Phase 2
Completed N=18
11C- and 18F-Choline PET/MR Imaging for Prostate Cancer
Source: ClinicalTrials.gov NCT02397408 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Mean Kinetic Parameters Reflecting Fluorocholine (FCH) Fluorine 18 FCH (F-18) Influx (K1) — 0.562 K1 (min-1)
Summary
This phase II trial studies how well 11C-choline (carbon C 11 choline) and 18F-choline (fluorine F 18 choline) positron emission tomography/magnetic resonance (PET/MR) imaging works in diagnosing patients with unfavorable intermediate to high-risk prostate cancer. Diagnostic procedures, such as 11C- and 18F-choline PET/MR may help find and diagnose prostate cancer and find out how far the disease has spread.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Kinetic Parameters Reflecting Fluorocholine (FCH) Fluorine 18 FCH (F-18) Influx (K1) |
0.562 | — |
| PRIMARY Mean Maximum Kinetic Parameters Reflecting F-18 Influx (K1max) |
0.753 | — |
| PRIMARY Average Standardized Uptake Value (SUVavg) |
6.10 | — |
| PRIMARY Mean of the Standardized Uptake Value (SUVmax) |
8.40 | — |
| PRIMARY Sensitivity of Combined Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging |
88 | — |
| PRIMARY Specificity of of Combined Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging |
100 | — |
| PRIMARY Correlation of K1 of Primary Tumors With K1max |
0.86 | — |
| PRIMARY Correlation of K1 of Primary Tumors With Average Standardized Uptake Value (SUVavg) |
0.76 | — |
| PRIMARY Correlation of K1max of Primary Tumors With SUVmax |
0.65 | — |
| PRIMARY Correlation of K1max of Primary Tumors With SUVavg |
0.60 | — |
| PRIMARY Correlation of SUVmax of Primary Tumors With SUVavg |
0.65 | — |
| SECONDARY Correlation of SUVmax of Primary Tumors With Serum Prostate-specific Antigen (PSA) Level |
0.71 | — |
| SECONDARY Correlation of SUVmax of Primary Tumors With Pathological Stage |
0.59 | — |
| SECONDARY Correlation of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Scores |
0.72 | — |
| SECONDARY Comparison of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Score Groups |
9.53; 6.24 | <.008 sig |
Eligibility Criteria
Inclusion Criteria
- Age: Patients must be >=18 years of age
- Diagnosis: Patients must have a diagnosis of prostate cancer by histologic verification and a hypoechoic lesion seen on ultrasound.
- Disease Status: Unfavorable intermediate to high-risk prostate cancer, per the Cancer of the Prostate Risk Assessment Score (CAPRA) (CAPRA 5-10)
- Karnofsky Performance Status >=70
- Metastatic workup: Whole Body Sodium Fluoride (NaF) PET/CT or 99mTc Bone Scan
- Planned to undergo radical prostatectomy and extended pelvic lymph node dissection
- Adequate bone marrow and organ function defined as follows:
- Adequate bone marrow function:
- Leukocytes >= 3,000/microliter (mcL)
- Absolute Neutrophil Count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Adequate hepatic function:
- Total bilirubin - within normal institutional limits
- Aspartate aminotransferase (AST)/ serum glutamic-oxaloacetic transaminase (SGOT) = 60 mL/min/ 1.73m2 for patients with creatinine levels above institutional normal
- Ability to understand a written informed consent document, and the willingness to sign it
Exclusion Criteria
- Participation would significantly delay the scheduled standard of care therapy
- Karnofsky performance status of < 60
- Inadequate venous access
- Administered a radioisotope within 5 physical half lives prior to study enrollment
- Have a medical condition or other circumstances which, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the study.
Data sourced from ClinicalTrials.gov (NCT02397408). 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.