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18F-DCFPyL PET-CT Scan and Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03852654
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Lida Jafari, VA Greater Los Angeles Healthcare System

Brief 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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Adenocarcinoma Drug: 18F-DCFPyL Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Novel 18F-DCFPyL PET-CT Scan for Diagnosis and Management of Prostate Cancer
Actual Study Start Date : July 22, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging [ Time Frame: 120 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852654


Contacts
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Contact: Jafari Lida, M.D. 310 268 3583 lida.jafari@va.gov
Contact: Nicholas G Nickols, M.D., Ph.D. 310 268 3390 nicholas.nickols@va.gov

Locations
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United States, California
VA Greater Los Angeles Recruiting
Los Angeles, California, United States, 90073
Contact: Lida Jafari, M.D.         
Sponsors and Collaborators
Lida Jafari
University of California, Los Angeles

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Responsible Party: Lida Jafari, Nuclear Medicine Physician, VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier: NCT03852654     History of Changes
Other Study ID Numbers: Jafari0001
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lida Jafari, VA Greater Los Angeles Healthcare System:
Prostate Cancer, PET CT scan, 18F-DCFPyL

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Genital Diseases, Male
Carcinoma