Clinical trial · Interventional
The Role of C-11 Choline PET in Patients With Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators determine the target number as 54 patients based on the following reasons: (a) The bony metastasis rate for the high risk prostate cancer patients with PSA from 20 to 99.9 ng/ml was 21% (166/767 cases in a systemic review) \[8\]; the estimated sample size would be 47 under the condition of 20% more distant metastasis cases were identified by the PET/MRI scan using the 90% power, significance level of 0.05 and one sample proportion test. Assuming a dropout rate of 10%, the final ideal sample size is 52 patients. (b) The newly diagnostic number for the high risk prostate cancer patients in our hospital annually is \~70, about 6 patients a month. It is clinically feasible to recruit 3 patients a month until 18 months since the study begin. The study could be completed in 2 years with 54 cases
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Latent Cancer Prostate | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| C-11 choline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- C-11 choline
- interventionNames
- Drug: C-11 choline
Primary outcomes (1)
- measure
- The Role of C-11 Choline PET in Patients with Prostate Cancer
- timeFrame
- Two years
- description
- Inconsistence rate (%) of C-11 Choline PET and MRI in detecting local regional and distant metastasis prostate cancer. The inconsistence rate (%) is defined as the proportion of inconsistent results by PET and MRI, i. e. PET positive but MRI negative, or PET negative but MRI positive.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Clinically suspicious and/or pathology-proved high risk group prostate cancer patients (PSA \> 20 ng/mL, or Gleason score 8-10, or clinical stage \>T2c) 2. Age equals or more than 20 years old 3. Willing to sign the informed consent Exclusion Criteria: 1. Patients with a concomitant or previous malignancy history 2. Unable to tolerate MR or PET/CT scan, such as those with magnetic implants (e.g. those received intracranial aneurysm surgery, cardiac pacemaker, artificial valves replacement, artificial ears, hip prosthesis), claustrophobia, unable to lie still 3. Unable to give informed consent 4. Previous allergy to carbon-labelled radionuclide
References
Publications (0)
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