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

NCT ID: NCT03609736

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-10
• Study Completion Date: 2019-12-31

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: collaborator

Grand River Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Grand River Hospital

Kitchener, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Carla Girolametto

Role: primary

carla.girolametto@grhosp.on.ca

5197494370 ext. 2307

Other Identifiers

PEARL

Identifier Type: -

Identifier Source: org_study_id