---
title: Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
nct_id: NCT04011865
overall_status: UNKNOWN
phase: NA
sponsor: Binh Dan Hospital
study_type: INTERVENTIONAL
primary_condition: Prostate Cancer
countries: Vietnam
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04011865.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04011865"
ct_last_update_post_date: 2020-07-14
last_seen_at: "2026-05-12T07:18:25.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment

**NCT ID:** [NCT04011865](https://clinicaltrials.gov/study/NCT04011865)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 80
- **Lead Sponsor:** Binh Dan Hospital
- **Conditions:** Prostate Cancer
- **Start Date:** 2019-01-01
- **Completion Date:** 2020-12-31
- **CT.gov Last Update:** 2020-07-14

## Brief Summary

This study is to compare the outcomes of robotic-assisted laparoscopic radical prostatectomy (RARP) and laparoscopic radical prostatectomy (LRP) for prostate cancer treatment in terms of perioperative surgical, functional and oncological outcomes.

## Detailed Description

Participants will either have robotic-assisted laparoscopic radical prostatectomy (RARP) or laparoscopic radical prostatectomy (LRP) as determined by the treating surgeon. All participants will undergo tests and questionnaires to determine urinary and erectile function, biopsies to determine perioperative surgical, functional and oncological outcomes. These assessments will be conducted pre-operatively, post-operatively and at certain follow-up time points up to 12 months.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** MALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Adult men aged 18 years and over;
2. Undergoing RARP or LRP. prostatectomy for prostate cancer at Binh Dan Hospital;
3. Clinically suitable for radical prostatectomy (cT1-3, No, Mo);
4. Cognitively able to give written informed consent for participation;
5. Elective procedure.

Exclusion Criteria:

1. The patient lacks the ability to consent for themselves;
2. Patients unwilling to undergo pre- and post-operative evaluation according to the protocol;
```

## Arms

- **Robotic-assisted surgery** (ACTIVE_COMPARATOR)
- **Laparoscopic surgery** (SHAM_COMPARATOR)

## Interventions

- **Radical prostatectomy** (PROCEDURE) — The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.

## Primary Outcomes

- **The console time** _(time frame: During the surgery)_ — The time which surgeon spends on the robot console by minuite
- **Mean of blood loss** _(time frame: During the surgery)_ — Milliliter
- **Perioperative transfusion rate (%)** _(time frame: Up to 1 month after operation)_ — The number of cases which will be transfused.
- **The rate of positive surgical margins, extracapsular extension, seminal vesicle invasion, (5)perineural invasion, the number of lymph node yield and node involvement,** _(time frame: Up to 1 week after operation)_ — Number of cases, based on the result of pathology.
- **Number of blood units transfused** _(time frame: Up to 1 week after operation)_ — Milliliter
- **the rate of conversion to open surgery, the rate of intraoperative incidents (%),** _(time frame: Up to 1 weeks after the surgery.)_ — Percentage
- **The postoperative recovery parameters using Numeric Pain Rating Scale (NPRS),** _(time frame: Up to 3 month after surgery)_ — The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain, in a total of 10 points, higher score means worse, with 0 means no pain and 10 is the worst pain. The mean score will be calculated to reflect the post-operative pain.
- **Change of hemoglobin from baseline** _(time frame: Up to 1 week after operation)_ — (mg/mL)
- **The drainage time** _(time frame: Up to 3 months after surgery)_ — (day),
- **To assess urethral catheter time, urethral catheter time** _(time frame: Up to 3 months after surgery)_ — (day)
- **To assess bowel movement recovery time,** _(time frame: Up to 1 week after surgery)_ — (day)
- **To assess postoperative hospital stay** _(time frame: Up to 1 month after surgery)_ — (day)
- **The rate of postoperative complications (including infections)** _(time frame: in day 3, day 7, and 1 month after surgery.)_ — Percentage
- **PSA level in blood** _(time frame: Before operation)_ — (mg/mL)
- **PSA level in blood** _(time frame: 6 weeks post-operation)_ — (mg/mL)
- **PSA level in blood** _(time frame: 3 months post-operation)_ — (mg/mL)
- **PSA level in blood** _(time frame: 6 months post-operation)_ — (mg/mL)
- **PSA level in blood** _(time frame: 12 months post-operation)_ — (mg/mL)
- **local and regional recurrences on sonography** _(time frame: through study completion, an average of 1 year)_ — including ultrasound when PSA rising or any indication of recurrent
- **local and regional recurrences, on MRI** _(time frame: through study completion, an average of 1 year)_ — including MRI when PSA rising or any indication of recurrent
- **local and regional recurrences, on PET Scan** _(time frame: through study completion, an average of 1 year)_ — including PET Scan, when PSA rising or any indication of recurrent

## Secondary Outcomes

- **Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)** _(time frame: Preoperative)_
- **Evaluating the pre and postoperative lower urinary tract symptoms using International Prostate Symptoms Scores (IPSS)** _(time frame: 3 months postoperative)_
- **Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)** _(time frame: 6 months, postoperative)_
- **Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)** _(time frame: 12 months postoperative.)_
- **Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score** _(time frame: Preoperative)_
- **Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score** _(time frame: 3 months, postoperative)_
- **Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score** _(time frame: 6 months, postoperative.)_
- **Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score** _(time frame: 12 months postoperative)_
- **The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire** _(time frame: Preoperative)_
- **The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire** _(time frame: 3 months, postoperative.)_
- **The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire** _(time frame: 6 months, postoperative)_
- **The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire** _(time frame: 12 months postoperative)_

## Locations (1)

- Binh Dan Hospital, Ho Chi Minh City, Vietnam — _RECRUITING_

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.binh dan hospital|ho chi minh city||vietnam` — added _(2026-05-12)_

---

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