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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 120 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years
  • Procedures mentioned: PET scans, Blood draws, MRI scans, CT scans, Physical exams, Injections, Questionnaires, Urine samples, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Researchers want to see if a radiotracer used during PET scans can help."
  • "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 hour (+/- 15 minutes) later, they will get the PET/CT scan."
  • "Participants will complete questionnaires about their quality of life."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether an imaging agent called 18F-DCFPyL can help PET scans show how prostate cancer responds to treatment. It is for adults with newly diagnosed prostate cancer that has not spread to distant parts of the body who plan to get focused radiation treatment called SBRT, with or without hormone treatment.

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 hour (+/- 15 minutes) 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have prostate cancer confirmed by a biopsy (a tissue sample), with at least one cancer site seen on MRI and confirmed by biopsy.
  • Plan to get SBRT to treat the cancer, with or without hormone treatment before radiation.
  • Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • If you have HIV, be on effective treatment with no virus detected in blood within the past 6 months.
  • If you have hepatitis B, have no virus detected in blood, using treatment if needed. If you have hepatitis C, it must be cured or under treatment with no virus detected in blood.
  • Be able to understand the study and willing to sign a consent form.
  • Agree to use birth control with your partner or not have sex during the study and for 2 months after the last 18F-DCFPyL scan.

Who can't join

  • Have had hormone treatment, radiation, or surgery for prostate cancer.
  • Have a health condition that could affect study tests or results.
  • Plan to have radiation to lymph nodes in the pelvis.
  • Have a blood creatinine level more than twice the highest normal level. This test checks kidney function.
  • Weigh more than 350 pounds or be unable to fit in the scanner.
  • Have cancer that has spread beyond the prostate or seminal vesicles (glands next to the prostate), including to lymph nodes or other body parts.
  • Have a condition that makes radiation or SBRT unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

MD

  • National Institutes of Health Clinical Center · Bethesda, MD 20892For more information at the NIH Clinical Center contact National Cancer Institute Referral Office · Study contact · 888-624-1937More trials in Bethesda