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Protocol Details

Evaluation of 18F-DCFPyL PSMA- versus 18F-NaF-PET imaging for Detection of Metastatic Prostate Cancer

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-C-0089

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Enrolling by Invitation
Gender: Male
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Fetuses;
Pregnant Women;
Neonates;
Children;
Female

Keywords

Small Molecule;
Radiolabeled;
PSA;
Diagnostic;
PMSA

Recruitment Keyword(s)

None

Condition(s)

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

Investigational Drug(s)

18F-DCFPyL
18F NaF

Investigational Device(s)

None

Intervention(s)

Drug: 18F-NaF
Drug: 18F-DCFPyL
Drug: 18F-FDG

Supporting Site

National Cancer Institute

Background:

Prostate cancer is the second leading cause of cancer deaths in American men. Few options exist to create images of this type of cancer. Researchers think an experimental radiotracer called 18F-DCFPyL could find sites of cancer in the body.

Objective:

To see if 18F-DCFPyL can identify sites of prostate cancer in people with the disease.

Eligibility:

People ages 18 and older who have metastatic prostate cancer

Design:

Participants will be screened with:

-Blood tests

-Physical exam

-Medical history

Participants will be assigned to 1 of 2 groups based on their PSA.

Participants will have 18F-DCFPyL injected into a vein. About 2 hours later they will have a whole-body Positron Emission

Tomography/Computed Tomography (PET/CT). For the scan, they will lie on their back on the scanner table while it takes pictures of the body. This lasts about 50 minutes.

On another day, participants will have 18F -NaF injected into a vein. About 1 hour later, they will have a whole-body PET/CT.

Participants will be contacted 1 3 days later for follow-up. They may undergo PET/Magnetic Resonance Imaging (MRI) either after having a 18F-DCFPyL PET/CT, or in place of PET/CT imaging. A tube may be placed in the rectum. More coils may be wrapped around the outside of the pelvis.

If the 18F-DCFPyL PET/CT is positive participants will be encouraged to undergo a biopsy of one of the tumors. The biopsy will be taken through a needle put through the skin into the tumor.

Participants will be followed for 1 year. During this time researchers will collect information about their prostate cancer, such as PSA levels and biopsy results.

About 4-6 months after scanning is completed, participants may have a tumor biopsy. The biopsy will be taken through a needle put through the skin into the tumor.

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Eligibility

INCLUSION CRITERIA:

- 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.

- Patients must have confirmation of prostate cancer with identifiable metastatic disease on at least 1 clinically indicated imaging modality. If there is only soft tissue metastasis, one lesion must measure at least 6 mm or greater. OR Documented history of metastatic prostate cancer.

- Patients must be co-enrolled on a UOB, GMB or ROB protocol

- Histological confirmation of prostate cancer

- Patients must be willing to undergo mandatory research biopsy

EXCLUSION CRITERIA:

- 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


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Citations:

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.

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.

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)-pen tanedioic 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.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Peter L. Choyke, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM B3B69F
10 CENTER DR
BETHESDA MD 20892
(240) 760-6093
pchoyke@mail.nih.gov

Yolanda McKinney, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room B3B69E
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6095
ymckinney@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT03173924

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