Prostate CancerPhase 3NCT04186845

Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence

A Phase 3 study testing rhPSMA-7.3 (18F) Injection and Positron emission tomography scan in people with Prostate Cancer, run by Blue Earth Diagnostics at 28 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA 7.3 (18F) Positron Emission Tomography (PET) ligand in men with suspected prostate cancer recurrence based on elevated Prostate-specific antigen (PSA) following prior 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?: rhPSMA-7.3 (18F) Injection and Positron emission tomography scan
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 391 participants
Where: 28 sitesin 3 countries
Study dates: 4 May 2020to 28 Apr 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patient is male and aged >18 years old.
History of localized adenocarcinoma of the prostate with prior curative intent treatment.
An elevated PSA, clinically suspicious for biochemically recurrent disease:
Following Radical Prostatectomy: PSA >0.2 ng/mL
Following Radiotherapy: nadir +2 ng/mL.
Potentially eligible for salvage therapy with curative intent.

Who cannot join

Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan.
Patients currently receiving Androgen Deprivation Therapy (ADT).

Trial locations and contacts

28 sites in 3 countries.

Country

City, postcode or hospital

28 sites in 3 countries

United States25 sites

University of Michigan Ann Arbor
Ann Arbor, Michigan, 48109
Emory University Hospital
Atlanta, Georgia, 30322
Northside Hospital
Austell, Georgia, 30342
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of Virginia - Health Science Center
Charlottesville, Virginia, 22908
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
Karmanos Cancer Institute
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27701
Northshore University HealthSystem
Evanston, Illinois, 60201
MD Anderson Hospital
Houston, Texas, 77054
Queens Hospital Center (QHC - Queens Cancer Center
Jamaica, New York, 11432
Tower Urology
Los Angeles, California, 90048
Loyola University Medical Center
Maywood, Illinois, 60153
Mount Sinai Faculty Practice Associates
New York, New York, 10029
Virginia Oncology Associates
Norfolk, Virginia, 23502
University of California Irvine Medical Center (UCIMC)
Orange, California, 92868
MidLantic Urology
Philadelphia, Pennsylvania, 19004
Urology San Antonio
San Antonio, Texas, 78229
John Wayne Cancer Institute
Santa Monica, California, 90403
Washington University School of Medicine
St Louis, Missouri, 63110
Stony Brook University
Stony Brook, New York, 11794
Montefiore Hospital
The Bronx, New York, 10461
Chesapeake Urology Research Associates
Towson, Maryland, 21204

Other trials in United States

Netherlands2 sites

CWZ
Nijmegen, 6532
Maxima MC
Veldhoven, 5504 DB

Other trials in Netherlands

Finland1 site

Turku University Hospital
Turku, FI-20520

Other trials in Finland

About this study

Official title: A Prospective, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Men With Suspected Prostate Cancer Recurrence Based on Elevated PSA Following Prior Therapy (SPOTLIGHT)

Read the detailed description

The primary objective of this study was to assess the patient-level correct detection rate (CDR) and region-level positive predictive value (PPV) of rhPSMA-7.3 (18F) positron emission tomography (PET) for biochemical recurrence (BCR) of prostate cancer using histopathology or imaging as a standard of truth (SoT).

Conditions: Prostate Cancer
Being tested: rhPSMA-7.3 (18F) Injection, Positron emission tomography scan
Keywords: Recurrent Prostate Cancer, Diagnostic, Prostate Specific Membrane Antigen (PSMA), Positron Emission Tomography (PET) Scan
Medical subject headings: Prostatic Neoplasms, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rhPSMA-7.3 (18F) InjectionDrug
Also called flotufolastat F18
Radioligand for PET CT scanning
Positron emission tomography scanDiagnostic test
Also called PET scan
Imaging scan with radioligand

Study groups in NCT04186845
Study group	Role	What they receive
Patients	Experimental	Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan Receives: Drug: rhPSMA-7.3 (18F) Injection; Diagnostic Test: Positron emission tomography scan

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT
The CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any coexisting FP findings. When determining the region-level PPV, all rhPSMA7.3 (18F) PET-positive regions (maximum of three per patient) were categorized as TP or FP regions using histopathology or imaging.
Measured: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan

Secondary outcomes (8)

Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging
Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings.
Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.
Measured: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available
Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings.
Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.
Measured: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level
Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. The last PSA level before the PET scan will be used to stratify the patients
Measured: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other
Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. The analysis was performed for each region and for each of the blinded independent readers
Measured: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes)
This analysis used patients in the EAP who had documented patient management plans in the EDC before and after the rhPSMA-7.3 (18F) PET scan
Measured: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers
The Cohen's kappa statistic will be calculated to assess pairwise agreement between any 2 blinded independent readers
Measured: PET Scan on Day 1
Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level
Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.. The last PSA level before the rhPSMA-7.3 (18F) PET scan was used to stratify patients.
Measured: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available
Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions. The data are analysed by whether the patients have had histopathology as reference standard.
Measured: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 May 202028 Apr 2021

First posted5 Dec 2019
Study start4 May 2020
Primary completion28 Apr 2021
Study completion28 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)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 3
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Model description: Positron Emission Tomography (PET) Imaging study
Masking: None (open label)
Enrolment: 391 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04186845
Sponsor's protocol ID: BED-PSMA-302
Status last verified: Sep 2025
First submitted: 22 Nov 2019
Last updated: 22 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Fleming MT, Hermsen R, Purysko AS, Chau A, Davis P, Chapin BF, Schuster DM. True-Positive 18F-Flotufolastat Lesions in Patients with Prostate Cancer Recurrence with Baseline-Negative Conventional Imaging: Results from the Prospective, Phase 3, Multicenter SPOTLIGHT Study. J Nucl Med. 2024 Jul 1;65(7):1080-1086. doi: 10.2967/jnumed.123.267271.
PubMed 38782456

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Men With Suspected Prostate Cancer Recurrence Based on Elevated PSA Following Prior Therapy (SPOTLIGHT)
ClinicalTrials.gov ID: NCT04186845
Acronym / sponsor ID: BED-PSMA-302
Conditions: Prostate Cancer
Keywords: Recurrent Prostate Cancer, Diagnostic, Prostate Specific Membrane Antigen (PSMA), Positron Emission Tomography (PET) Scan
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 391 participants (actual)
Lead sponsor: Blue Earth DiagnosticsIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 4 May 2020 (actual)
Primary completion: 28 Apr 2021 (actual)
Study completion: 28 Apr 2021 (actual)
First posted: 5 Dec 2019 (actual)
Results: Posted 26 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Positron Emission Tomography (PET) Imaging study

Arm	Type	Receives
Patients	Experimental	Drug: rhPSMA-7.3 (18F) Injection, Diagnostic Test: Positron emission tomography scanSingle intravenous administration of rhPSMA-7.3 (18F) for PET Scan

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patient is male and aged >18 years old.
History of localized adenocarcinoma of the prostate with prior curative intent treatment.
An elevated PSA, clinically suspicious for biochemically recurrent disease:
Potentially eligible for salvage therapy with curative intent.

Key exclusion criteria (2 listed)

Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan.
Patients currently receiving Androgen Deprivation Therapy (ADT).

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
rhPSMA-7.3 (18F) InjectionAlso: flotufolastat F18Radioligand for PET CT scanning	Drug	Patients
Positron emission tomography scanAlso: PET scanImaging scan with radioligand	Diagnostic test	Patients

Primary outcome

Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT
Time frame: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
The CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any coexisting FP findings. When determining the region-level PPV, all rhPSMA7.3 (18F) PET-positive regions (maximum of three per patient) were categorized as TP or FP regions using histopathology or imaging.

8 secondary outcomes

Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging
Time frame: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available
Time frame: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level
Time frame: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other
Time frame: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes)
Time frame: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers
Time frame: PET Scan on Day 1
Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level
Time frame: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available
Time frame: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan

Results and safety

Results posted to the registry on 26 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm	391	378

Primary outcome: Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT

Time frame: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan. Number (95% Confidence Interval). Unit: percentage

Measure	Efficacy Analysis Population (EAP) n = 366
Patient-level CDR - Central Reader 1	54.1 (48.8 to 59.3)
Patient-level CDR - Central Reader 2	51.4 (46.1 to 56.6)
Patient-level CDR - Central Reader 3	51.6 (46.4 to 56.9)
Region-level PPV - Central Reader 1	46.2 (42.0 to 50.3)
Region-level PPV - Central Reader 2	60.3 (55.1 to 65.5)
Region-level PPV - Central Reader 3	52.6 (47.6 to 57.5)

Population analysed: Patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Arm	2 of 391 (0.5%)	28 of 391 (7.2%)	2 of 391

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38782456Fleming MT, Hermsen R, Purysko AS, Chau A, Davis P, Chapin BF, Schuster DM. True-Positive 18F-Flotufolastat Lesions in Patients with Prostate Cancer Recurrence with Baseline-Negative Conventional Imaging: Results from the Prospective, Phase 3, Multicenter SPOTLIGHT Study. J Nucl Med. 2024 Jul 1;65(7):1080-1086. doi: 10.2967/jnumed.123.267271.

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

28 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rhPSMA-7.3 (18F) Injection and Positron emission tomography scan in people with Prostate Cancer, run by Blue Earth Diagnostics at 28 sites in 3 countries.

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 6 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: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States, Netherlands, Finland. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT (time frame: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan). 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 NCT04186845, which also lists 1 linked publication.

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 22 Sep 2025.