NCT07474142 A Multicenter, Prospective Study on the Prognostic Value of PSMA PET in Patients With Newly Diagnosed, Treatment-naïve Prostate Cancer
| NCT ID | NCT07474142 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xijing Hospital |
| Condition | Newly Diagnosed, Treatment-naïve Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-03-03 |
| Primary Completion | 2028-03-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2026-03-03 with a primary completion date of 2028-03-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07474142 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 100 Years, studying Newly Diagnosed, Treatment-naïve Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07474142 currently recruiting?
Yes, NCT07474142 is actively recruiting participants. Contact the research team at 1531769428@qq.com for enrollment information.
Where is the NCT07474142 trial being conducted?
This trial is being conducted at Lanzhou, China, Yinchuan, China, Xining, China, Weinan, China and 5 additional locations.
Who is sponsoring the NCT07474142 clinical trial?
NCT07474142 is sponsored by Xijing Hospital. The trial plans to enroll 1,000 participants.
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