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Protocol Details

A Study of Prospective Monitoring of Subjects with Biochemically Recurrent Prostate Cancer Using 18F-DCFPyL

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000628-C

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Female;
Children

Keywords

Cancer Of Prostate;
Natural History;
Imaging

Recruitment Keyword(s)

None

Condition(s)

Prostate Cancer;
Biochemically Recurrent

Investigational Drug(s)

18F-DCFpyL

Investigational Device(s)

None

Intervention(s)

Drug: 18F-DCFpyL

Supporting Site

National Cancer Institute

Background:

Prostate cancer is the second leading cause of cancer-related death in American men. The disease recurs in up to 50,000 men each year after their early-stage disease was treated; however, at this stage, imaging scans are often unable to find the disease in the body. In this natural history study, researchers want to find out if a new radiotracer (18F-DCFPyL) injected before positron emission tomography (PET) imaging can help identify sites in the body with cancer.

Objective:

To learn more about how 18F-DCFPyL PET/CT scans detect change over time in men with recurrent prostate cancer.

Eligibility:

Men aged 18 and older with prostate cancer that returned after treatment.

Design:

Participants will be screened with blood tests. They will also have a bone scan and a computed tomography (CT) scans of the chest, abdomen, and pelvis.

Participants will have an initial study visit. They will have a physical exam and blood tests. They will have a PET/CT scan with 18F-DCFPyL. The radiotracer will be injected into a vein; this will take about 20 seconds. The PET/CT scan will be done 1 to 2 hours later. Participants will lie still on a scanner table while a machine captures images of their body. The scan will take 45 minutes.

Participants will return for blood tests every 3 months.

Participants will return for additional scans with 18F-DCFPyL on this schedule:

Once a year if their previous scan was negative for prostate cancer.

Every 6 months if their previous scan was positive for prostate cancer.

Participants may be in the study up to 5 years.

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Eligibility

INCLUSION CRITERIA:

-History of primary treatment for prostate cancer (either surgery or radiation)

-Serum PSA >= 0.50

-Serum testosterone >100

-Age >=18 years

-Men must agree to use highly effective contraception (surgical sterilization) for 7 days after every study agent administration. Note: abstinence, defined as no heterosexual sexual intercourse when this is in line with the preferred and usual lifestyle of the subject is also acceptable

-The ability of a participant to understand and the willingness to sign a written informed consent document

EXCLUSION CRITERIA:

-Evidence of soft tissue disease on CT scan (or magnetic resonance imaging [MRI] as clinically indicated).

NOTE: Lymph nodes <= 1.5 cm in the shortest dimension are allowed.

-Evidence of bone lesions on Tc99 bone scan

-Prostatectomy within 1 year before the study intervention

-Androgen deprivation therapy (ADT) within the 6 months before the study intervention

-Systemic therapy for prostate cancer within the 6 months before the study intervention


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Ravi A. Madan, M.D.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13N240B
10 Center Drive
Bethesda, Maryland 20892
(301) 480-7168
rm480i@nih.gov

Amy R. Hankin, P.A.-C
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13C432C
10 CENTER DR
BETHESDA MD 20892
(240) 858-3149
amy.hankin@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:

NCT05588128

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