A Multicenter, Prospective Study on the Prognostic Value of PSMA PET in Patients With Newly Diagnosed, Treatment-naïve Prostate Cancer
PSMA-VISION
1 other identifier
observational
1,000
1 country
9
Brief 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.
- 4.Patients undergone any prior prostate cancer treatment before undergoing PSMA PET imaging.
- 5.Patients with metastasized or disseminated malignancy other than prostate cancer
- 6.Patients with neuroendocrine prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2026
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 3, 2026
CompletedFirst Submitted
Initial submission to the registry
March 11, 2026
CompletedFirst Posted
Study publicly available on registry
March 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 3, 2036
March 16, 2026
March 1, 2026
2 years
March 11, 2026
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
PFS is defined as the time from the date of baseline PSMA PET/CT to the date of first documented evidence of disease progression or death from any cause, whichever occurs first. Disease progression includes any of the following events: Biochemical recurrence (BCR): For patients without metastasis (M0) at baseline, defined per EAU/NCCN criteria as a PSA rise to ≥ 0.2 ng/mL (post-radical prostatectomy) and confirmed on a subsequent test, or a rise of ≥ 2 ng/mL above the nadir (post-radiotherapy). Locoregional progression: Imaging or pathologically confirmed local recurrence or regional lymph node metastasis. Distant metastasis: Imaging-confirmed new distant metastasis (M1a-c). Initiation of subsequent anticancer therapy: Start of a new line of treatment (e.g., ADT, chemotherapy, radiotherapy) due to disease progression.
Up to 2 years
Secondary Outcomes (1)
Overall survival
Up to 10 years
Interventions
No.
Eligibility Criteria
Newly diagnosed, treatment-naïve prostate cancer patients
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
- Air Force Military Medical University, Chinacollaborator
- Shaanxi Provincial People's Hospitalcollaborator
- Weinan Central Hospitalcollaborator
- LanZhou Universitycollaborator
- Affiliated Hospital of Qinghai Universitycollaborator
- General Hospital of Ningxia Medical Universitycollaborator
- Yan'an University Affiliated Hospitalcollaborator
- The Second Affiliated Hospital of Shaanxi University of Chinese Medicinecollaborator
Study Sites (9)
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Qinghai University Affiliated Hospital
Xining, Qinghai, China
Weinan Central Hospital
Weinan, Shaanxi, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710032, China
Xijing 986 Hospital
Xi'an, Shaanxi, 710032, China
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032, China
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi, China
Affiliated Hospital of Yan'an University
Yan’an, Shaanxi, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2026
First Posted
March 16, 2026
Study Start
March 3, 2026
Primary Completion (Estimated)
March 3, 2028
Study Completion (Estimated)
March 3, 2036
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share