NCT03852654

18F-DCFPyL PET-CT Scan and Prostate Cancer

A Novel 18F-DCFPyL PET-CT Scan for Diagnosis and Management of Prostate Cancer

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Lida Jafari · Federal
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: The primary objective of this study is to assess the efficacy of 18F-DCFPyL PET-CT for initial staging of prostate cancer in Veterans compared to conventional imaging (99mTc-MDP bone scan and Diagnostic CT or MRI). The primary clinical endpoint of our study is the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging. Secondary Objectives: Frequency of the change in primary treatment plan after initial staging.

Detailed description

This is a single arm Phase II clinical trial in Veterans with prostate cancer, no prior local therapy, who are at risk of having metastatic disease (PSA greater than 10, or Gleason Score greater than or equal to 4+3, or clinical stage greater than or equal to T2c). Veterans who are planned to undergo or have recently undergone conventional, routine care initial staging scans for prostate cancer (99mTc-MDP or NaF PET bone scan and diagnostic CT or MRI of pelvis) will also receive a 18F-DCFPyL PET-CT scan. The primary endpoint is the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT scan identifies evidence of M1 disease at initial staging.

Conditions

• Prostate Cancer Adenocarcinoma

Interventions

Type	Name	Description
DRUG	18F-DCFPyL	Subjects with biopsy proven prostate cancer, no prior local therapy, and: PSA ≥ 10 ng/dl, or Gleason Sum ≥ 4+3, or clinical stage ≥cT2c Staging by 99mTc-MDP or NaF PET bone scan, and Diagnostic CT (pelvis) or MRI will undergo 18F DCFPyL PET CT scan.

Timeline

• Start date: 2018-07-22
• Primary completion: 2019-12-30
• Completion: 2020-06-30
• First posted: 2019-02-25
• Last updated: 2019-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study