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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05155046
Recruitment Status : Recruiting
First Posted : December 13, 2021
Last Update Posted : January 25, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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.


Condition or disease Intervention/treatment Phase
Localized Prostate Cancer Drug: 18F-DCFPyL Phase 2

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of 18F-DCFPyL Imaging as a Method to Assess Treatment Response to Stereotactic Body Radiation Therapy
Actual Study Start Date : August 31, 2022
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 18F-DCFPyL imaging
18F-DCFPyL imaging with routine imaging (mpMRI)
Drug: 18F-DCFPyL
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.




Primary Outcome Measures :
  1. Imaging response to treatment [ Time Frame: Baseline, 8 weeks after ADT initiation (if applicable), 6 months post SBRT, at recurrence ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • 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.

EXCLUSION CRITERIA:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05155046


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

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Deborah E Citrin, M.D. National Cancer Institute (NCI)
Additional Information:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT05155046    
Other Study ID Numbers: 10000481
000481-C
First Posted: December 13, 2021    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 23, 2023
Individual Participant Data (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 data will be shared with subscribers to dbGaP.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Localized Prostate Cancer
Radiotherapy
Prostate Specific Membrane Antigen
Androgen Deprivation Therapy
longitudinal quality of life
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases