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Oncology Clinical Research Referral Office, 551-996-1777, OncologyResearchReferral@hmhn.org
About this study
To evaluate the effectiveness of a PSMA-PET scan in identifying recurrent prostate cancer after focal therapy
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- 18F-rhPSMA-7.3
- Keywords
- PSMA-PET
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-rhPSMA-7.3Drug
Utility of 18F-rhPSMA-7.3 in the diagnosis of prostate cancer after Focal Gland Treatment (SCOUT)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 18F-rhPSMA-7.3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 1 year after SOC focal therapy.
Secondary outcomes (1)
To report the sensitivity and specificity in evaluating PSMA-PET scan
Sensitivity and specificity will be reported under the ROC and AUC analysis.
Measured: Approximately 1 year after SOC focal therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 Oct 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Responsible party
- Sponsor
- Investigators
- Nitin Yerrman, MD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011342
- Sponsor's protocol ID
- Pro2024-0305
- Other IDs
- SCOUT-IIT, BED-IIT-479
- Acronym
- SCOUT
- Status last verified
- Mar 2026
- First submitted
- 30 May 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 33532112Hopstaken 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 34489140Nguyen-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 27825428Chang SS. Overview of prostate-specific membrane antigen. Rev Urol. 2004;6 Suppl 10(Suppl 10):S13-8.
PubMed 16985927Cereser 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 37627956Kwon DH, Velazquez AI, de Kouchkovsky I. PSMA PET Scan. JAMA Oncol. 2022 Dec 1;8(12):1860. doi: 10.1001/jamaoncol.2022.3531.
PubMed 36201182Testa 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 31366128Siegel 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 36633525Heidenreich 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 21056534Izawa 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 21801679Olleik 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 30442734Atluri 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 35136289Borley 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 19050692Ortner 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 33052837Moreira 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 34911650
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of 18F-rhPSMA-7.3 in the Diagnosis of Prostate Cancer After Focal Gland Treatment
- ClinicalTrials.gov ID
- NCT07011342
- Acronym / sponsor ID
- SCOUT / Pro2024-0305
- Conditions
- Prostate Cancer
- Keywords
- PSMA-PET
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-rhPSMA-7.3 | Experimental | Drug: 18F-rhPSMA-7.3Patients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-rhPSMA-7.3Utility of 18F-rhPSMA-7.3 in the diagnosis of prostate cancer after Focal Gland Treatment (SCOUT) | Drug | 18F-rhPSMA-7.3 |
Primary outcome
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.
1 secondary outcome
To report the sensitivity and specificity in evaluating PSMA-PET scan
Time frame: Approximately 1 year after SOC focal therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Background: PubMed 33532112Viale 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.
- Background: PubMed 34489140Hopstaken 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.
- Background: PubMed 27825428Nguyen-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.
- Background: PubMed 16985927Chang SS. Overview of prostate-specific membrane antigen. Rev Urol. 2004;6 Suppl 10(Suppl 10):S13-8.
- Background: PubMed 37627956Cereser 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.
- Background: PubMed 36201182Kwon DH, Velazquez AI, de Kouchkovsky I. PSMA PET Scan. JAMA Oncol. 2022 Dec 1;8(12):1860. doi: 10.1001/jamaoncol.2022.3531.
- Background: PubMed 31366128Testa 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.
- Background: PubMed 36633525Siegel 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.
- Background: PubMed 21056534Heidenreich 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.
- Background: PubMed 21801679Izawa 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.
- Background: PubMed 30442734Olleik 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.
- Background: PubMed 35136289Atluri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nitin Yerrman, MD principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-rhPSMA-7.3 in people with Prostate Cancer, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oncology Clinical Research Referral Office (551-996-1777, OncologyResearchReferral@hmhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07011342, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.