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NCT06524219Not yet recruiting

Comparison of Nerve-sparing Techniques in Radical Prostatectomy for Oncological Outcome and Functional Recovery.

A Prospective, Multi-center, Real-world Study on the Comparison of Different Nerve-sparing Techniques in Retzius-sparing Robot-assisted Radical Prostatectomy for Oncological Outcome and Functional Recovery.

Source: ClinicalTrials.gov · Last updated 19 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

To evaluate the difference among three nerve-sparing techniques(unilateral intrafascial resection, bilateral intrafascial resection, bilateral extrafascial resection) of oncological outcome and functional recovery.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
150 (estimated)
First submitted
17 Jul 2024
Start date
1 Oct 2024
Primary completion date
1 Oct 2029
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
NCT number
NCT06524219

What you commit to

  • Study type: Observational
  • Planned participants: 150
  • From 1 Oct 2024 to the primary completion date, 1 Oct 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • patients who have already applied androgen deprivation therapy(ADT);
  • Previous treatment of prostate cancer, including but not limited to surgery, hormone therapy, chemotherapy, radiotherapy, targeted therapy and immunotherapy;

Other illness

  • Surgeon thinks that the patient has an unresectable disease;
  • Patients with a history of transurethral resection or enucleation of the prostate;
  • Severe systemic disease that may interfere with the data, assessment, or compliance;

Other

  • Preoperative images suggest that the local lymph nodes were larger than 2 cm or suggest bone or distant metastasis;
  • Any contraindication;
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.