Using 68Ga-PSMA PET for diagnosing prostate cancer lymph node metastasis
Efficacy of 68Ga PSMA PET in the Diagnosis of Lymph Node Metastasis in Patients With Prostate Cancer: a Single Center Prospective Randomized Controlled Trial
This study is testing if a new type of imaging called 68Ga-PSMA PET can better detect lymph node spread in patients with newly diagnosed prostate cancer compared to the standard MRI method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | Male |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shannxi) |
| Trial ID | NCT04967001 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of 68Ga-PSMA PET/CT imaging compared to mpMRI in diagnosing lymph node metastasis in patients with newly diagnosed prostate cancer. It is a single-center, prospective, randomized controlled trial aimed at high-risk localized or locally advanced prostate cancer patients who are candidates for radical prostatectomy. The study will assess the diagnostic accuracy of these imaging modalities to improve patient outcomes in prostate cancer management.
Who should consider this trial
Good fit: Ideal candidates are high-risk localized or locally advanced prostate cancer patients with an ISUP Gleason grade group of 4 or higher.
Not a fit: Patients with prior cancers, proven distant metastases, or contraindications for MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of lymph node metastasis diagnosis in prostate cancer, leading to better treatment planning.
How similar studies have performed: Other studies have shown promising results with PSMA PET imaging in prostate cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * High risk localized/locally advanced prostate cancer patients who are candidates for radical prostatectomy plus bilateral extended PLND * ISUP Gleason grade group ≥ 4 Exclusion Criteria: * Prior history of any other cancer in the last 5 years excluding basal cell carcinoma Proven metastases in bones or other distant metastases * General contra-indications for MRI (pacemaker, aneurysm clips, any form of metal in the body, severe claustrophobia) * Serious concomitant systemic disorders that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study objectives * Metal implants in the pelvic region which will deteriorate PET/MR/CT image quality.
Where this trial is running
Xi'an, Shannxi
- Xijing Hospital — Xi'an, Shannxi, China (Recruiting)
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.