NCT07209878 68Ga-PSMA-11 PET Imaging for Diagnosing Prostate Cancer, a Head-to-head Comparison With mpMRI
| NCT ID | NCT07209878 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | First Affiliated Hospital of Fujian Medical University |
| Condition | Prostate Cancer (Adenocarcinoma) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-01-10 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2020-01-10 with a primary completion date of 2025-12-31.
⚠ 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
68Ga-PSMA-11 is a widely used radiotracer targeting PSMA. In this study, we investigated the diagnostic efficacy of 68Ga-PSMA-11 PET imaging (PET/CT or PET/MRI) in patients with newly diagnosed, treatment-naive prostate cancer, and performed a head-to-head comparison with multi-parameter magnetic resonance imaging (mpMRI).
Eligibility 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.
Contact & Investigator
Weibign Miao, MD
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Fujian Medical University
Frequently Asked Questions
Who can join the NCT07209878 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 80 Years, studying Prostate Cancer (Adenocarcinoma). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07209878 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07209878 currently recruiting?
Yes, NCT07209878 is actively recruiting participants. Contact the research team at miaoweibing@126.com for enrollment information.
Where is the NCT07209878 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT07209878 clinical trial?
NCT07209878 is sponsored by First Affiliated Hospital of Fujian Medical University. The principal investigator is Weibign Miao, MD at First Affiliated Hospital of Fujian Medical University. The trial plans to enroll 100 participants.
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