18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer

NCT03181867 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 17010917-C-0109
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Prostate Cancer; Prostate Neoplasms; Metastatic Prostate Cancer; Prostatic Cancer; Cancer Of Prostate

Keywords

Endorectal MRI; Imaging; PSMA

Outcome Measures

Primary Outcomes (1)

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

  Correlation between 18F-DCFPyL scanning and accurately staging of high-risk primary prostate cancer and detection of sites of recurrent prostate cancer.

  12 months

Secondary Outcomes (3)

• Evaluate the distribution of 18F-DCFPyL uptake in prostate cancer patients with biochemical relapse (site of recurrence unknown) as a function of PSA value

  12 month

• Compare the distribution of 18F-DCFPyL uptake with multiparametric MRI and whole mount histopathology in patients undergoing prostatectomy

  12 month

• Compare focal 18F-DCFPyL uptake with focal abnormalities identified on standard of care imaging

  12 month

Study Arms (2)

1/Localized High Risk

EXPERIMENTAL

18F-DCFPyL PET/CT imaging, unlabeled PSMA-11 (optional) and possible prostatectomy

Drug: 18F-DCFPyL; Drug: PSMA-11

2/biochemical recurrence (bcr)

EXPERIMENTAL

18F-DCFPyL PET/CT imaging, unlabeled PSMA-11 (optional)

Drug: 18F-DCFPyL; Drug: 18F-FDG; Drug: PSMA-11

Interventions

18F-DCFPyL DRUG

Subjects will receive IV dose of 18F-DCFPyL by bolus injection. The maximum amount of injected active drug will be less than 4.02 mcg. The target administered activity will be 8 mCi.

1/Localized High Risk; 2/biochemical recurrence (bcr)

18F-FDG DRUG

Cohort 2 may receive a one-time 18F-FDG PET/CT after a positive 18F-DCPyL PET/CT. 18F FDG PET/CT imaging may be performed per clinical standard of care. FDG is administered at a dose of 10mCi intravenously. A whole-body PET/CT will be performed beginning post 18F FDG injection.

2/biochemical recurrence (bcr)

PSMA-11 DRUG

For up to 10 eligible patients from either cohort 1 or 2, an optional salivary gland blocking study may be performed in which a salivary gland is cannulated and injected with unlabeled DCFPyL or PSMA-11.

1/Localized High Risk; 2/biochemical recurrence (bcr)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years old.
• Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
• Ability of subject to understand and the willingness to sign a written informed consent document.
• Histologically confirmed adenocarcinoma of the prostate.
• Patients (including those receiving androgen deprivation therapy) fit criteria for one of the following categories:
• Cohort 1 known localized high risk prostate cancer (PSA \>10, Gleason 8-10 or clinical stage \>T2c) with evidence of disease on standard imaging, OR
• Cohort 2 nonspecific or no evidence of disease on standard imaging modality AND biochemical prostate cancer relapse with a PSA greater than or equal to 0.2 ng/mL. Patients must be willing to undergo mandatory research biopsy
• Participants must be co-enrolled on a MIB, UOB, GMB or ROB protocol.
• The effects of 18F-DCFPyL on the developing human fetus are unknown. For this reason, individuals must agree to use adequate contraception with their partner (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and 2 months after 18F-DCFPyL scan. Should a partner become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform the treating physician immediately.

You may not qualify if:

• Subjects for whom participating would significantly delay the scheduled standard of care therapy.
• Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
• Subjects with severe claustrophobia unresponsive to oral anxiolytics
• Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures.
• Subjects weighing greater than 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry.
• Serum creatinine greater than 2 times the upper limit of normal.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Chen Y, Pullambhatla M, Foss CA, Byun Y, Nimmagadda S, Senthamizhchelvan S, Sgouros G, Mease RC, Pomper MG. 2-(3-1-Carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl-ureido)-pentanedioic acid, [18F]DCFPyL, a PSMA-based PET imaging agent for prostate cancer. Clin Cancer Res. 2011 Dec 15;17(24):7645-53. doi: 10.1158/1078-0432.CCR-11-1357. Epub 2011 Oct 31.

  PMID: 22042970 BACKGROUND

• Cho SY, Gage KL, Mease RC, Senthamizhchelvan S, Holt DP, Jeffrey-Kwanisai A, Endres CJ, Dannals RF, Sgouros G, Lodge M, Eisenberger MA, Rodriguez R, Carducci MA, Rojas C, Slusher BS, Kozikowski AP, Pomper MG. Biodistribution, tumor detection, and radiation dosimetry of 18F-DCFBC, a low-molecular-weight inhibitor of prostate-specific membrane antigen, in patients with metastatic prostate cancer. J Nucl Med. 2012 Dec;53(12):1883-91. doi: 10.2967/jnumed.112.104661.

  PMID: 23203246 BACKGROUND

• Szabo Z, Mena E, Rowe SP, Plyku D, Nidal R, Eisenberger MA, Antonarakis ES, Fan H, Dannals RF, Chen Y, Mease RC, Vranesic M, Bhatnagar A, Sgouros G, Cho SY, Pomper MG. Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. Mol Imaging Biol. 2015 Aug;17(4):565-74. doi: 10.1007/s11307-015-0850-8.

  PMID: 25896814 BACKGROUND

• Rowe LS, Harmon S, Horn A, Shankavaram U, Roy S, Ning H, Lindenberg L, Mena E, Citrin DE, Choyke P, Turkbey B. Pattern of failure in prostate cancer previously treated with radical prostatectomy and post-operative radiotherapy: a secondary analysis of two prospective studies using novel molecular imaging techniques. Radiat Oncol. 2021 Feb 10;16(1):32. doi: 10.1186/s13014-020-01733-x.

  PMID: 33568190 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid; Fluorodeoxyglucose F18; PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Peter L Choyke, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 9, 2017
• Study Start: August 3, 2017
• Primary Completion (Estimated): February 1, 2031
• Study Completion (Estimated): February 1, 2031
• Last Updated: April 22, 2026

Record last verified: 2026-04-20

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.

Locations

US (1)