A Multicenter, Prospective Study on the Prognostic Value of PSMA PET in Patients With Newly Diagnosed, Treatment-naïve Prostate Cancer
About this study
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.
- Condition
- Newly Diagnosed, Treatment-naïve Prostate Cancer
- Tested
- Not provided
- Sponsor
- Xijing Hospital
Who can join
- Age
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 18 years
- Maximum age: 100 years
- Eligible sex: Male
- Study condition: Newly Diagnosed, Treatment-naïve Prostate Cancer
- 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.
Exclusion 3
- 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
9 sites, 9 recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Weinan Central Hospital
Weinan, Shaanxi, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Xijing 986 Hospital
Xi'an, Shaanxi, China
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi, China
and 3 more sites on ClinicalTrials.gov
Contact
-
Jianhua Jiao, MD.
+86 18700919857 1531769428@qq.com
Potential match only. Final eligibility is determined by the study team.