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

• ClinicalTrials.gov Identifier: NCT05588128
• Recruitment Status: Recruiting
• First Posted: October 20, 2022
• Last Update Posted: March 15, 2024
• Sponsor: National Cancer Institute (NCI)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information

• First Submitted Date: October 18, 2022
• First Posted Date: October 20, 2022
• Last Update Posted Date: March 15, 2024
• Actual Study Start Date: March 21, 2023
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 27, 2024)

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.

Original Primary Outcome Measures (submitted: October 19, 2022)

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

Initial 18F-DCFPyL imaging, every 6 months (+/-2 weeks) for participants positive on imaging, and every 12 months (+/- 2 months) for participants negative on imaging until 5 years.

Current Secondary Outcome Measures (submitted: January 27, 2024)

• Progression on 18F-DCFPyL [ 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.
• Evaluate PSA doubling in association with 18F-DCFPyL changes [ Time Frame: baseline through 5 years ]
  PSA test every 3 months (+/- 4 weeks) until 5 years.

Original Secondary Outcome Measures (submitted: October 19, 2022)

• Progression on 18F-DCFPyL [ Time Frame: baseline through 5 years ]
  Initial 18F-DCFPyL imaging, every 6 months (+/-2 weeks) for participants positive on imaging, and every 12 months (+/- 2 months) for participants negative on imaging until 5 years.
• Evaluate PSA doubling in association with 18F-DCFPyL changes [ Time Frame: baseline through 5 years ]
  PSA test every 3 months (+/- 2 weeks) until 5 years.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Primary clinical

Condition

• Prostate Cancer
• Biochemically Recurrent

Intervention

Drug: 18F-DCFpyL

Administered to Cohort.

Study Groups/Cohorts

Cohort 1

Participants with biochemically recurrent prostate cancer

Intervention: Drug: 18F-DCFpyL

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 13, 2024): 350
• Original Estimated Enrollment (submitted: October 19, 2022): 250
• Estimated Study Completion Date: December 31, 2025
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Amy R Hankin, P.A.-C; (240) 858-3149; amy.hankin@nih.gov

Contact: Ravi A Madan, M.D.; (301) 480-7168; rm480i@nih.gov

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05588128
• Other Study ID Numbers: 10000628; 000628-C
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: .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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: Clinical data will be made available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Clinical data will be made available upon request and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.

• Current Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
• Original Responsible Party: Same as current
• Current Study Sponsor: National Cancer Institute (NCI)
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ravi A Madan, M.D.; National Cancer Institute (NCI)

• PRS Account: National Institutes of Health Clinical Center (CC)
• Verification Date: March 12, 2024