68Ga-PSMA-11 PET versus mpMRI for diagnosing prostate cancer
68Ga-PSMA-11 PET Imaging in the Diagnostic Study of Newly Diagnosed, Untreated Prostate Cancer, With a Head-to-head Comparison to mpMRI
This test will see if 68Ga-PSMA-11 PET scans (PET/CT or PET/MRI) find prostate cancer more accurately than multiparametric MRI in men with newly diagnosed, untreated prostate cancer.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT07209878 on ClinicalTrials.gov |
What this trial studies
Men with biopsy-confirmed, treatment-naive prostate adenocarcinoma undergo 68Ga-PSMA-11 PET imaging (PET/CT or PET/MRI) and multiparametric MRI before planned radical prostatectomy. Imaging results from PSMA PET and mpMRI are compared head-to-head, with surgical histopathology serving as the reference standard. The study is performed at a single center and enrolls patients who will have prostatectomy within 28 days of imaging. Diagnostic performance metrics such as lesion detection, localization, and accuracy are analyzed to compare the two imaging approaches.
Who should consider this trial
Good fit: Ideal candidates are men with biopsy-confirmed prostate adenocarcinoma who have not received anti-tumor treatment and are scheduled for radical prostatectomy within 28 days of imaging.
Not a fit: Patients who have already received prostate cancer treatment, have other active malignancies, or cannot complete the required imaging or planned surgery are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could improve detection and localization of prostate cancer before surgery, helping guide treatment decisions and surgical planning.
How similar studies have performed: Prior clinical trials have shown 68Ga-PSMA-11 PET is useful in prostate cancer imaging, but direct head-to-head comparisons with mpMRI remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Biopsy-confirmed adenocarcinoma of the prostate. * No anti-tumor treatment received prior to the PET imaging. * Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements. * Radical prostatectomy scheduled within 28 days after PET imaging Exclusion Criteria: * Patients with other malignant tumors * Subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.
Where this trial is running
Fuzhou, Fujian
- Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Weibign Miao, MD — First Affiliated Hospital of Fujian Medical University
- Study coordinator: Weibing Miao, MD
- Email: miaoweibing@126.com
- Phone: 86-0591-87981618
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.