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
Active, not recruiting
CT.gov ID
NCT04186845
Collaborator
Parexel (Industry)
300
Enrollment
28
Locations
1
Arm
17.9
Anticipated Duration (Months)
10.7
Patients Per Site
0.6
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • Drug: rhPSMA-7.3 (18F) Injection
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 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
Anticipated Study Completion Date :
Nov 1, 2021

Arms and Interventions

ArmIntervention/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

SiteCityStateCountryPostal Code
1University of Alabama at BirminghamBirminghamAlabamaUnited States35233
2Tower UrologyLos AngelesCaliforniaUnited States90048
3University of California Irvine Medical Center (UCIMC)OrangeCaliforniaUnited States92868
4John Wayne Cancer InstituteSanta MonicaCaliforniaUnited States90403
5Emory University HospitalAtlantaGeorgiaUnited States30322
6Northside HospitalAustellGeorgiaUnited States30342
7Northshore University HealthSystemEvanstonIllinoisUnited States60201
8Loyola University Medical CenterMaywoodIllinoisUnited States60153
9Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins UniversityBaltimoreMarylandUnited States21287
10Chesapeake Urology Research AssociatesTowsonMarylandUnited States21204
11University of Michigan Ann ArborAnn ArborMichiganUnited States48109
12Karmanos Cancer InstituteDetroitMichiganUnited States48201
13Washington University School of MedicineSaint LouisMissouriUnited States63110
14Montefiore HospitalBronxNew YorkUnited States10461
15Queens Hospital Center (QHC - Queens Cancer CenterJamaicaNew YorkUnited States11432
16Mount Sinai Faculty Practice AssociatesNew YorkNew YorkUnited States10029
17Stony Brook UniversityStony BrookNew YorkUnited States11794
18Duke University Medical CenterDurhamNorth CarolinaUnited States27701
19University Hospitals Cleveland Medical CenterClevelandOhioUnited States44106
20Cleveland ClinicClevelandOhioUnited States44195
21MidLantic UrologyPhiladelphiaPennsylvaniaUnited States19004
22MD Anderson HospitalHoustonTexasUnited States77054
23Urology San AntonioSan AntonioTexasUnited States78229
24University of Virginia - Health Science CenterCharlottesvilleVirginiaUnited States22908
25Virginia Oncology AssociatesNorfolkVirginiaUnited States23502
26Turku University HospitalTurkuFinlandFI-20520
27CWZNijmegenNetherlands6532
28Maxima MCVeldhovenNetherlands5504 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:
Sep 9, 2021
Last Verified:
Jul 1, 2021
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 Sep 9, 2021