Clinical trial NCT06707974: Prognostic Study of Via Dynamic Change of dT-DNA in Drainage Fluid After Radical Prostatectomy
Official title: Prognostic Study of Prostate Cancer Via Dynamic Change of Drainage Tumor DNA(dT-DNA) in Peritoneal Drainage Fluid After Radical Prostatectomy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostatic Neoplasms
ctDNA
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include male patients diagnosed with prostate cancer who need radical prostatectomy. Participants must have a preoperative diagnosis confirmed by biopsy and imaging studies. Eligible patients will have an abdominal drainage system in place post-surgery for fluid collection.

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.

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).

Primary outcomes:
measure: dT-DNA Levels in Drainage Fluid
timeFrame: Measured daily for up to 3 days post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
affiliation: https://www.shgh.cn/home/index.html
name: Huaqi Zhan
role: STUDY_CHAIR
References: