Trial · NCT07516704
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | pCR or MRD Rate | 1 month after surgery | :-\*\*pCR (Pathological Complete Response)\*\* is defined as the absence of morphologically identifiable cancer in the prostatectomy specimen. \- \*\*MRD (Minimal Residual Disease)\*\* is defined as a maximum cross-sectional diameter of residual tumor ≤ 5 mm, and using RCB (Residual Cancer Burden) ≤ 0.25 cm³ (tumor volume ≤ 0.5 cm³ × tumor cellularity ≤ 50%). Tumor volume is calculated by three-dimensional volume estimation based on the largest cross-sectional dimension of the tumor and the number of cross-sections, with adjustment for tumor cellularity. |
| Primary | PSA response rate | Defined as the comparison of PSA levels before neoadjuvant therapy and at the end of the neoadjuvant therapy cycle (before surgery). | |
| Primary | iochemical Progression-Free Survival (bPFS) after Radical Prostatectomy | 1 month after surgery | |
| Secondary | Pathological response after radical prostatectomy | 1 month after surgery | Pathological response after radical prostatectomy (including positive surgical margins, tumor size, extraprostatic extension, seminal vesicle invasion, and lymph node involvement) |
| Secondary | TNM stage | 1 month after surgery | Changes in TNM staging on imaging after neoadjuvant therapy and before surgery |
| Secondary | Other PFS | 1 month after surgery | Other Progression-Free Survival (progression includes radiographic progression, castration resistance, need for further therapeutic intervention, etc.) |
| Secondary | Safety indicator: CTCAE 5.0 adverse event grading | 1 month after surgery | |
| Secondary | Quality of life score: EORTC QLQ-C30 questionnaire | 1 month after surgery | |
| Other | Change in prespecified transcriptomic features in tumor tissue before and after neoadjuvant treatment | 1 month after surgery | Change in prespecified transcriptomic features measured in paired tumor tissue samples collected before treatment and at radical prostatectomy, assessed using bulk RNA sequencing and/or single-cell or spatial transcriptomic profiling. |
| Other | Change in prespecified proteomic features in tumor tissue before and after neoadjuvant treatment | 1 month after surgery | Change in prespecified proteomic features measured in paired tumor tissue samples collected before treatment and at radical prostatectomy, assessed using proteomic profiling. |
| Other | Change in prespecified intratumoral microbiome features before and after neoadjuvant treatment | 1 month after surgery | Change in prespecified intratumoral microbiome features measured in paired tumor tissue samples collected before treatment and at radical prostatectomy, including microbial composition, relative abundance of prespecified taxa, and diversity indices. |
| Other | Difference in tumor tissue molecular features between participants who achieve and do not achieve the primary endpoint | 1 month after surgery | Difference in prespecified transcriptomic and proteomic features in tumor tissue between participants who achieve the primary endpoint (pathological complete response or minimal residual disease) and those who do not, assessed using tissue obtained at radical prostatectomy. |
| Other | Change in prespecified liquid biopsy biomarkers before and after neoadjuvant treatment | 1 month after surgery | Change in prespecified liquid biopsy biomarkers measured in blood and/or urine samples collected before treatment and after completion of neoadjuvant therapy, including genomic, proteomic, and metabolomic indicators associated with treatment response. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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