68Ga-PSMA-11 PET versus mpMRI for diagnosing prostate cancer
Official title: 68Ga-PSMA-11 PET Imaging in the Diagnostic Study of Newly Diagnosed, Untreated Prostate Cancer, With a Head-to-head Comparison to mpMRI
Run by First Affiliated Hospital of Fujian Medical University · NCT07209878 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 80 Years |
| Sex | Men only |
| Enrollment | 100 (estimated) |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Status | Recruiting |
| Started | January 10, 2020 |
| Main results expected | December 31, 2025 |
| Study ends | June 30, 2026 |
| Registry record updated | October 7, 2025 |
| Trial ID | NCT07209878 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Adaptive intraoperative biopsy system for prostate cancer using imaging and metabolic feedback
Aiming to test a smart biopsy approach that combines preoperative imaging with real-time metabolic signals to guide where to take prostate biopsy cores for better precision in men suspected of prostate cancer.
-
MRT-2359 plus apalutamide in advanced prostate cancer
This Phase 2 trial tests whether taking MRT-2359 with apalutamide can lower PSA in men with castration-resistant prostate cancer.
-
Predicting prostate cancer response to neoadjuvant darolutamide with a gene biomarker
This study tests whether a gene-based PCAI ImmunoScore can predict which high-risk localized or locally advanced prostate cancer patients will have minimal residual disease after 90–120 days of darolutamide before surgery.
-
Personal preferences for avoiding gynecomastia (Stage 1)
This project will ask men with prostate cancer and high-risk biochemical recurrence what trade-offs they'd make to avoid breast-related side effects like gynecomastia.
-
LaserSAFE: Quick in OR imaging to check margins during prostatectomy
A new in‑the‑operating‑room imaging method called LaserSAFE is tested to see if it can quickly detect cancer at the edge of the prostate during surgery for patients undergoing robot-assisted prostatectomy.
-
Early postoperative PSA after prostate removal as a predictor of cancer outcomes
We will test whether early PSA levels after prostate removal can help predict long-term cancer outcomes in men undergoing radical prostatectomy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.