Molecular PET/MR Imaging in Vivo Validation of Biomarker for Human Prostate Cancer (PCAPETMR)

Primary objective:

To correlate the blood/urine metabolomic biomarkers with PET/MR imaging.

Secondary objectives:

1. To evaluate the sensitivity and specificity of the PET/MR in diagnosis of prostate cancer.
2. To examine the diagnostic performance among subgroups of defined high-risk and low-risk subjects.
3. To interrogate the metabolomic alterations with the molecular PET/MR to develop workable panel biomarkers.

Study Overview

• Status: Unknown
• Conditions: Prostate Adenocarcinoma

Detailed Description

According to 2015 National Comprehensive Cancer Network (NCCN) guideline, medical imaging plays important roles for detection and staging for PCa, in addition to blood or urine biomarkers. Although there are a number of very different diagnostic imaging methods, e.g. transrectal ultrasound (TRUS), computed tomography (CT), magnetic resonance (MR) imaging and spectroscopy, or 18F-FDG positron emission tomography (PET), none of these have gained a dominant role as the optimum method for all clinical scenarios.The recently added armamentarium, PET/MR, might improve diagnosis in this regard.

Therefore, we conduct this trial to identify the ability of [11C]Choline PET/MR to evaluate the patients with prostate cancer, especially under the circumstance of elevated PSA level.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan
    • Guishan, Taoyuan, Taiwan, 333
      • Recruiting
      • Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital
      • Contact: Gigin Lin, MD, PhD; Phone Number: 2575 886-3281200; Email: giginlin@cgmh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients in a tertiary referral center.

Description

Inclusion Criteria:

• Males
• 40-85 years of age
• Patients with a biopsy-proven or clinically highly suspected prostate adenocarcinoma, or benign prostatic hyperplasia
• Able to tolerate [11C]Choline PET scan and MRI scan
• Written informed consent from the patient

Exclusion Criteria:

• Acute prostatitis or non-urologic bacterial infection requiring medical treatment within the last 3 months.
• History of AIDS in the period prior to the screening.3

• Contraindications to [11C]Choline PET/MR scans

  1. Surgical implants including pacemaker implants, cochlear implants, dentures held in place by magnets imbedded in the gums and aneurysm clips except those inserted at CGMH
  2. Metallic prosthesis of the hip or pelvic region
  3. Renal function impairment with estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2
  4. Claustrophobia
  5. Medical drugs with choline
  6. Previous allergy to carbon-labeled radionuclide
• Active other malignancy within the last 2 years
• Subject which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety.
• Prisoners or patients with mental illness

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
prostate cancer; The newly diagnostic number for the high-risk PCa patients in our hospital annually is ~70, it is clinically feasible to recruit 40 patients a year since the study begins. The study could be completed in 3 years with 120 cases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Accuracy	sensitivity, specificity, accuracy	1 year

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Gigin Lin, MD, PhD, Medical Imaging and Intervention, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ANTICIPATED): December 31, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (ACTUAL): March 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 8, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: MRI; PET; prostate cancer; metabolomics; molecular imaging; 11C-choline tracer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 105-6435C; 104-4855A (OTHER: CGMH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No