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Not yet recruiting NCT06707974

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

Observational Prostatic Neoplasms ctDNA

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Prostatic Neoplasms, ctDNA. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prognostic Study of Prostate Cancer Via Dynamic Change of Drainage Tumor DNA(dT-DNA) in Peritoneal Drainage Fluid After Radical Prostatectomy

Overview

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.

Primary outcome measures

  • dT-DNA Levels in Drainage Fluid [Time frame: Measured daily for up to 3 days post-surgery]

Eligibility criteria

Inclusion criteria

  • Prostate cancer patients treated with radical prostatectomy

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Shanghai General Hospital — Shanghai

Identifiers

NCT: NCT06707974 · YLY-dT DNA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗