Using 18F-DCFPyL Imaging to Evaluate Prostate Cancer Treatment Response
Phase II Trial of 18F-DCFPyL Imaging as a Method to Assess Treatment Response to Stereotactic Body Radiation Therapy
This study is testing whether a special imaging agent can help doctors see how well treatment is working for men with localized prostate cancer who are receiving radiation therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | Male |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | radiation |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05155046 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with biopsy-proven localized prostate cancer who are scheduled to receive SBRT with or without ADT.
Not a fit: Patients with distant metastatic disease or those not planning to undergo SBRT may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of treatment responses in localized prostate cancer, allowing for timely interventions.
How similar studies have performed: Similar studies using PSMA-targeted imaging agents have shown promise in detecting prostate cancer, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- 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: (301) 451-8968
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.