PSMA-based PET Imaging for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new imaging agent called 18F-DCFPyL to determine if it can better detect prostate cancer in the prostate gland and other areas like bones and lymph nodes. The goal is to enhance how doctors identify and assess prostate cancer before surgery. Men recently diagnosed with prostate cancer, particularly those with a high Gleason score (a measure of cancer aggressiveness), and planning to undergo radiation therapy and hormone treatment might be eligible. As an Early Phase 1 trial, this research focuses on understanding how the imaging agent works in people, offering participants the chance to be among the first to benefit from this innovative approach.
What prior data suggests that this imaging technique is safe for prostate cancer detection?
Research has shown that 18F-DCFPyL is safe to use. Studies have found it to be an effective tool for detecting prostate cancer, with no major safety issues reported. This imaging method has received approval for identifying prostate cancer that has recurred or spread, indicating it meets safety standards for these uses. Patients generally tolerate it well. Overall, evidence suggests this method is safe for imaging prostate cancer.12345
Why are researchers excited about this trial?
Researchers are excited about 18F-DCFPyL because it offers a new approach to imaging prostate cancer. Unlike traditional imaging methods like CT or MRI scans that rely on anatomical changes, 18F-DCFPyL is a radiotracer that targets the prostate-specific membrane antigen (PSMA), a protein highly expressed in prostate cancer cells. This allows for more precise detection and localization of cancerous tissues, potentially leading to improved diagnosis and monitoring of prostate cancer. By providing clearer images of cancer spread, this method might help tailor treatments more effectively, making it a promising tool in managing prostate cancer.
What evidence suggests that this imaging technique is effective for detecting prostate cancer?
Research has shown that 18F-DCFPyL, which participants in this trial will receive, is a useful tool for detecting prostate cancer. Studies have demonstrated that this substance accurately identifies cancer when present and minimizes false positives. 18F-DCFPyL targets a protein called PSMA, found on prostate cancer cells, and binds to it strongly. This aids in locating cancer in the prostate gland and other areas like bones or lymph nodes. Its strong predictive ability makes it a promising method for diagnosing cancer without surgery. Overall, early findings suggest that 18F-DCFPyL could significantly enhance the detection and monitoring of prostate cancer.24678
Who Is on the Research Team?
Curtiland Deville, M.D.
Principal Investigator
The SKCCC at Johns Hopkins
Are You a Good Fit for This Trial?
This trial is for men over 18 with newly diagnosed prostate cancer, graded Gleason 8-10, who are planning to have radiation and ADT. They must be medically fit for these treatments and at least 10 days post-prostate biopsy. Men already on hormone therapy or those who've had chemotherapy, investigational therapies, or prior pelvic radiation can't participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Imaging
Participants undergo baseline DCFPyL PET-MRI fusion or PET/MRI imaging
Treatment
Participants receive 2-3 months of androgen deprivation therapy (ADT) with follow-up imaging
Follow-up Imaging
Participants undergo follow-up DCFPyL PET-MRI fusion or PET/MRI imaging to assess response to ADT
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 18F-DCFPyL
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
National Cancer Institute (NCI)
Collaborator