A Multicenter, Prospective Study on the Prognostic Value of PSMA PET in Patients With Newly Diagnosed, Treatment-naïve Prostate Cancer

Recruiting now

Conditions studied: Newly Diagnosed, Treatment-naïve Prostate Cancer

In brief

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.

Key facts

Study ID

NCT07474142

Run by

Xijing Hospital

People needed

1000

Starts

2026-03-03

Expected to finish

2036-03-03

Last updated by the study team

2026-03-16

Who can join

Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patients with pathologically confirmed prostate cancer by prostate biopsy.
• Undergone PSMA PET examination as initial staging before any treatment.
• Have at least 2 years of follow-up data for progression-free survival and overall survival.

You may not qualify if…

• Patients undergone any prior prostate cancer treatment before undergoing PSMA PET imaging.
• Patients with metastasized or disseminated malignancy other than prostate cancer.
• Patients with neuroendocrine prostate cancer.

Where it is running

• The First Hospital of Lanzhou University — Lanzhou, Gansu, China (enrolling)
• General Hospital of Ningxia Medical University — Yinchuan, Ningxia, China (enrolling)
• Qinghai University Affiliated Hospital — Xining, Qinghai, China (enrolling)
• Weinan Central Hospital — Weinan, Shaanxi, China (enrolling)
• Shaanxi Provincial People's Hospital — Xi'an, Shaanxi, China (enrolling)
• Xijing 986 Hospital — Xi'an, Shaanxi, China (enrolling)
• Xijing Hospital, Fourth Military Medical University — Xi'an, Shaanxi, China (enrolling)
• The Second Affiliated Hospital of Shaanxi University of Chinese Medicine — Xianyang, Shaanxi, China (enrolling)
• Affiliated Hospital of Yan'an University — Yan’an, Shaanxi, China (enrolling)

Full record on ClinicalTrials.gov

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