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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Hospital of Lanzhou University
RECRUITING
Lanzhou
Weinan Central Hospital
RECRUITING
Weinan
Shaanxi Provincial People's Hospital
RECRUITING
Xi'an
Xijing 986 Hospital
RECRUITING
Xi'an
Xijing Hospital, Fourth Military Medical University
RECRUITING
Xi'an
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
RECRUITING
Xianyang
Qinghai University Affiliated Hospital
RECRUITING
Xining
Affiliated Hospital of Yan'an University
RECRUITING
Yan’an
General Hospital of Ningxia Medical University
RECRUITING
Yinchuan
Contact Information
Primary
Jianhua Jiao, MD.
1531769428@qq.com
+86 18700919857
Time Frame
Start Date: 2026-03-03
Estimated Completion Date: 2036-03-03
Participants
Target number of participants: 1000
Related Therapeutic Areas
Sponsors
Collaborators: Affiliated Hospital of Qinghai University, Weinan Central Hospital, The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Air Force Military Medical University, China, LanZhou University, Shaanxi Provincial People's Hospital, Yan'an University Affiliated Hospital, General Hospital of Ningxia Medical University
Leads: Xijing Hospital

This content was sourced from clinicaltrials.gov