Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment

NCT ID: NCT04011865

Last Updated: 2020-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Robotic-assisted surgery

Group Type ACTIVE_COMPARATOR

Radical prostatectomy

Intervention Type PROCEDURE

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

Laparoscopic surgery

Group Type SHAM_COMPARATOR

Radical prostatectomy

Intervention Type PROCEDURE

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

Interventions

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Radical prostatectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Binh Dan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hung V Tran, MD, PhD

Role: STUDY_DIRECTOR

Binh Dan Hospital

Locations

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Binh Dan Hospital

Ho Chi Minh City, , Vietnam

Site Status RECRUITING

Countries

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Vietnam

Central Contacts

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Hoang PC Nguyen, Associate Professor, MD, PhD

Role: CONTACT

+84 913 719 346

Linh NK Tran, MD, PhD

Role: CONTACT

+84 989 047 088

Facility Contacts

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Hoang PC Nguyen, Associate Professor, MD, PhD

Role: primary

+84 913 719 346

Other Identifiers

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BD022019

Identifier Type: -

Identifier Source: org_study_id

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