68Ga-PSMA PET/MRI in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk

July 2, 2024 updated by: Chang Gung Memorial Hospital

Utilizing 68Ga-PSMA PET/MRI Imaging in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk

The goal of this observational study is to learn if Ga-68 PSMA PET/MRI can better diagnose prostate cancer than mpMRI in males between 40 to 85 years old who is naive to prostate biopsy and is suspicious for prostate cancer by elevated PSA or lower urinary tract symptoms. The main questions it aims to answer are:

  1. Does PSMA PET/MRI have better PPV and NPV than mpMRI to diagnose prostate cancer?
  2. Does lesion location concordance in PSMA PET and MRI effect diagnosis accuracy?

Participants will:

  1. Undergo a Ga-68 PSMA PET/MRI scan and keep followed up for 2 years to check if prostate cancer is diagnosed after the scan.
  2. Between the follow-up period, visit the clinic once every 6 months for checkups and blood tests.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taoyuan City, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital ,Linkou
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who indicated MRI of pelvis due to clinical suspicion of prostate cancer based on elevated PSA (4~20 ng/mL), abnormal digital rectal examination or lower urinary tract syndromes.

Description

Inclusion Criteria:

  1. Patients who indicated MRI of pelvis due to clinical suspicion of prostate cancer based on elevated PSA (4~20 ng/mL), abnormal digital rectal examination or lower urinary tract syndromes.
  2. Males aged between 40 and 85 years with a life expectancy greater than two years.
  3. Naïve to prostate biopsy in the past.
  4. Assessment of daily physical status graded 0 to 2 based on the Eastern Cooperative Oncology Group (ECOG) criteria.
  5. Willing to sign the informed consent.

Exclusion Criteria:

  1. Unable to tolerate the PET/MRI scan, such as those with claustrophobia, unable to lie still, consciousness unclear, vital sign unstable, or having MRI unsafe metallic implants or devices.
  2. With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast.
  3. High risk to conduct examination after evaluations of PI
  4. Patient had previous malignancy history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental
Diagnostic test: Ga-68 PSMA PET/MRI
The participant will undergo a Ga-68 PSMA PET/MRI scan, and then be followed up for 2 years to see if prostate cancer is diagnosed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPV of concordant PET/MRI lesion plus PI-RADS score 4~5
Time Frame: 2 years after PSMA PET/MRI scan
Comparing positive predictive values (PPV) of using concordant PET/MRI lesion plus PI-RADS score 4~5 as positive test with PPV of using PI-RADS 4~5 alone as positive test to predict diagnosing prostate cancer within 2 years.
2 years after PSMA PET/MRI scan
NPV of using negative PET lesion plus PI-RADS score 1~3
Time Frame: 2 years after PSMA PET/MRI scan
Comparing negative predictive values (NPV) of using negative PET lesion plus PI-RADS score 1~3 as negative test with NPV of using PI-RADS 1~3 alone as negative test to predict diagnosing prostate cancer within 2 years.
2 years after PSMA PET/MRI scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

National Science and Technology Council

Investigators

  • Principal Investigator: Jing-Ren Tseng, MD, Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

July 2, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202400643A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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