Using Ga-68 PSMA PET/MRI to Improve Prostate Cancer Diagnosis
Utilizing 68Ga-PSMA PET/MRI Imaging in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk
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 type | Observational |
|---|---|
| Enrollment | 71 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | Male |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Locations | 1 site (Taoyuan City) |
| Trial ID | NCT06494696 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promising results with similar imaging approaches, suggesting potential for success in this novel application.
Eligibility criteria
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 this trial is running
Taoyuan City
- Chang Gung Memorial Hospital ,Linkou — Taoyuan City, Taiwan (Recruiting)
Study contacts
- Principal investigator: Jing-Ren Tseng, MD — Chang Gung Memorial Hospital
- Study coordinator: Jing-Ren Tseng, MD
- Email: drTsengJR@gmail.com
- Phone: +886-975361314
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.