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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04186845
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : December 4, 2020
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Blue Earth Diagnostics

Tracking Information
First Submitted Date  ICMJE November 22, 2019
First Posted Date  ICMJE December 5, 2019
Last Update Posted Date December 4, 2020
Actual Study Start Date  ICMJE May 5, 2020
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2019)
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). [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2019)
  • Inter-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers. [ Time Frame: 90 days ]
    Kappa statistic for the agreement between blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans.
  • Intra-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers. [ Time Frame: 90 days ]
    Kappa statistic for the agreement within blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans.
  • Number of participants with treatment-related adverse events as classified by MedDRA [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imaging Study to Investigate Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Suspected Prostate Cancer Recurrence (SPOTLIGHT)
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Positron Emission Tomography (PET) Imaging study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Drug: rhPSMA-7.3 (18F) Injection
Radioligand for PET CT scanning
Study Arms  ICMJE Experimental: Patients
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
Intervention: Drug: rhPSMA-7.3 (18F) Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 2, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  4. 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Patients required to have suspected prostate cancer recurrence based on elevated PSA following prior therapy.
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jingke Yang, MD +1 978 313 3834 Jingke.Yang@parexel.com
Contact: Francesco Paronelli +39 0332 732603 Francesco.Paronelli@parexel.com
Listed Location Countries  ICMJE Finland,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04186845
Other Study ID Numbers  ICMJE BED-PSMA-302
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Blue Earth Diagnostics
Study Sponsor  ICMJE Blue Earth Diagnostics
Collaborators  ICMJE Parexel
Investigators  ICMJE Not Provided
PRS Account Blue Earth Diagnostics
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP