Prostate CancerNCT05588128
Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL
An observational study of Prostate Cancer and Biochemically Recurrent, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Biochemically Recurrent
- What is being tested?
- 18F-DCFpyL
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Primary clinical
Who may be able to join
- 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
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
About this study
Official title: A Study of Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18F-DCFPyL
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.
Read more
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.
Read the detailed description
Background:
- Prostate cancer is the most common malignancy and the second leading cause of cancer-related deaths in American men.
- About 25,000 to 50,000 men each year develop a rising prostate-specific antigen (PSA) after definitive radiation or surgery for early-stage disease but have negative findings on computed tomography (CT) and Tc99 bone scan (standard imaging in prostate cancer).
- The recent Food and Drug Administration (FDA) approval of 18F-DCFPyL PET imaging provides an opportunity to locate micrometastatic lesions in patients with recurrent disease.
- It is unknown how these lesions (or prostate cancer) evolve over time in men with positive findings on 18F-DCFPyL PET imaging.
Objective:
-To observe participants with biochemically recurrent prostate cancer for 5 years to understand the evolution of 18F-DCFPyL PET lesions in this population.
Eligibility:
- History of primary treatment for prostate cancer (either surgery or radiation).
- PSA >= 0.50, and testosterone >100.
- Age >=18 years.
- No evidence of metastatic soft tissue disease on CT scan (or MRI), or bone lesions on bone scan.
- No androgen deprivation therapy (ADT), no systemic therapy within the 6 months before the study intervention, and no prostatectomy within 1 year before the study intervention. Clinical trial treatments are allowable within the 6 months before study intervention.
Design:
- Eligible participants will have clinical evaluations and imaging studies. Participants with negative findings on initial/following 18F-DCFPyL scan(s) will be invited approximately every year (+/-12 weeks) for follow-up imaging studies (including 18F-DCFPyL PET scans). Participants with positive findings on initial/following 18F-DCFPyL scan(s) will be invited approximately every 6 months (+/-8 weeks) for repeat scans, not to exceed 2 scans per year.
- After the initial evaluation, participants will be invited to NIH approximately every 3 months (+/- 4 weeks) for PSA testing.
- Conditions
- Prostate Cancer, Biochemically Recurrent
- Being tested
- 18F-DCFpyL
- Keywords
- Cancer Of Prostate, Natural History, Imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-DCFpyLDrug
Administered to Cohort.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with biochemically recurrent prostate cancer Receives: Drug: 18F-DCFpyL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation of 18F-DCFPyL lesions in BRPC
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.
Measured: baseline through 5 years
Secondary outcomes (2)
Progression on 18F-DCFPyL
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.
Measured: baseline through 5 years
Evaluate PSA doubling in association with 18F-DCFPyL changes
PSA test every 3 months (+/- 4 weeks) until 5 years.
Measured: baseline through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start21 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Melissa L Abel, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588128
- Sponsor's protocol ID
- 10000628
- Other IDs
- 000628-C
- Status last verified
- 13 Oct 2026
- First submitted
- 18 Oct 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing will be shared with subscribers to dbGAP.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18F-DCFPyL
- ClinicalTrials.gov ID
- NCT05588128
- Acronym / sponsor ID
- 10000628
- Conditions
- Prostate Cancer, Biochemically Recurrent
- Keywords
- Cancer Of Prostate, Natural History, Imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
- Prostate cancer is the most common malignancy and the second leading cause of cancer-related deaths in American men.
- About 25,000 to 50,000 men each year develop a rising prostate-specific antigen (PSA) after definitive radiation or surgery for early-stage disease but have negative findings on computed tomography (CT) and Tc99 bone scan (standard imaging in prostate cancer).
- The recent Food and Drug Administration (FDA) approval of 18F-DCFPyL PET imaging provides an opportunity to locate micrometastatic lesions in patients with recurrent disease.
- It is unknown how these lesions (or prostate cancer) evolve over time in men with positive findings on 18F-DCFPyL PET imaging.
Objective:
-To observe participants with biochemically recurrent prostate cancer for 5 years to understand the evolution of 18F-DCFPyL PET lesions in this population.
Eligibility:
- History of primary treatment for prostate cancer (either surgery or radiation).
- PSA >= 0.50, and testosterone >100.
- Age >=18 years.
- No evidence of metastatic soft tissue disease on CT scan (or MRI), or bone lesions on bone scan.
- No androgen deprivation therapy (ADT), no systemic therapy within the 6 months before the study intervention, and no prostatectomy within 1 year before the study intervention. Clinical trial treatments are allowable within the 6 months before study intervention.
Design:
- Eligible participants will have clinical evaluations and imaging studies. Participants with negative findings on initial/following 18F-DCFPyL scan(s) will be invited approximately every year (+/-12 weeks) for follow-up imaging studies (including 18F-DCFPyL PET scans). Participants with positive findings on initial/following 18F-DCFPyL scan(s) will be invited approximately every 6 months (+/-8 weeks) for repeat scans, not to exceed 2 scans per year.
- After the initial evaluation, participants will be invited to NIH approximately every 3 months (+/- 4 weeks) for PSA testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: 18F-DCFpyLParticipants with biochemically recurrent prostate cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary clinical
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-DCFpyLAdministered to Cohort. | Drug | Cohort 1 |
Primary outcome
Observation of 18F-DCFPyL lesions in BRPC
Time frame: baseline 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.
2 secondary outcomes
Progression on 18F-DCFPyL
Time frame: baseline through 5 years
Evaluate PSA doubling in association with 18F-DCFPyL changes
Time frame: baseline through 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing will be shared with subscribers to dbGAP.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa L Abel, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Biochemically Recurrent, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy R Hankin, P.A.-C ((240) 858-3149, amy.hankin@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observation of 18F-DCFPyL lesions in BRPC (time frame: baseline through 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.