The Role of C-11 Choline PET in Patients With Prostate Cancer

NCT02852122 | Completed DMC

• 1 other identifier: 102-3271A
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Latent Cancer Prostate

Keywords

prostate cancer; C11 Choline PET/MR; staging; biochemical failure

Outcome Measures

Primary Outcomes (1)

• The Role of C-11 Choline PET in Patients with Prostate Cancer

  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.

  Two years

Study Arms (1)

C-11 choline

EXPERIMENTAL

Drug: C-11 choline

Interventions

C-11 choline DRUG

This is an uncontrolled, open-labeled, non-randomized, prospective study. The study duration is expected to be completed in a period of 2 years. Up to 54 patients with primary prostate cancer and stratified as high risk group (PSA \> 20 ng/mL, or Gleason score 8-10, or clinical stage \>T2c) would be included.

C-11 choline

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Age equals or more than 20 years old
• Willing to sign the informed consent

You may not qualify if:

• Patients with a concomitant or previous malignancy history
• 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
• Unable to give informed consent
• Previous allergy to carbon-labelled radionuclide

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: August 2, 2016
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 4, 2017

Record last verified: 2017-01