Recruiting

18F-DCFPyL

Sponsor:

National Cancer Institute (NCI)

Code:

NCT05588128

Conditions

Prostate Cancer

Biochemically Recurrent

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-DCFpyL

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Biochemically Recurrent

Study ID

NCT05588128

Start date

Mar 21, 2023

Status verified date

Sep 1, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

  • 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. Other investigational agents, excluding those involving standard of care chemotherapy, received within 6 months prior to the study intervention are allowed.

Study Design

Enrollment

350 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

Participants with biochemically recurrent prostate cancer

Interventions

18F-DCFpyL

Administered to Cohort.

Primary outcome measure

  • Observation of 18F-DCFPyL lesions in BRPC [ Time Frame: baseline through 5 years ]

Central Contacts and Locations

Central contacts

Amy R Hankin, P.A.-C

(240) 858-3149amy.hankin@nih.gov

Melissa L Abel, M.D.

(240) 447-5353melissa.abel@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

888-624-1937

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 3, 2026

Last verified

Sep 1, 2026

Keywords

  • Cancer Of Prostate
  • Natural History
  • Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-03.