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

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.

Study Overview

• Status: Recruiting
• Conditions: Newly Diagnosed, Treatment-naïve Prostate Cancer
• Intervention / Treatment: Other: Not provided

Detailed Description

Background Prostate-specific membrane antigen (PSMA) positron emission tomography (PET) has fundamentally transformed the staging paradigm for prostate cancer, demonstrating superior sensitivity and specificity compared to conventional imaging for the detection of metastatic disease . The Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) criteria were established to standardize PSMA PET reporting, enabling reproducible and anatomically consistent disease characterization . Recent large-scale, international multi-centre studies have validated the robust prognostic value of PSMA-PET PROMISE (PPP) nomograms. These tools have shown superior accuracy in stratifying risk for overall survival across all disease stages when compared to established clinical risk tools such as the NCCN and EAU risk scores . The quantitative and visual PPP nomograms, incorporating parameters such as distant metastatic burden (M1a, M1b, M1c), total tumour volume, and PSMA expression score, have achieved C-indices of 0.77-0.80 for predicting overall survival, confirming the powerful prognostic information embedded within PSMA PET imaging .

Need While the prognostic utility of PSMA PET is established, previous studies, including the foundational PPP nomogram development, have largely enrolled cohorts comprising patients with mixed disease states-including those at initial staging, biochemical recurrence, and metastatic castration-resistant prostate cancer . This heterogeneity represents a significant confounder. The inclusion of patients with varying prior treatment exposures (e.g., post-radical prostatectomy, post-radiotherapy, post-systemic therapy) and at disparate points in their disease trajectory may obscure the true baseline prognostic power of the initial staging scan . A critical evidence gap remains regarding the specific prognostic value of the first, pre-treatment PSMA PET scan in a uniformly treatment-naïve population undergoing initial staging. Existing data on the direct correlation between baseline quantitative PSMA PET parameters and long-term outcomes like progression-free survival (PFS) in this specific, homogeneous cohort are lacking. As noted in recent literature, while PSMA PET provides unprecedented risk stratification, its direct impact on patient outcomes and the optimal integration of its quantitative metrics into prognostic tools for untreated patients require further prospective validation .

Aim / Objective

Primary Outcomes:

The primary aim of this study is to prospectively investigate the prognostic value of baseline staging PSMA PET for predicting progression-free survival (PFS) in patients with newly diagnosed, histologically confirmed, treatment-naïve prostate cancer. We will develop and validate a dedicated prognostic tool (nomogram or risk model) incorporating baseline PSMA PET parameters (e.g., SUVmax, lesion count, metastatic stage [miTNM]) alongside standard clinico-pathological variables to stratify patients by risk of disease progression.

Secondary Outcomes:

1. Comparison with Established Prognostic Tools: To compare the prognostic performance of the PSMA PET-based model (PSMA-VISION score) for PFS against established risk stratification systems, including NCCN risk categories and the PSMA PET Prognosis (PPP) nomogram.
2. Correlation with Clinicopathological Variables: To assess the association between PSMA PET parameters (e.g., miTNM stage, total tumor volume, PSMA-VISION score) and standard clinical variables (Gleason grade group, baseline PSA, ISUP risk category).
3. Prediction of Early Progression (Exploratory): To evaluate the ability of baseline PSMA PET parameters to predict early disease progression, defined as PFS event occurring within 12 months of diagnosis.
4. Exploratory Analysis of Overall Survival: To explore the association between baseline PSMA PET parameters and overall survival (OS), acknowledging the limited 2-year follow-up duration.

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.

Statistical considerations:

This is an observational cohort study leveraging prospectively collected data from various centers. The sample size is determined by the availability of eligible patients meeting the inclusion criteria during the study period, with a planned enrollment of approximately 1000 patients.

Given the exploratory nature of this study and the absence of pre-specified effect sizes, a formal sample size calculation was not performed. However, with a minimum follow-up of 2 years for progression-free survival (PFS), we anticipate a sufficient number of PFS events to enable multivariable regression analyses. Based on the 10 events per variable (EPV) rule of thumb , this sample size will support the inclusion of 10 key predictor variables in the final model.

The prognostic value of baseline PSMA PET parameters (including PSMA-VISION score, miTNM stage, and SUV metrics) for PFS will be assessed using Cox proportional hazards regression models. Hazard ratios (HR) with 95% confidence intervals (CI) will be reported. The proportional hazards assumption will be tested using Schoenfeld residuals.

The predictive performance of the PSMA-VISION score will be evaluated using Harrell's C-index for time-to-event data. The C-index quantifies the model's ability to discriminate between patients with different PFS outcomes. To compare the prognostic performance of the PSMA-VISION score against established risk tools (NCCN risk categories, PPP nomogram), we will calculate the difference in C-indices with 95% CIs, using bootstrap resampling (1000 replicates) to account for over-optimism.

For the secondary endpoint comparing PSMA-VISION with other prognostic tools, time-dependent receiver operating characteristic (ROC) curve analysis will be performed, and the area under the curve (AUC) at 12 and 24 months will be calculated and compared using the method of DeLong et al.

As this is an open cohort study, continuous data accrual will improve the precision of prognostic estimates. All statistical tests will be two-sided, with p < 0.05 considered statistically significant. Analyses will be performed using R software (version 4.x) with relevant packages (e.g., survival, timeROC, compareC).

Central Database:

Data will be stored centrally in a RedCap Database with 3-step authentication at the sponsor site.

Recurring Data Entry:

Data entry will be conducted repeatedly at about 3 to 6 month intervals.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Jianhua Jiao, MD.; Phone Number: +86 18700919857; Email: 1531769428@qq.com

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China
      • Recruiting
      • The First Hospital of Lanzhou University
      • Contact: Wei Zhang; Phone Number: +86 18700919857; Email: 1531769428@qq.com
      • Principal Investigator: Wei Zhang, MD.
  • Ningxia
    • Yinchuan, Ningxia, China
      • Recruiting
      • General Hospital of Ningxia Medical University
      • Contact: Zhiyong Lv, MD.; Phone Number: +86 18700919857; Email: 1531769428@qq.com
      • Principal Investigator: Zhiyong Lv, MD.
  • Qinghai
    • Xining, Qinghai, China
      • Recruiting
      • Qinghai University Affiliated Hospital
      • Contact: Guojun Chen, MD.; Phone Number: +86 18700919857; Email: 1531769428@qq.com
      • Principal Investigator: Guojun Chen, MD.
  • Shaanxi
    • Weinan, Shaanxi, China
      • Recruiting
      • Weinan Central Hospital
      • Contact: Weihong Zhao, MD.; Phone Number: +86 18700919857; Email: 1531769428@qq.com
      • Principal Investigator: Weihong Zhao, MD.
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital, Fourth Military Medical University
      • Contact: Jiao, MD.; Phone Number: +86 18700919857; Email: 1531769428@qq.com
      • Principal Investigator: Weijun Qin, MD.
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Shaanxi provincial people's hospital
      • Contact: Yi Sun, MD.; Phone Number: +86 18700919857; Email: 1531769428@qq.com
      • Principal Investigator: Yi Sun, MD.
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing 986 Hospital
      • Principal Investigator: Wuhe Zhang, MD.
      • Contact: Wuhe Zhang, MD.; Phone Number: +8618700919857; Email: 1531769428@qq.com
    • Xianyang, Shaanxi, China
      • Recruiting
      • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
      • Contact: Wei Zheng, MD.; Phone Number: +86 18700919857; Email: 1531769428@qq.com
      • Principal Investigator: Wei Zheng, MD.
    • Yan’an, Shaanxi, China
      • Recruiting
      • Affiliated Hospital of Yan'an University
      • Contact: Jixue Gao, MD.; Phone Number: +86 18700919857; Email: 1531769428@qq.com
      • Principal Investigator: Jixue Gao, MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed, treatment-naïve prostate cancer patients

Description

Inclusion Criteria:

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Time from PSMA-PET until death	Up to 10 years

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: LanZhou University; Shaanxi Provincial People's Hospital; Air Force Military Medical University, China; General Hospital of Ningxia Medical University; Affiliated Hospital of Qinghai University; Weinan Central Hospital; Yan'an University Affiliated Hospital; The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2026
• Primary Completion (Estimated): March 3, 2028
• Study Completion (Estimated): March 3, 2036

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: prostate cancer; prognosis; nomogram; PSMA PET
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: KY20262015-F-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No