18F-DCFPyL Imaging as a Method to Assess Treatment Response to Stereotactic Body Radiation Therapy

NCT05155046 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 10000481000481-C
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Identifying medium- and high-risk prostate cancer early may allow for treatments to work. But identification can be hard. Researchers want to see if a radiotracer used during PET scans can help. Objective: To test how an imaging agent called 18F-DCFPyL detects response to standard prostate cancer treatment. Eligibility: People ages 18 and older with newly diagnosed prostate cancer who have no evidence of distant metastatic disease and plan to get stereotactic body radiation therapy (SBRT) with or without androgen deprivation therapy (ADT). Design: Participants will be screened with: Medical history Physical exam Blood tests MRI Participants will have baseline MRI and PET/CT scans. For the MRI, they may get a contrast agent by IV injection. For the PET/CT scan, they will get an IV injection of 18FDCFPyL. About 1 to 2 hours later, they will get the PET/CT scan. During the scans, participants will lie on their back and remain still for 45 minutes to 1 hour. These scans will be repeated at different points during the study. Participants will get SBRT with or without ADT. Participants will complete questionnaires about their quality of life. Participants will be asked about any symptoms they are having. They will also be asked about medications they are using. They may have a physical exam. Participants will give blood and urine samples. They will give a tumor sample from a biopsy they have had in the past. After treatment, participants will have follow-up visits. These will occur 1 month after treatment, then every 3 months for a year, and then every 6 months for 1 more year.

Conditions

Localized Prostate Cancer

Keywords

Localized Prostate Cancer; Radiotherapy; Prostate Specific Membrane Antigen; Androgen Deprivation Therapy; longitudinal quality of life

Outcome Measures

Primary Outcomes (1)

• Imaging response to treatment

  For the purpose of this study, the imaging response to treatment will be categorized separately in the radiation treatment volume (in field; local) and distantly (outside the radiation treatment volume). In-field (in the radiation target volume) 18F-DCFPyL PET/CT treatment response in field will be evaluated using a descriptor (complete, partial, progression) based on maximum SUV and volume of uptake relative to the pre-treatment imaging. Presence of new areas of uptake suspicious for prostate cancer outside of the region of radiation treatment will be considered progression but will be scored separately and will not impact the assessment of response from radiation locally.

  Baseline, 8 weeks after ADT initiation (if applicable), 6 months post SBRT, at recurrence

Study Arms (1)

18F-DCFPyL imaging

EXPERIMENTAL

18F-DCFPyL imaging with routine imaging (mpMRI)

Drug: 18F-DCFPyL

Interventions

18F-DCFPyL DRUG

18F-DCFPyL imaging will be performed at baseline, 8 weeks after ADT initiation, 6 months post SBRT and at recurrence. The target administered activity will be 6.5 mCi with a lower limit of 6 mCi.

18F-DCFPyL imaging

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven localized prostate cancer in whom stereotactic body radiation treatment (SBRT) with or without neoadjuvant androgen deprivation therapy (ADT) is planned for definitive management (NIH laboratory of pathology confirmation is not required).
• Must have at least 1 MRI detected, biopsy proven localized prostate cancer.
• Age \>= 18 years
• ECOG performance status \<= 2
• For individuals with evidence of human immunodeficiency virus (HIV) infection, individuals must be on effective anti-retroviral therapy with undetectable viral load within the prior 6 months are eligible.
• For individuals with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
• For individuals with a history of hepatitis C virus (HCV), the infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• Ability of subject to understand and the willingness to sign a written informed consent document.
• Men must agree to use adequate contraception with their partner (hormonal or barrier method of birth control; abstinence) for the duration of study participation and 2 months after the last 18F-DCFPyL scan.

You may not qualify if:

• Receiving prior androgen deprivation therapy, radiotherapy, or surgery for prostate cancer.
• Any condition that is likely to interfere with study procedures or results.
• Individuals in whom pelvic nodal irradiation is planned.
• Serum creatinine \> 2 times the upper limit of normal.
• Weighing \> 350 lbs (weight limit for scanner table), or unable to fit in imaging gantry.
• Evidence of tumor spread beyond the prostate/seminal vesicles (lymph nodes, metastases).
• Contraindications to radiation or SBRT.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid

Study Officials

• Deborah E Citrin, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Debbie-Ann N Nathan, R.N.

CONTACT

(301) 451-8968; dnathan@mail.nih.gov

Deborah E Citrin, M.D.

CONTACT

(240) 760-6206; citrind@mail.nih.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 13, 2021
• Study Start: August 31, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04-13

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data 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 via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.

Locations

US (1)