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Completed

NCT Number: NCT04186845

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

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.

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Key information

Conditions

Prostate Cancer Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Turku University Hospital, Turku, Finland

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

rhPSMA-7.3 (18F) Injection

Drug

Radioligand for PET CT scanning

Other names: flotufolastat F18

Positron emission tomography scan

Diagnostic Test

Imaging scan with radioligand

Other names: PET scan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 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.

  2. 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 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.

  3. 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

    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

  4. 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

    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

  5. 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

    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

  6. Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers

    Time frame: PET Scan on Day 1

    The Cohen's kappa statistic will be calculated to assess pairwise agreement between any 2 blinded independent readers

  7. 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 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.

  8. 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

    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.

Sponsors and collaborators

Lead sponsor

Blue Earth Diagnostics

Industry

Collaborators

  • Parexel

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 5, 2019
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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