Using 18F-Fluciclovine PET/CT to Predict Outcomes of Prostate Cancer Therapy
Usefulness of Tumor Heterogeneity Assessment in Patients With MCRPC Undergoing Radioligand Therapy With 177LU-PSMA-617 Using Serial 18F-DCFPYL, 18F-FDG and 18F-Fluciclovine PET/CT Predicting Clinical Outcome
This study is testing if special imaging can help predict how well a new prostate cancer treatment works for patients with advanced disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | VA Greater Los Angeles Healthcare System Federal |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06706921 on ClinicalTrials.gov |
What this trial studies
This is a single-center, prospective study focusing on patients with metastatic castration-resistant prostate cancer (mCRPC) who are scheduled to receive Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT). Participants will undergo baseline imaging with 18F-Fluciclovine PET/CT and will have follow-up scans after the 2nd, 4th, and 6th cycles of LuPSMA RLT. The study aims to analyze the imaging data to correlate PET metrics with clinical outcomes, providing insights into the effectiveness of the therapy. The goal is to assess how well these imaging techniques can predict patient responses to treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adult males diagnosed with metastatic castration-resistant prostate cancer who are scheduled to receive LuPSMA RLT.
Not a fit: Patients under 18 years old or those with serious concurrent illnesses that may interfere with study procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict clinical outcomes for patients undergoing prostate cancer therapy, leading to more personalized treatment plans.
How similar studies have performed: Other studies have shown promise in using PET imaging to assess treatment responses in prostate cancer, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with mCRPC scheduled to undergo LuPSMA RLT. * Willingness to undergo multiple serial PET/CT scans pre- and post-LuPSMA RLT. * Ability of providing written informed consent. Exclusion Criteria: * Less than 18 years-old at the time of radiopharmaceutical administration. * Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance. * Contraindications to LuPSMA RLT.
Where this trial is running
Los Angeles, California
- VA Greater Los Angeles Healthcare System — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: Gholam Berenji, MD
- Email: Gholam.Berenji@va.gov
- Phone: 310-268-3547
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.