18F-DCFPyL PET-CT Scan and Prostate Cancer

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

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer Adenocarcinoma
• Intervention / Treatment: Drug: 18F-DCFPyL

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.

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90073
      • Recruiting
      • VA Greater Los Angeles
      • Contact: Lida Jafari, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Age ≥ 18 years and male.
2. Ability to understand the study and the willingness to sign a written informed consent document.
3. Histologically confirmed adenocarcinoma of the prostate.
4. PSA greater than 10, or Gleason ≥4+3, or clinical stage greater than or equal toT2c.
5. Plan to undergo (or have already undergone) routine care initial systemic staging with conventional imaging for prostate cancer.
6. Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
7. No prior local therapy for prostate cancer (i.e., prostatectomy, radiotherapy, etc.).
8. Willing to comply with the procedural requirements of this protocol.

Exclusion Criteria:

1. Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection.
2. The subject has a condition or situation that, 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.
3. Primary small cell carcinoma of the prostate.
4. Participation in this study significantly delay the scheduled standard of care therapy.
5. Weighs greater than 350 lbs., or unable to fit within the imaging gantry.
6. The subject undergone prior local therapy for prostate cancer (i.e. prostatectomy, radiotherapy, etc.).
7. Currently receiving androgen deprivation therapy (ADT) or anti-androgen? Previous use of ADT is allowed IF the subject has been off ADT or anti-androgen for 3 months or more.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: treatment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging	120 days

Collaborators and Investigators

• Sponsor: Lida Jafari
• Collaborators: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 22, 2018
• Primary Completion (ANTICIPATED): December 30, 2019
• Study Completion (ANTICIPATED): June 30, 2020

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (ACTUAL): February 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Prostate Cancer, PET CT scan, 18F-DCFPyL
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: Jafari0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No