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Completed

NCT Number: NCT04186819

Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer.

A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F) Positron Emission Tomography (PET) ligand in men with newly diagnosed prostate cancer.

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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

Main objective is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central blinded image evaluation [BIE]) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during radical prostatectomy (RP) and pelvic lymph node dissection (PLND). At least one positive pelvic LN on PET (N1) and one positive lymph node (LN) as determined by histopathology (pN1) on the same side of the pelvis (left or right) will be deemed a True Positive (TP) at the patient level.

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.
  • Histologically confirmed adenocarcinoma of the prostate.
  • Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).

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, or with a prior history of, Androgen Deprivation Therapy (ADT).

Treatment and study plan

rhPSMA-7.3 (18F) Injection

Drug

Radioligand for PET CT scanning

Other names: No other interventions

Positron emission tomography scan

Diagnostic Test

imaging test with radioligand

Other names: PET scan

Primary outcomes

  1. Specificity

    Time frame: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration

    The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.

  2. Sensitivity

    Time frame: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration

    The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.

Secondary outcomes

  1. Verified Detection Rate (VDR) for M1 Lesions - Percentage of Patients in Whom rhPSMA-7.3 (18F) Imaging Detected at Least One Verified M1 Metastasis, as Determined by Central BIE and Confirmed by SoT (Biopsy or Imaging) (Objective 1)

    Time frame: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET. followed by treatment within 60 days post IMP administration

    This was a key secondary endpoint in this study and included patients in the EEP with rhPSMA-7.3 (18F) imaging.

  2. Percentage of Patients With Negative Conventional Imaging for M1 Disease in Whom rhPSMA-7.3 (18F) PET Detected at Least One Verified M1 Metastasis, as Determined by Central BIE (Objective 2)

    Time frame: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration

    Patients counted in this variable were a subset of those in Point 1 above, where both the numerator and denominator were only counting patients with negative conventional imaging (according to investigator assessment) for M1 disease.

  3. Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3)

    Time frame: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration

    This analysis included patients with rhPSMA-7.3 (18F) imaging and either N1 or M1 lesions detected, where PPV=TP/(TP+FP).

  4. PPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FP Patient is Defined as Having at Least One FP Region (Right or Left Pelvis), Regardless of Any Coexisting TP Findings (Objective 4)

    Time frame: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration

    This analysis included patients in the EAP where rhPSMA-7.3 (18F) imaging detected PLN metastasis. Regions where rhPSMA7.3 (18F) imaging detected no LN metastasis were not included (by definition of PPV), hence only TP and FP regions were considered. TPs were all patients with a surgical pathology confirmed positive region and without a FP region. FP patients were those patients with any rhPSMA7.3 (18F) PETpositive region with negative or no surgical pathology.

  5. NPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FN Patient is Defined as Having at Least One FN Region (Right or Left Pelvis), Regardless of Any Coexisting TN Findings (Objective 5)

    Time frame: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration

    This analysis included patients in the EAP with rhPSMA-7.3 (18F) imaging where no LN metastases were detected and LN surgical pathology was available; where NPV=TN/(TN+FN).

  6. The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a)

    Time frame: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration

    TP [confirmed by SoT] central BIE PET finding and negative conventional imaging finding from the local reading

  7. The Percentage of Patients in Whom Planned RP Was Converted to EBRT. (Objective 6b)

    Time frame: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration

  8. Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7)

    Time frame: PET/CT scans on Day 1

    Pairwise agreement between any 2 of the 3 readers (Kappa statistic could not be calculated for 2 of the pairwise agreements), and within readers between the initial read and re-read (Kappa statistics could not be calculated for 2 of the within-reader agreements)

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) Positron Emission Tomography (PET) Ligand in Men With Newly Diagnosed Prostate Cancer

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 5, 2019
Registry last updated
Feb 26, 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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