Clinical trial NCT06494696: 68Ga-PSMA PET/MRI in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk
Official title: Utilizing 68Ga-PSMA PET/MRI Imaging in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: Ga-68 PSMA PET/MRI
PI-RADS
Biopsy naive
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council
First posted: 2024-07-10
Enrollment: 71
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: PPV of concordant PET/MRI lesion plus PI-RADS score 4~5
timeFrame: 2 years after PSMA PET/MRI scan
measure: NPV of using negative PET lesion plus PI-RADS score 1~3
timeFrame: 2 years after PSMA PET/MRI scan
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital ,Linkou
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Jing-Ren Tseng, MD
role: PRINCIPAL_INVESTIGATOR
References:
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