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NCT07474142: PSMA-VISION
A Multicenter, Prospective Study on the Prognostic Value of PSMA PET in Patients With Newly Diagnosed, Treatment-naïve Prostate Cancer
trial testing Not provided in Newly Diagnosed, Treatment-naïve Prostate Cancer in 1,000 participants. Currently enrolling.
3 March 2028
Quick facts
| Lead sponsor | Xijing Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 3 March 2026 |
| Primary completion | 3 March 2028 |
| Estimated completion | 3 March 2036 |
| Sites | 9 locations across China |
Drugs / interventions tested
- Not provided
Conditions studied
- Newly Diagnosed, Treatment-naïve Prostate Cancer — all drugs for Newly Diagnosed, Treatment-naïve Prostate Cancer →
Sponsor
Xijing Hospital
Who can join
Adults 18 to 100, male only, with Newly Diagnosed, Treatment-naïve Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Brief Summary： Under the support of the PROMISE scoring criteria, PSMA PET has demonstrated significant prognostic value. However, previous studies on PSMA PET included patients with various stages of prostate cancer, and the mixture of different disease stages may compromise the accuracy of prognostic tools. This study aims to specifically investigate the prognostic value of initial staging PSMA PET for progression-free survival in patients with newly diagnosed, treatment-naïve prostate cancer, and to develop corresponding prognostic tools. Need: The prognostic value of initial staging with PSMA PET is needed for treatment management and study design. Primary Outcome: To assess the prognostic value of initial staging by PSMA PET: generate a prognostic tool (PSMA-VISION score) based on initial staging of PSMA PET to predict progression-free survival. Secondary Outcomes: To compare PSMA-VISION score with the other prognostic tools (such as NCCN, STARCAP, PPP nomogram, PPP2 nomogram, etc.) and to evaluate the prognostic value of initial staging by PSMA PET to predict overall survival (OS). The correlation with clinicopathological variables and prediction of early progression (Exploratory) was also investigated. Inclusion: 1. Patients with pathologically confirmed prostate cancer by prostate biopsy. 2. Undergone PSMA PET examination as initial staging before any treatment. 3. Have at least 2 years of follow-up data for progression-free survival and overall survival. Exclusion Criteria: 1. Patients undergone any prior prostate cancer treatment before undergoing PSMA PET imaging. 2. Patients with metastasized or disseminated malignancy other than prostate cancer 3. Patients with neuroendocrine prostate cancer.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07474142 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xijing Hospital
- Last refreshed: 16 March 2026
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