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NCT Number: NCT06494696

68Ga-PSMA PET/MRI 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–85 year

Sex eligibility

Male

Study type

Observational

Primary location

Chang Gung Memorial Hospital ,Linkou

Taoyuan City, 333, Taiwan

Location status: Recruiting

Location contact

Jing-Ren Tseng, MD

CONTACT

[email protected]

09753-61314

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Males aged between 40 and 85 years with a life expectancy greater than two years.
  • Naïve to prostate biopsy in the past.
  • Assessment of daily physical status graded 0 to 2 based on the Eastern Cooperative Oncology Group (ECOG) criteria.
  • Willing to sign the informed consent.

Exclusion criteria

  • 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.
  • With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast.
  • High risk to conduct examination after evaluations of PI
  • Patient had previous malignancy history

Treatment and study plan

Ga-68 PSMA PET/MRI

Diagnostic Test

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.

Primary outcomes

  1. 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. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jing-Ren Tseng, MD

CONTACT

[email protected]

+886-975361314

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • National Science and Technology Council

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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