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NCT number NCT03181867
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact Yolanda McKinney, R.N.
Phone (301) 443-6913
Email ymckinney@mail.nih.gov
Status Recruiting
Phase Phase 2
Start date August 3, 2017
Completion date October 1, 2020

Clinical Trial Summary

Background:

Prostate cancer is the second leading cause of cancer deaths in American men. When prostate cancer is confined to the prostate there is a high chance of cure. However, it is outside the prostate or comes back after treatment, additional therapy may be needed. Current methods of imaging prostate cancer are limited. Researchers want to see if a radiotracer called 18F-DCFPyL can identify prostate cancer in patients who have a high risk of cancer spreading outside the prostate or who have signs of recurrent cancer after treatment.

Objectives:

To see if the radiotracer 18F-DCFyL can help identify prostate cancer in the body before or after therapy.

Eligibility:

Men ages 18 and older who have prostate cancer that has been newly diagnosed, or has relapsed after radiation or surgery

Design:

Participants will be screened with medical history and physical exam. They will have blood taken.

Participants will be divided into 2 groups.

- Group 1 will be men with cancer that has been newly diagnosed as high risk by their doctor who are scheduled to have prostate removal surgery or undergo biopsy before radiation therapy.

- Group 2 will be men who have presumed prostate cancer relapse after prostate removal surgery or radiation therapy.

Both groups will have scans taken. Participants will lie still on a table in a machine that takes pictures of their body. 18F-DCFyL will be injected by intravenous (IV) line.

Participants will be contacted for follow-up after scans.

Participants in Group 1 may have surgery to remove their prostate gland or a biopsy to remove some prostate tissue. This procedure will be standard of care and is not a part of this study. They will also have an extra MRI scan of their prostate. For this, a tube, called an endorectal coil, will be placed in their rectum. Other tubes may be wrapped around the inside of their pelvis. A contrast agent will be given by IV.

Participants in Group 2 may also undergo an MRI of the pelvis and may have a biopsy of abnormalities found on the 18F-DCFyL scan.

Participants will have data about their prostate cancer collected for up to 1 year.


Clinical Trial Description

Background

- Prostate cancer (PCa) is the second leading cause of cancer death in American men.

- Patients with high risk but apparently localized disease are often understaged because disease beyond the prostate is not well detected and thus leads to overtreatment with prostatectomy

- Recurrence of PCa after surgery or radiation is very common and sometimes progresses to death.

- Early intervention for recurrence has been shown to be of benefit but current methods of localizing recurrence are either insensitive (CT), non-specific (MRI) or both (bone scan) Many prostate cancers express the prostate specific membrane antigen (PSMA) a transmembrane protein with NAALADase (N-acetylated-alphalinked- acidic dipeptidase) and folate hydrolase enzymatic activity. PSMA is also expressed in angiogenesis but otherwise has limited expression in normal tissue.

- An initial test of (18)F-DCFBC, a first-generation PET agent targeting PSMA, in patients with advanced local disease and biochemically recurrent prostate cancer demonstrated the potential of PET to detect sites of recurrence but it was hampered by excessive blood pool activity.

- (18)F-DCFPyL, a second generation PSMA PET agent, binds with high affinity to PSMA yet clears rapidly from the blood pool and thus, whole-body PET imaging with this agent, may provide a new tool in staging high risk cancers and detecting recurrent disease.

Primary Objective

- To assess the ability of (18)F-DCFPyL to accurately stage high-risk primary prostate cancer and detect sites of recurrent prostate cancer.

Eligibility

- Age greater than or equal to 18 years old

- ECOG 0-2 with histologically confirmed adenocarcinoma of the prostate and fits criteria for one of the following:

- Cohort 1

- Patients with known localized high risk prostate cancer (PSA greater than 10, Gleason 8-10 or clinical stage greater than or equal toT2c)

- A multiparametric MRI (standard of care at the NIH Clinical Center) must be performed within 4 months of (18)F-DCFPyL with findings suggestive for high risk prostate cancer.

- Cohort 2

- Nonspecific or no evidence of disease on standard imaging modality AND biochemical prostate cancer relapse with a PSA greater than 0.2 ng/ml

Design

This is a single site study enrolling a total of 330 patients; 55 patients with presumed localized high risk prostate cancer scheduled to undergo prostatectomy or biopsy within 4 months of enrollment and 275 patients with suspected recurrent prostate cancer without definitive evidence of disease on conventional imaging. All patients will undergo a standard of care, clinical multiparametric endorectal coil MRI in the NCI Molecular Imaging Clinic within 4 months of the PET scan.


Study Design


Related Conditions & MeSH terms


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