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

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

Study Description

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.

Condition or disease	Intervention/treatment
Prostate Cancer	Diagnostic Test: 18F-DCFPyL PET/CT

Study Design

• Study Type: Observational
• Estimated Enrollment: 12 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: PSMA-based 18F-DCFPyL PET/CT: Evaluating Its Application in Real Life
• Actual Study Start Date: August 10, 2018
• Estimated Primary Completion Date: August 2019
• Estimated Study Completion Date: December 2019

Groups and Cohorts

Intervention Details:

• 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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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 ]
2. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Prostate Cancer Patients
• Accepts Healthy Volunteers: No
• 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.

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.

Contacts and Locations

Locations

Canada, Ontario

Grand River Hospital; Recruiting

Kitchener, Ontario, Canada

Contact: Carla Girolametto 5197494370 ext 2307 carla.girolametto@grhosp.on.ca

Sponsors and Collaborators

Grand River Hospital

St. Joseph's Healthcare Hamilton

More Information

• Responsible Party: Grand River Hospital
• ClinicalTrials.gov Identifier: NCT03609736
• Other Study ID Numbers: PEARL
• First Posted: August 1, 2018
• Last Update Posted: February 15, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases