Clinical trial NCT05588128: Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL
Official title: A Study of Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18F-DCFPyL
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Biochemically Recurrent
Keywords: Cancer Of Prostate
Natural History
Imaging
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2022-10-20
Enrollment: 350
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary clinical

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.

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.

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.

Eligibility criteria: * 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

Primary outcomes:
measure: Observation of 18F-DCFPyL lesions in BRPC
timeFrame: baseline through 5 years
Secondary outcomes:
measure: Progression on 18F-DCFPyL
timeFrame: baseline through 5 years
measure: Evaluate PSA doubling in association with 18F-DCFPyL changes
timeFrame: baseline through 5 years
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Ravi A Madan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: