TriangleNCT04186845 · CITED IN SOURCE DOCUMENTS
Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2025-09-22
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging
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 of rhPSMA-7.3 (18F) PET Stratified by PSA Level
CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other
Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes)
Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers
Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level
Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: 1. Patient is male and aged \>18 years old. 2. History of localized adenocarcinoma of the prostate with prior curative intent treatment. 3. An elevated PSA, clinically suspicious for biochemically recurrent disease: * Following Radical Prostatectomy: PSA \>0.2 ng/mL * Following Radiotherapy: nadir +2 ng/mL. 4. Potentially eligible for salvage therapy with curative intent. Exclusion Criteria: 1. Patients who are planned to have an x-ray contrast agent or other PET radiotracer \<24 hours prior to the PET scan. 2. Patients currently receiving Androgen Deprivation Therapy (ADT).
- gender Based
- true
- gender Description
- Patients required to have suspected prostate cancer recurrence based on elevated PSA following prior therapy.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- MALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
- intervention Names
- Drug: rhPSMA-7.3 (18F) Injection
- Diagnostic Test: Positron emission tomography scan
- label
- Patients
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Patients
- description
- Radioligand for PET CT scanning
- name
- rhPSMA-7.3 (18F) Injection
- other Names
- flotufolastat F18
- type
- DRUG
- arm Group Labels
- Patients
- description
- Imaging scan with radioligand
- name
- Positron emission tomography scan
- other Names
- PET scan
- type
- DIAGNOSTIC_TEST
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- intervention Model Description
- Positron Emission Tomography (PET) Imaging study
- masking Info
- masking
- NONE
- primary Purpose
- DIAGNOSTIC
Enrollment
- count
- 391
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- 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
- secondary Outcomes
- description
- 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.
- measure
- 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
- description
- 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.
- measure
- 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
- description
- 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
- measure
- 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
- description
- 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
- measure
- 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
- description
- 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
- measure
- 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
- description
- The Cohen's kappa statistic will be calculated to assess pairwise agreement between any 2 blinded independent readers
- measure
- Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers
- time Frame
- PET Scan on Day 1
- description
- 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.
- measure
- 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
- description
- 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.
- measure
- 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
Full study description
- brief 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.
- 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).
Source references
- references
- citation
- 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.
- pmid
- 38782456
- type
- DERIVED
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-da8a8db91edda4464e06
- requested nct id
- NCT04186845
- primary nct id
- NCT04186845
- source kind
- fda_spl_label
- source record id
- 67cbcafa-00b3-41fd-986d-1159706273f3
- source file sha256
- a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
- payload sha256
- b4e12d94df45576d466aac684a0057d3d6b0f38f64846b7d83ce1688fed88002
- payload
- application numbers
- NDA216023
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-da8a8db91edda4464e06
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT04186845
- occurrences
- context exact
- ate consensus panel or histopathology. 14.2 Imaging for Suspected Recurrence of Prostate Cancer The safety and efficacy of POSLUMA were evaluated in SPOTLIGHT (NCT04186845), a prospective, multicenter, open-label, single-arm study in patients with biochemical evidence of recurrent prostate cancer. The study enrolled 391 patients
- end
- 3761
- exact text
- NCT04186845
- start
- 3750
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00400.json
- source file sha256
- a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
- source json pointer
- /results/22/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- 67cbcafa-00b3-41fd-986d-1159706273f3
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 089f3a958540aed82712a76aaa3989b27c9dc2e66ffb6436b5c184a16cf86a7d
- spl effective time
- 20260725
- spl set id
- 907ac4a4-a088-4826-ab50-cfc31985c9d4
Preserved source evidence · Not medical advice