NCT05155046 18F-DCFPyL Imaging as a Method to Assess Treatment Response to Stereotactic Body Radiation Therapy
| NCT ID | NCT05155046 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Localized Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2022-08-31 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 130 participants in total. It began in 2022-08-31 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Deborah E Citrin, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT05155046 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 120 Years, studying Localized Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05155046 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05155046 currently recruiting?
Yes, NCT05155046 is actively recruiting participants. Contact the research team at dnathan@mail.nih.gov for enrollment information.
Where is the NCT05155046 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT05155046 clinical trial?
NCT05155046 is sponsored by National Cancer Institute (NCI). The principal investigator is Deborah E Citrin, M.D. at National Cancer Institute (NCI). The trial plans to enroll 130 participants.
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