Prostatic NeoplasmsNCT06608225
Prognostic Study of Prostate Cancer Via Dynamic Change of PSA in Peritoneal Drainage Fluid After Radical Prostatectomy
An observational study of Prostatic Neoplasms and Prostate-Specific Antigen, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study investigates the prognostic value of dynamic changes in Prostate-Specific Antigen (PSA) 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prostatic Neoplasms, Prostate-Specific Antigen
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 1 Dec 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Prostate cancer patients treated with radical prostatectomy
Who cannot join
- 1. Received neoadjuvant endocrine/chemotherapy before surgery;
- 2. Urine leakage after surgery (positive creatinine test of drainage fluid).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Huaqi Zhan, bachelor, +8618817532325, 18817532325@163.com
About this study
This study investigates the prognostic value of dynamic changes in Prostate-Specific Antigen (PSA) 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 PSA 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.
Read the detailed description
This study examines the prognostic significance of Prostate-Specific Antigen (PSA) 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 PSA in the drainage fluid.
The study involves continuous monitoring of PSA 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 PSA levels with patient outcomes, recurrence rates, and other clinical factors to determine their predictive value.
By investigating this novel source of PSA 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.
- Conditions
- Prostatic Neoplasms, Prostate-Specific Antigen
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA Levels in Drainage Fluid
Postoperative Prostate-Specific Antigen (PSA) Levels in The Peritoneal Drainage Fluid
Measured: Measured daily for up to 3 days post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Cheng, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Huaqi Zhan, bachelor, Study chair, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608225
- Sponsor's protocol ID
- YLY-PSA
- Status last verified
- Nov 2024
- First submitted
- 10 Sep 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Study of Prostate Cancer Via Dynamic Change of PSA in Peritoneal Drainage Fluid After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT06608225
- Acronym / sponsor ID
- YLY-PSA
- Conditions
- Prostatic Neoplasms, Prostate-Specific Antigen
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the prognostic value of dynamic changes in Prostate-Specific Antigen (PSA) 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 PSA 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 Prostate-Specific Antigen (PSA) 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 PSA in the drainage fluid.
The study involves continuous monitoring of PSA 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 PSA levels with patient outcomes, recurrence rates, and other clinical factors to determine their predictive value.
By investigating this novel source of PSA 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Prostate cancer patients treated with radical prostatectomy
Key exclusion criteria (2 listed)
- 1. Received neoadjuvant endocrine/chemotherapy before surgery;
- 2. Urine leakage after surgery (positive creatinine test of drainage fluid).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PSA Levels in Drainage Fluid
Time frame: Measured daily for up to 3 days post-surgery.
Postoperative Prostate-Specific Antigen (PSA) Levels in The Peritoneal Drainage Fluid
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huaqi Zhan, bachelor study chair
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms and Prostate-Specific Antigen, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huaqi Zhan, bachelor (+8618817532325, 18817532325@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA Levels in Drainage Fluid (time frame: Measured daily for up to 3 days post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.