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

Summary

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.

Conditions

• Newly Diagnosed, Treatment-naïve Prostate Cancer

Interventions

OTHER

Not provided

No.

Sponsors & Collaborators

• Air Force Military Medical University, China

  collaborator OTHER

• Shaanxi Provincial People's Hospital

  collaborator OTHER

• Yan'an University Affiliated Hospital

  collaborator OTHER

• Weinan Central Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

  collaborator UNKNOWN

• LanZhou University

  collaborator OTHER

• Affiliated Hospital of Qinghai University

  collaborator OTHER

• General Hospital of Ningxia Medical University

  collaborator OTHER

• Xijing Hospital

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-03

Primary Completion

2028-03-03

Completion

2036-03-03

Countries

• China

Study Locations