RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-08-31
Study Completion:2029-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05155046

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  2. * Must have at least 1 MRI detected, biopsy proven localized prostate cancer.
  3. * Age \>= 18 years
  4. * ECOG performance status \<= 2
  5. * 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.
  6. * For individuals with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  7. * 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.
  8. * Ability of subject to understand and the willingness to sign a written informed consent document.
  9. * 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.
  1. * Receiving prior androgen deprivation therapy, radiotherapy, or surgery for prostate cancer.
  2. * Any condition that is likely to interfere with study procedures or results.
  3. * Individuals in whom pelvic nodal irradiation is planned.
  4. * Serum creatinine \> 2 times the upper limit of normal.
  5. * Weighing \> 350 lbs (weight limit for scanner table), or unable to fit in imaging gantry.
  6. * Evidence of tumor spread beyond the prostate/seminal vesicles (lymph nodes, metastases).
  7. * Contraindications to radiation or SBRT.

Contacts and Locations

Study Contact

Debbie Nathan, R.N.
CONTACT
(301) 451-8968
dnathan@mail.nih.gov
Deborah E Citrin, M.D.
CONTACT
(240) 760-6206
citrind@mail.nih.gov

Principal Investigator

Deborah E Citrin, M.D.
PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Deborah E Citrin, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-31
Study Completion Date2029-12-31

Study Record Updates

Study Start Date2022-08-31
Study Completion Date2029-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Localized Prostate Cancer