Recruiting
Phase 2
Phase 3

18F-DCFPyL PET-CT

Sponsor:

Lida Jafari

Code:

NCT03852654

Conditions

Prostate Cancer Adenocarcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-DCFPyL

Study Details

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.

Conditions

Prostate Cancer Adenocarcinoma

Study ID

NCT03852654

Start date

Jul 22, 2018

Status verified date

Feb, 2019

Completion date

Jun 30, 2020

Anticipated

Primary completion date

Dec 30, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

170 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: treatment

Interventions

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 measure

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

Central Contacts and Locations

Central contacts

Jafari Lida, M.D.

310 268 3583lida.jafari@va.gov

Nicholas G Nickols, M.D., Ph.D.

310 268 3390nicholas.nickols@va.gov

Locations

VA Greater Los Angeles

Recruiting

Los Angeles, California, United States, 90073

More Information

Sponsor

Lida Jafari

Last update posted

Feb 25, 2019

Last verified

Feb, 2019

Keywords

  • Prostate Cancer, PET CT scan, 18F-DCFPyL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Lida Jafari on 2019-02-25.