NCT01578356

Brief Summary

For primary surgical treatment of prostate cancer the investigators compare the classic open surgery (radical retropubic prostatectomy, RRP) versus robot-assisted laparoscopic surgery (RALP). Oncological results are obtained at standard follow-up consultations through Prostate-Specific Antigen (PSA) measurement to detect biochemical recurrence. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Currently the investigators perform all of their prostatectomies in a robot-assisted manner. For results of the open surgery the investigators send questionnaires to patients who had the operation in the past.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2012

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

2.8 years

First QC Date

April 12, 2012

Last Update Submit

January 2, 2023

Conditions

Prostate Cancer

Keywords

Prostate cancer

Outcome Measures

Primary Outcomes (5)

  • Biochemical recurrence at follow-up.

    PSA measurement in the serum should not be \> or = 0,20 ng/ml.

    3 months after prostatectomy

  • Biochemical recurrence at follow-up

    PSA measurement in the serum should not be \> or = 0,20 ng/ml.

    6 months after prostatectomy

  • Biochemical recurrence at follow-up.

    PSA measurement in the serum should not be \> or = 0,20 ng/ml.

    9 months after prostatectomy

  • Biochemical recurrence at follow-up.

    PSA measurement in the serum should not be \> or = 0,20 ng/ml.

    1 year after prostatectomy

  • Biochemical recurrence at follow-up.

    PSA measurement in the serum should not be \> or = 0,20 ng/ml.

    6-monthly follow up between 1 and 5 years after prostatectomy.

Secondary Outcomes (3)

  • Functional assessment concerning continence.

    after 1, 3, 12 and 24 months

  • Functional assessment concerning potency.

    after 1, 3, 12 and 24 months

  • Functional assessment concerning quality of life.

    after 1, 3, 12 and 24 months

Study Arms (2)

Radical Retropubic prostatectomy (RRP)

Men who underwent open radical prostatectomy in the past at our centre.

Robot-assisted laparoscopic prostatectomy (RALP)

Men who undergo robot-assisted laparoscopic prostatectomy at our centre.

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men who were surgically treated or who are being surgically treated for prostate cancer.

You may qualify if:

  • prostate cancer
  • radical retropubic prostatectomy or
  • robot-assisted laparoscopic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Nicolaas Lumen, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2012

First Posted

April 16, 2012

Study Start

January 1, 2009

Primary Completion

October 31, 2011

Study Completion

October 31, 2012

Last Updated

January 4, 2023

Record last verified: 2023-01

Locations

BE(1)