Prognostic Study of Via Dynamic Change of dT-DNA in Drainage Fluid After Radical Prostatectomy

Not yet recruiting

• Conditions: Prostatic Neoplasms; ctDNA

• Registration Number: NCT06707974
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

This study investigates the prognostic value of dynamic changes in Drainage Tumor DNA(dT-DNA) levels found in the peritoneal drainage fluid after radical prostatectomy. Prostate cancer is one of the most common cancers in men, and radical prostatectomy is a standard treatment. While PSA levels in the blood are commonly used as a marker for diagnosis, this study focuses on the significance of dT-DNA levels in the prognosis of prostate cancer. The findings may provide insights into improved post-surgical monitoring and more tailored therapeutic strategies for prostate cancer patients.

Detailed Description

This study examines the prognostic significance of dT-DNA levels in the peritoneal drainage fluid following radical prostatectomy, a common surgical treatment for prostate cancer. PSA is widely used as a biomarker for prostate cancer diagnosis, treatment response, and recurrence monitoring in the blood. However, this research seeks to explore the prognostic value of dT-DNA in the drainage fluid.

The study involves continuous monitoring of dT-DNA levels in the drainage fluid after radical prostatectomy, with the hypothesis that dynamic changes in these levels could serve as an early warning system for potential tumor recurrence, residual disease, or metastasis. The research will correlate these fluid dT-DNA levels with patient outcomes, recurrence rates, and other clinical factors to determine their predictive value.

By investigating this novel source of dT-DNA monitoring, the study aims to reduce invasive tests, enhance post-operative surveillance, and improve early detection of disease recurrence for prostate cancer patients. This research could contribute to refining post-surgical care protocols, offering a new tool for predict long-term outcomes for individuals undergoing radical prostatectomy.

Study Timeline

• Study First Submitted: 2024-09-21
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Study Start: 2024-12-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Prostate cancer patients treated with radical prostatectomy

Read More

Exclusion Criteria

• 1. Received neoadjuvant endocrine/chemotherapy before surgery;
• 2. Urine leakage after surgery (positive creatinine test of drainage fluid).

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
dT-DNA Levels in Drainage Fluid	Measured daily for up to 3 days post-surgery	Postoperative dT-DNA Levels in The Peritoneal Drainage Fluid

Trial Locations

Locations (1)

Shanghai General Hospital; 🇨🇳 Shanghai, Shanghai, China