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

NCT03459820 | Enrolling By Invitation Phase 2

• 1 other identifier: 18-002
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Scan positivity fraction in BCR by PSA.

  30 days

• Adverse events

  2 hours

Study Arms (1)

18F-DCFPyL PET/CT

EXPERIMENTAL

18F-DCFPyL PET/CT Scan

Diagnostic Test: 18F-DCFPyL PET/CT

Interventions

18F-DCFPyL PET/CT DIAGNOSTIC_TEST

18F-DCFPyL Positron Emission Tomography/Computed Tomography Scan

18F-DCFPyL PET/CT

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only patients with prostate cancer are included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Nuclear Medicine

Study Record Dates

• First Submitted: March 3, 2018
• First Posted: March 9, 2018
• Study Start: June 22, 2018
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 27, 2023

Record last verified: 2023-11

Locations

CA (1)