Using 18F-DCFPyL Imaging to Check Treatment Response to Radiation Therapy in Prostate Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05155046

Provider View

This study is exploring whether a special imaging agent, 18F-DCFPyL, can help doctors see how well prostate cancer treatments are working. It focuses on patients with newly diagnosed prostate cancer who are receiving radiation therapy, with or without hormone therapy.

Patient Parameters

Program Overview

The study aims to find out if an imaging agent called 18F-DCFPyL can help detect how well prostate cancer responds to treatment. This agent is used during PET scans to provide detailed images of the cancer. The study involves patients aged 18 and older who have been newly diagnosed with prostate cancer and are planning to receive stereotactic body radiation therapy (SBRT), with or without hormone therapy (androgen deprivation therapy or ADT).

Description

This study is investigating how well a special imaging agent, 18F-DCFPyL, can detect prostate cancer's response to treatment. Prostate cancer can be challenging to identify early, especially in medium- and high-risk cases. This study uses PET scans with 18F-DCFPyL to see if it can help.

Participants will undergo several tests, including medical history review, physical exams, blood tests, and MRI scans. They will have baseline MRI and PET/CT scans, where they will receive an injection of 18F-DCFPyL. These scans will be repeated at different times during the study.

Participants will receive stereotactic body radiation therapy (SBRT) with or without hormone therapy (ADT). They will also complete questionnaires about their quality of life and report any symptoms or medications they are using. Blood and urine samples will be collected, and a tumor sample from a previous biopsy will be used.

After treatment, follow-up visits will occur 1 month after treatment, then every 3 months for a year, and every 6 months for another year. The study aims to see if 18F-DCFPyL can help identify cancer recurrence or persistence early, potentially allowing for more effective treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with localized prostate cancer and planning to receive stereotactic body radiation therapy (SBRT) with or without hormone therapy (ADT).
  • Must have at least one site of prostate cancer confirmed by MRI and biopsy.
  • Aged 18 years or older.
  • ECOG performance status of 0 to 2, indicating good overall health.
  • If HIV positive, must be on effective treatment with undetectable viral load.
  • If hepatitis B positive, must have undetectable viral load on treatment.
  • If hepatitis C positive, must have been treated and cured, or have undetectable viral load if currently on treatment.
  • Must understand and agree to sign informed consent.
  • Men must agree to use effective contraception during the study and for 2 months after the last scan.

Exclusion Criteria

  • Have received prior hormone therapy, radiation, or surgery for prostate cancer.
  • Have any condition that might interfere with the study.
  • Plan to receive pelvic nodal irradiation.
  • Have high serum creatinine levels (more than twice the normal limit).
  • Weigh more than 350 lbs or cannot fit in the imaging machine.
  • Have evidence of cancer spread beyond the prostate.
  • Have contraindications to radiation or SBRT.

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