PSMA PET initial staging to predict outcomes in newly diagnosed prostate cancer
Official title: A Multicenter, Prospective Study on the Prognostic Value of PSMA PET in Patients With Newly Diagnosed, Treatment-naïve Prostate Cancer
Run by Xijing Hospital · NCT07474142 · Data updated 2026-11-12
We will test whether PSMA PET scans done before any treatment can predict how long people with newly diagnosed prostate cancer stay free from disease progression.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | Men only |
| Enrollment | 1000 (estimated) |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 9 sites (Lanzhou, Gansu and 8 other locations) |
| Status | Recruiting |
| Started | March 3, 2026 |
| Main results expected | March 3, 2028 |
| Study ends | March 3, 2036 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT07474142 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with biopsy‑confirmed, newly diagnosed prostate cancer who had a PSMA PET scan before any treatment and can provide at least two years of follow‑up data.
✕Probably not a fit
Patients who have already received prostate cancer treatment, those with neuroendocrine prostate cancer or other non‑prostate metastatic malignancies, and people without baseline PSMA PET scans are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, multicenter observational study will enroll patients with biopsy‑confirmed, treatment‑naïve prostate cancer who undergo PSMA PET as initial staging. Imaging and clinical data will be combined to develop a PSMA‑VISION score aimed at predicting progression‑free survival with at least two years of follow‑up. The new score will be compared directly with existing prognostic tools (NCCN, STARCAP, PPP and PPP2 nomograms) to measure relative performance. Participating centers include Xijing Hospital and collaborating hospitals across several Chinese provinces.
Why it matters
Potential benefit: If successful, the PSMA‑VISION score could help personalize initial treatment decisions by identifying patients at higher or lower risk of progression.
How similar studies have gone: Large international studies using PROMISE‑based PPP nomograms have shown strong prognostic performance (C‑indices ~0.77–0.80) across mixed disease stages, but focused data on treatment‑naïve, newly diagnosed cohorts are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 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.
Where it's running
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The First Hospital of Lanzhou University
Lanzhou, Gansu, China Recruiting -
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China Recruiting -
Qinghai University Affiliated Hospital
Xining, Qinghai, China Recruiting -
Weinan Central Hospital
Weinan, Shaanxi, China Recruiting -
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China Recruiting -
Xijing 986 Hospital
Xi'an, Shaanxi, China Recruiting
Show 3 more locations
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Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China Recruiting -
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi, China Recruiting -
Affiliated Hospital of Yan'an University
Yan’an, Shaanxi, China Recruiting
Study contacts
- Study coordinator: Jianhua Jiao, MD.
- Email: 1531769428@qq.com
- Phone: +86 18700919857
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.