Monitoring recurrent prostate cancer with a new imaging technique
A Study of Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18F-DCFPyL
National Institutes of Health Clinical Center (CC) · NCT05588128
This study is testing a new imaging technique to see how well it can track changes in prostate cancer for men whose cancer has come back after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Drugs / interventions | radiation |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05588128 on ClinicalTrials.gov |
What this trial studies
This observational study aims to monitor men with biochemically recurrent prostate cancer using a novel radiotracer, 18F-DCFPyL, before positron emission tomography (PET) imaging. The study will track changes in cancer lesions over a five-year period to better understand the evolution of the disease in patients who have previously undergone treatment. Participants will undergo various imaging studies and blood tests to assess their condition and the effectiveness of the new imaging approach.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older who have a history of prostate cancer treatment and show rising PSA levels without evidence of metastatic disease.
Not a fit: Patients with evidence of metastatic soft tissue disease or bone lesions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the detection of recurrent prostate cancer, leading to better management and treatment options for patients.
How similar studies have performed: Other studies using advanced imaging techniques have shown promise in detecting recurrent prostate cancer, suggesting that this approach may also be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * History of primary treatment for prostate cancer (either surgery or radiation) * Serum PSA \>= 0.50 * Serum testosterone \>100 * Age \>=18 years * Men must agree to use highly effective contraception (surgical sterilization) for 7 days after every study agent administration. Note: abstinence, defined as no heterosexual sexual intercourse when this is in line with the preferred and usual lifestyle of the subject is also acceptable * The ability of a participant to understand and the willingness to sign a written informed consent document EXCLUSION CRITERIA: -Evidence of soft tissue disease on CT scan (or magnetic resonance imaging \[MRI\] as clinically indicated). NOTE: Lymph nodes \<= 1.5 cm in the shortest dimension are allowed. * Evidence of bone lesions on Tc99 bone scan * Prostatectomy within 1 year before the study intervention * Androgen deprivation therapy (ADT) within the 6 months before the study intervention * Systemic therapy for prostate cancer within the 6 months before the study intervention
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Melissa L Abel, M.D. — National Cancer Institute (NCI)
- Study coordinator: Amy R Hankin, P.A.-C
- Email: amy.hankin@nih.gov
- Phone: (240) 858-3149
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.
Conditions: Prostate Cancer, Biochemically Recurrent, Cancer Of Prostate, Natural History, Imaging