Prostate Cancer Patient Management With 18F-DCFPyL PET/CT

Prostate Cancer Clinical Trial

Official title:

Differences in Optimal Prostate Cancer Patient Management as Proposed by a Panel of Experts Before and After 18F-DCFPyL PET/CT

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03459820
• Other study ID #: 18-002
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• Start date: June 22, 2018
• Est. completion date: June 2028

Study information

• Verified date: November 2023
• Source: Sir Mortimer B. Davis - Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, single-arm, open-label, phase III trial in patients with biopsy-proven prostate cancer. Patients will receive regular standard of clinical care. The only study-specific procedures will the administration of 18F-DCFPyL followed by a PET/CT scan. Differences in theoretical optimal clinical management based on a review of clinical, biochemical and radiographic subject data before and after 18F-DCFPyL PET/CT imaging by a central panel of experts will be captured at study completion.

Description:

Objectives: The primary objective of this study is to assess the differences in theoretical optimal clinical management afforded by 18F-DCFPyL PET/CT in prostate cancer patients as proposed by a central panel of experts.

Primary endpoint:

1. Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts.

Secondary endpoints:

1. 18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA.

2. Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1500
• Est. completion date: June 2028
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male sex

• Age 18 years or older

• Previously diagnosed with prostate cancer, under referring physician's care

• ECOG performance status 0 - 3, inclusive

• Able to understand and provide written informed consent

• Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection

Cohort A - High risk staging (HRS): Staging of high risk not previously treated patients as defined by any one of the following:

• Gleason score > 7

• Serum PSA > 15 ng/ml

• T stage of T3 or greater on TNM staging

• Equivocal/inconclusive conventional staging such as CT, MRI or bone scan

• Clinical suspicion of advance stage disease (e.g. bone pain)

Cohort B - Biochemical recurrence: Restaging of biochemically recurrent prostate cancer patients as defined by increasing serum PSA on serial measurements and current PSA above 0.1 ng/ml following any treatment for prostate cancer.

Exclusion Criteria:

• Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)

• Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter)

• Patients with unmanageable claustrophobia

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• 18F-DCFPyL PET/CT
18F-DCFPyL Positron Emission Tomography/Computed Tomography Scan

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Sir Mortimer B. Davis - Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in optimal clinical management	Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts.	30 days
Secondary	Scan positivity fraction in BCR by PSA.	18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA.	30 days
Secondary	Adverse events	Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.	2 hours