Using 18F-DCFPyL Imaging to Evaluate Prostate Cancer Treatment Response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the effectiveness of the imaging agent 18F-DCFPyL in detecting treatment responses in patients with localized prostate cancer undergoing stereotactic body radiation therapy (SBRT) with or without androgen deprivation therapy (ADT). Participants will undergo baseline MRI and PET/CT scans after receiving the radiotracer, allowing researchers to evaluate how well the imaging agent identifies disease persistence or recurrence. The study focuses on improving early detection of treatment outcomes to potentially enable timely salvage therapies for patients at risk of recurrence.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Deborah E Citrin, M.D. — National Cancer Institute (NCI)
• Study coordinator: Debbie-Ann N Nathan, R.N.
• Email: dnathan@mail.nih.gov
• Phone: (240) 858-3103

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.