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

Sponsor
Blue Earth Diagnostics (Industry)
Overall Status
Completed
CT.gov ID
NCT04186845
Collaborator
Parexel (Industry)
391
28
1
17.2
14
0.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: rhPSMA-7.3 (18F) Injection
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
391 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Positron Emission Tomography (PET) Imaging studyPositron Emission Tomography (PET) Imaging study
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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.
Actual Study Start Date :
May 5, 2020
Actual Primary Completion Date :
Apr 9, 2021
Actual Study Completion Date :
Oct 12, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients

Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan

Drug: rhPSMA-7.3 (18F) Injection
Radioligand for PET CT scanning

Outcome Measures

Primary Outcome Measures

  1. Positive Predictive Value (PPV) of rhPSMA-7.3 (18F) PET on a patient level using histopathology or confirmatory imaging as a Standard of Truth (SoT). [90 days]

    PPV (defined as true positive [TP]/{TP+false positive [FP]}) of rhPSMA-7.3 (18F) PET using histopathology or confirmatory imaging as a Standard of Truth (SoT).

Secondary Outcome Measures

  1. Inter-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers. [90 days]

    Kappa statistic for the agreement between blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans.

  2. Intra-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers. [90 days]

    Kappa statistic for the agreement within blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans.

  3. Number of participants with treatment-related adverse events as classified by MedDRA [90 days]

    Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F-rhPSMA-7.3 throughout the study period.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

  1. 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35233
2 Tower Urology Los Angeles California United States 90048
3 University of California Irvine Medical Center (UCIMC) Orange California United States 92868
4 John Wayne Cancer Institute Santa Monica California United States 90403
5 Emory University Hospital Atlanta Georgia United States 30322
6 Northside Hospital Austell Georgia United States 30342
7 Northshore University HealthSystem Evanston Illinois United States 60201
8 Loyola University Medical Center Maywood Illinois United States 60153
9 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University Baltimore Maryland United States 21287
10 Chesapeake Urology Research Associates Towson Maryland United States 21204
11 University of Michigan Ann Arbor Ann Arbor Michigan United States 48109
12 Karmanos Cancer Institute Detroit Michigan United States 48201
13 Washington University School of Medicine Saint Louis Missouri United States 63110
14 Montefiore Hospital Bronx New York United States 10461
15 Queens Hospital Center (QHC - Queens Cancer Center Jamaica New York United States 11432
16 Mount Sinai Faculty Practice Associates New York New York United States 10029
17 Stony Brook University Stony Brook New York United States 11794
18 Duke University Medical Center Durham North Carolina United States 27701
19 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
20 Cleveland Clinic Cleveland Ohio United States 44195
21 MidLantic Urology Philadelphia Pennsylvania United States 19004
22 MD Anderson Hospital Houston Texas United States 77054
23 Urology San Antonio San Antonio Texas United States 78229
24 University of Virginia - Health Science Center Charlottesville Virginia United States 22908
25 Virginia Oncology Associates Norfolk Virginia United States 23502
26 Turku University Hospital Turku Finland FI-20520
27 CWZ Nijmegen Netherlands 6532
28 Maxima MC Veldhoven Netherlands 5504 DB

Sponsors and Collaborators

  • Blue Earth Diagnostics
  • Parexel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Blue Earth Diagnostics
ClinicalTrials.gov Identifier:
NCT04186845
Other Study ID Numbers:
  • BED-PSMA-302
First Posted:
Dec 5, 2019
Last Update Posted:
Mar 17, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Blue Earth Diagnostics
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2022