PSMA PET initial staging to predict outcomes in newly diagnosed prostate cancer
A Multicenter, Prospective Study on the Prognostic Value of PSMA PET in Patients With Newly Diagnosed, Treatment-naïve Prostate Cancer
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Male |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 9 sites (Lanzhou, Gansu and 8 other locations) |
| Trial ID | NCT07474142 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lanzhou, Gansu and 8 other locations
- 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)
- 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 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.