Phase 2
Completed N=17
Fluciclovine F18 PET/CT Imaging in Assessing Hormone-Naive Men With Prostate Cancer That Has Spread to the Bone
Metastatic Prostate Carcinoma · Prostate Carcinoma Metastatic in the Bone · Stage IV Prostate Cancer
Source: ClinicalTrials.gov NCT03707184 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Mean Standardized Uptake Value (SUVmean) by Lesion Type — 1.91; 2.36; 2.63; 3.05 SUV by body weight (kg)
Summary
This trial studies how well fluciclovine 18F PET/CT imaging works in assessing hormone-naive men with prostate cancer that has spread to the bone. Fluciclovine 18F is a radioactive drug used to measure tumor growth. PET/CT uses x-rays to take pictures inside the body. Comparing results of fluciclovine 18F PET/CT imaging may help doctors predict a patient's response to treatment and help plan the best treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Standardized Uptake Value (SUVmean) by Lesion Type |
1.91; 2.36; 2.63; 3.05 | — |
| PRIMARY Maximum Standardized Uptake Value (SUVmax) by Lesion Type |
4.80; 7.17; 8.39; 10.02 | — |
Eligibility Criteria
Inclusion Criteria
- Enrollment on IRB #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone).
- Patients must document their willingness to be followed for up to 24 months after recruitment by signing informed consent documenting their agreement to allow access to the data obtained on IRB #102312 and information and data entered into a research database.
- All patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines.
Exclusion Criteria
- Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator?s discretion.
- Patients who require monitored anesthesia for PET scanning.
- Patients who are too claustrophobic to undergo PET scanning.
Data sourced from ClinicalTrials.gov (NCT03707184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.