Status:
NOT_YET_RECRUITING
Comparison of Nerve-sparing Techniques in Radical Prostatectomy for Oncological Outcome and Functional Recovery.
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Brief Summary
To evaluate the difference among three nerve-sparing techniques(unilateral intrafascial resection, bilateral intrafascial resection, bilateral extrafascial resection) of oncological outcome and functi...
Detailed Description
Surgery is a common and effective treatment for localized prostate cancer. The main objective of surgical treatment is to remove the tumor completely in order to achieve the goal of cure. Intrafascial...
Eligibility Criteria
Inclusion
- Men aged ≥18 years and ≤80 years;
- Histologically proven prostate adenocarcinoma with clinical stage \< T3(no capsule break)
- Clinically localized prostate cancer in very low, low, or intermediate risk groups according to National Comprehensive Cancer Network(NCCN) guidelines (2019 v4) ;
- Eastern Cooperative Oncology Group(ECOG) score of 0 or 1;
- Life expectancy greater than 10 years;
- Patients who are willing to accept robot-assisted radical prostatectomy after informed existing treatment plan, must sign the informed consent form.
Exclusion
- Surgeon thinks that the patient has an unresectable disease;
- patients who have already applied androgen deprivation therapy(ADT);
- Preoperative images suggest that the local lymph nodes were larger than 2 cm or suggest bone or distant metastasis;
- Any contraindication;
- Previous treatment of prostate cancer, including but not limited to surgery, hormone therapy, chemotherapy, radiotherapy, targeted therapy and immunotherapy;
- Patients with a history of transurethral resection or enucleation of the prostate;
- Severe systemic disease that may interfere with the data, assessment, or compliance;
- Patients who are participating in other clinical trials;
- Refusing to sign the informed consent
- Patients that are considered to be not suitable to be included by the researchers.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06524219
Start Date
October 1 2024
End Date
October 1 2029
Last Update
August 19 2024
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