NCT06494696 68Ga-PSMA PET/MRI in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk
| NCT ID | NCT06494696 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chang Gung Memorial Hospital |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 71 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 71 participants in total. It began in 2024-07-01 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Jing-Ren Tseng, MD
PRINCIPAL INVESTIGATOR
Chang Gung Memorial Hospital
Frequently Asked Questions
Who can join the NCT06494696 clinical trial?
This trial is open to male participants only, aged 40 Years or older, up to 85 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06494696 currently recruiting?
Yes, NCT06494696 is actively recruiting participants. Contact the research team at drTsengJR@gmail.com for enrollment information.
Where is the NCT06494696 trial being conducted?
This trial is being conducted at Taoyuan City, Taiwan.
Who is sponsoring the NCT06494696 clinical trial?
NCT06494696 is sponsored by Chang Gung Memorial Hospital. The principal investigator is Jing-Ren Tseng, MD at Chang Gung Memorial Hospital. The trial plans to enroll 71 participants.
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