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PSMA-based 18F-DCFPyL PET/CT: Evaluating Its Application in Real Life (PEARL)

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ClinicalTrials.gov Identifier: NCT03609736
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
Grand River Hospital

Tracking Information
First Submitted Date July 25, 2018
First Posted Date August 1, 2018
Last Update Posted Date February 15, 2019
Actual Study Start Date August 10, 2018
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 31, 2018)
To acquire pilot data on the use of 18F-DCFPyL PET/CT following conventional imaging (CT and bone scan) for the detection of metastases in men with prostate cancer [ Time Frame: 1 year ]
To acquire pilot data on the use of 18F-DCFPyL PET/CT following conventional imaging (CT and bone scan) for the detection of metastases in men with prostate cancer when: 1. The CT scan shows indeterminate lymph node(s) in the pelvis that could potentially be treated radically with radiotherapy if found to be positive on 18F-DCFPyL PET/CT; 2. The subject is suspected to have oligometastatic disease (< 4 sites of disease) that could potentially be treated with stereotactic/ radical doses of radiotherapy.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 31, 2018)
  • To acquire pilot data comparing the number and location of metastatic lesions on 18F-DCFPyL PET/CT with standard of care imaging (CT and bone scan). [ Time Frame: 1 year ]
  • To acquire pilot data on the change in management plans resulting from 18F-DCFPyL PET/CT compared with standard of care imaging (CT and bone scan). [ Time Frame: 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PSMA-based 18F-DCFPyL PET/CT: Evaluating Its Application in Real Life
Official Title PSMA-based 18F-DCFPyL PET/CT: Evaluating Its Application in Real Life
Brief Summary The purpose of the study is to provide pilot data on the clinical situations in which ordering a 18F-DCFPyL positron emission tomography/computed tomography (PET/CT) was thought to be clinically useful, and to document how the results of the 18F-DCFPyL PET/CT affected patient management. The results of this study could then serve as a guide to help OHIP to consider these scenarios when deciding the precise indications for funded 18F-DCFPyL PET/CT scans in the future. In this study the investigators will image subjects with prostate cancer using 18F-DCFPyL PET/CT and record how the result of the study affected patient management.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This study will image male subjects with PCa using 18F-DCFPyL PET/CT for detection of disease with correlation to standard-of-care imaging (CT and bone scan) and clinical follow-up over a 1-year time period.
Condition Prostate Cancer
Intervention Diagnostic Test: 18F-DCFPyL PET/CT
  • A bolus of less than or equal to 9 mCi (333 MBq) of 18F-DCFPyL will be injected IV by slow IV push.
  • After administration of the 18F-DCFPyL the line will be flushed with saline (0.9% w/v).
  • Subjects should be encouraged to drink up to 500 mL of water shortly after the administration of 18F-DCFPyL.
  • At 60-minutes (± 10 minutes) after administration of 18F-DCFPyL, the PET/CT scan will be acquired with the subject in the supine position and the FOV including the mid-thighs to skull base.
Study Groups/Cohorts Not Provided
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 Recruiting
Estimated Enrollment
 (submitted: July 31, 2018)
12
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Willing and able to provide written informed consent
  • Age ≥ 18 years and male
  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • One of the following:
  • CT scan showing indeterminate lymph node(s) in the pelvis that could potentially be treated radically with radiotherapy if found to be positive on PSMA PET.
  • Suspected oligometastatic disease (< 4 sites of disease) that could potentially be treated with stereotactic/radical doses of radiotherapy.

Exclusion Criteria:

  • Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
  • Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg)
  • Condition or situation which, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study
  • Not willing to comply with the procedural requirements of this protocol
  • Subjects who have partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration.
Sex/Gender
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Prostate Cancer Patients
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03609736
Other Study ID Numbers PEARL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Grand River Hospital
Study Sponsor Grand River Hospital
Collaborators St. Joseph's Healthcare Hamilton
Investigators Not Provided
PRS Account Grand River Hospital
Verification Date February 2019