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Clinical trial Recruiting at 1 site Observational Ages 40 to 85 Men only

Using Ga-68 PSMA PET/MRI to Improve Prostate Cancer Diagnosis

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

Run by Chang Gung Memorial Hospital · NCT06494696 · Data updated 2026-11-12

This study is testing if a new type of scan called Ga-68 PSMA PET/MRI can help men aged 40 to 85 get a more accurate diagnosis of prostate cancer compared to the standard MRI.

Quick facts

Study typeObservational
Ages40 Years to 85 Years
SexMen only
Enrollment71 (estimated)
SponsorChang Gung Memorial Hospital
Academic / other
Locations1 site (Taoyuan City)
StatusRecruiting
StartedJuly 1, 2024
Main results expectedMay 31, 2027
Study endsMay 31, 2027
Registry record updatedJuly 10, 2024
Trial IDNCT06494696 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are males aged 40 to 85 with elevated PSA levels or lower urinary tract symptoms who have never undergone a prostate biopsy.

Probably not a fit

Patients who have previously been diagnosed with malignancies or those unable to tolerate the PET/MRI scan will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to determine if Ga-68 PSMA PET/MRI can provide better diagnostic accuracy for prostate cancer compared to mpMRI in men aged 40 to 85 who are suspected of having prostate cancer. Participants will undergo a Ga-68 PSMA PET/MRI scan and will be followed for two years to monitor for prostate cancer diagnosis. The study will evaluate the positive predictive value (PPV) and negative predictive value (NPV) of PSMA PET/MRI and assess the impact of lesion location concordance on diagnostic accuracy. Regular follow-up visits will occur every six months for checkups and blood tests.

Why it matters

Potential benefit: If successful, this study could lead to more accurate prostate cancer diagnoses, potentially improving patient outcomes.

How similar studies have gone: Other studies have shown promising results with similar imaging approaches, suggesting potential for success in this novel application.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Chang Gung Memorial Hospital ,Linkou
    Taoyuan City, Taiwan     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.