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Prostate CancerPhase 3NCT04186819

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

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 34 sites in 4 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 Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F) Positron Emission Tomography (PET) ligand in men with newly diagnosed prostate cancer. 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
356 participants
Where
34 sitesin 4 countries
Study dates
2 Mar 2020to 21 Jun 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.
  • Histologically confirmed adenocarcinoma of the prostate.
  • Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).

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

Trial locations and contacts

34 sites in 4 countries.

34 sites in 4 countries

United States29 sites

  • The Urologic Institute of Northeastern New York - Community

    Albany, New York, 12208

  • University of Michigan, Ann Arbor

    Ann Arbor, Michigan, 48109

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Northside Hospital

    Austell, Georgia, 30342

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • 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

  • Richard L Roudebush VA Medical Center

    Indianapolis, Indiana, 46278

  • 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 PC

    Norfolk, Virginia, 23502

  • University of California Irvine Medical Center (UCIMC)

    Orange, California, 92868

  • MidLantic Urology

    Philadelphia, Pennsylvania, 19004

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • 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

Germany2 sites

  • Klinik und Poliklinik fur Urologie

    Hamburg, 20246

  • TU München

    Munich, 81675

Other trials in Germany

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) Positron Emission Tomography (PET) Ligand in Men With 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.

Read the detailed description

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.

Conditions
Prostate Cancer
Being tested
rhPSMA-7.3 (18F) Injection, Positron Emission Tomography scan
Keywords
Primary 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 No other interventions

    Radioligand for PET CT scanning

  • Positron Emission Tomography scanDiagnostic test

    Also called PET scan

    imaging test with radioligand

Study groups in NCT04186819
Study groupRoleWhat they receive
PatientsExperimentalSingle 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.

  1. Specificity

    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.

    Measured: 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

  2. Sensitivity

    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.

    Measured: 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

Secondary outcomes (8)

  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)

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

    Measured: 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

  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)

    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.

    Measured: 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

  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)

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

    Measured: 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

  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)

    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.

    Measured: 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

  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)

    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).

    Measured: 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

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

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

    Measured: 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

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

    Measured: 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)

    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)

    Measured: PET/CT scans on Day 1

Timeline

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

  1. First posted5 Dec 2019
  2. Study start2 Mar 2020
  3. Primary completion21 Jun 2021
  4. Study completion21 Jun 2021

Resources

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
356 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04186819
Sponsor's protocol ID
BED-PSMA-301
Status last verified
Feb 2025
First submitted
22 Nov 2019
Last updated
26 Feb 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Surasi DS, Eiber M, Maurer T, Preston MA, Helfand BT, Josephson D, Tewari AK, Somford DM, Rais-Bahrami S, Koontz BF, Bostrom PJ, Chau A, Davis P, Schuster DM, Chapin BF; LIGHTHOUSE Study Group. Diagnostic Performance and Safety of Positron Emission Tomography with 18F-rhPSMA-7.3 in Patients with Newly Diagnosed Unfavourable Intermediate- to Very-high-risk Prostate Cancer: Results from a Phase 3, Prospective, Multicentre Study (LIGHTHOUSE). Eur Urol. 2023 Oct;84(4):361-370. doi: 10.1016/j.eururo.2023.06.018. Epub 2023 Jul 5.

    PubMed 37414702

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 34 sites in 4 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 3 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 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Germany, 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?

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 study lists 2 primary outcomes in all. 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 NCT04186819, 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 26 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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