Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Test-Retest Reproducibility of 18F-DCFPyL PET/CT in the Evaluation of Patients With Metastatic Prostate Cancer

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03793543
Recruitment Status : Completed
First Posted : January 4, 2019
Last Update Posted : December 15, 2021
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
In this study, the investigators intend to validate 18F-DCFPyL test-retest reproducibility in metastatic lesions, in order to investigate whether it serves as a reliable response assessment tool, both to interpret existing studies and to design future longitudinal trials.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 18F-DCFPyL Injection Phase 1

Detailed Description:
The investigators will image patients with widely metastatic castration-sensitive (CSPC) or castration-resistant prostate cancer (CRPC) using 18F-DCFPyL-PET/CT for detection of tumor burden and perform a lesion-based head-to-head comparison with a subsequent near-term (one to seven days) 18F-DCFPyL-PET/CT follow-up scan, to assess test-retest reproducibility of this second-generation PSMA-targeted compound. Second, as it has not been specifically investigated with this compound before, intra-observer agreement as well as inter-scan variability will be assessed.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Test-Retest Reproducibility of 18F-DCFPyL PET/CT in the Evaluation of Patients With Metastatic Prostate Cancer - an Interscan Variability and Intraobserver Agreement Study
Actual Study Start Date : March 27, 2019
Actual Primary Completion Date : March 6, 2020
Actual Study Completion Date : October 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 18F-DCFPyL Injection
9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
Drug: 18F-DCFPyL Injection
A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL




Primary Outcome Measures :
  1. Change in number of metastatic lesions detected on on 18F-DCFPyL PET/CT from baseline [ Time Frame: Change from baseline to up to 4 weeks ]
    Change in number of metastatic lesions detected on 18F-DCFPyL PET/CT at baseline with a subsequent near-term 18F-DCFPyL PET/CT scan.

  2. Test the intraobserver agreement as assessed by percentage of scans that are read the same on second read [ Time Frame: 3 years ]
    The scans of every patient completing the 2 imaging time points will be reread by the same reader about 4 weeks after the first reading.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to provide written informed consent
  • History of histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
  • Patients with metastatic castration-sensitive (CSPC) or castration-resistant prostate cancer (CRPC) with evidence of metastatic disease on conventional imaging with CT or bone scan.
  • Prior docetaxel-based chemotherapy is permitted
  • Documented metastatic prostate cancer progression as assessed by the treating oncologist with either one or both of the following and has not initiated a new therapy after determination of progression: Rising PSA over a minimum 1-week interval and/or radiographic progression in soft tissue and bone metastases (combination of bony and soft tissue metastases)
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Exclusion Criteria:

  • Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
  • Administered a radioisotope ≤5 physical half-lives prior to the date of study PET/CT
  • Administered IV X-ray contrast medium ≤24 hours prior to the date of study PET/CT
  • Administered oral contrast medium ≤120 hours prior to the date of study PET/CT
  • Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793543


Locations
Layout table for location information
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
Layout table for investigator information
Principal Investigator: Steven Rowe, M.D., Ph.D. Johns Hopkins University
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03793543    
Other Study ID Numbers: J18127
IRB00174393 ( Other Identifier: JHM IRB )
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
J18127 PSMA PyL 18F-DCFPyL PET/CT
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases