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Observing Recurrent Prostate Cancer with 18F-DCFPyL PET Scans

This study is for men whose prostate cancer has returned after initial treatment, even if standard scans don't show it. Researchers are using a special imaging agent called 18F-DCFPyL, injected before a PET/CT scan, to see if it can better find cancer spots in the body. The goal is to understand how these cancer spots change over five years. You might be able to join if you're a man aged 18 or older with a history of prostate cancer treatment, and your PSA (prostate-specific antigen) level is 0.50 or higher, and your testosterone is over 100. This is an observational study, meaning researchers will watch how the cancer progresses with the help of 18F-DCFPyL scans.

Study design
This is an observational study with a planned enrollment of 350 participants. It is not specified if it is randomized or blinded.
What's involved
You will have blood tests and receive the 18F-DCFPyL injection for PET/CT scans. You will be observed for up to 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be observed for 5 years to understand the evolution of 18F-DCFPyL PET lesions.

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NCT05588128

Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL

Recruiting
Not specifiedAges 18+Observational
National Cancer Institute (NCI)
~350 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:18F-DCFpyL

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Observation of 18F-DCFPyL lesions in BRPC
Measured over baseline through 5 years

Conditions

Prostate Cancer
Biochemically Recurrent

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Melissa L Abel, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Amy R Hankin, P.A.-C
[email protected]
(240) 858-3149
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Observation of 18F-DCFPyL lesions in BRPCbaseline through 5 years

    Initial 18F-DCFPyL imaging, every 6 months (+/- 8 weeks) for participants positive on imaging, and every 12 months (+/- 12 weeks) for participants negative on imaging until 5 years.