Prostate CancerNCT01578356
Oncological and Functional Outcomes After Radical Prostatectomy for Prostate Cancer: Comparing Open With Robot-assisted Surgery
An observational study of Prostate Cancer, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2009to 31 Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men who were surgically treated or who are being surgically treated for prostate cancer.
Who may be able to join
- prostate cancer
- radical retropubic prostatectomy or
- robot-assisted laparoscopic surgery
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical recurrence at follow-up.
PSA measurement in the serum should not be > or = 0,20 ng/ml.
Measured: 3 months after prostatectomy
Biochemical recurrence at follow-up
PSA measurement in the serum should not be > or = 0,20 ng/ml.
Measured: 6 months after prostatectomy
Biochemical recurrence at follow-up.
PSA measurement in the serum should not be > or = 0,20 ng/ml.
Measured: 9 months after prostatectomy
Biochemical recurrence at follow-up.
PSA measurement in the serum should not be > or = 0,20 ng/ml.
Measured: 1 year after prostatectomy
Biochemical recurrence at follow-up.
PSA measurement in the serum should not be > or = 0,20 ng/ml.
Measured: 6-monthly follow up between 1 and 5 years after prostatectomy.
Secondary outcomes (3)
Functional assessment concerning continence.
Patients need to fill out questionnaires (EORTC QLQ-C30, QLQ-PR25, ICIQ mLUTS and UI SF and IIEF). The patients in the radical retropubic prostatectomy group only fill out the questionnaires once.
Measured: after 1, 3, 12 and 24 months
Functional assessment concerning potency.
Patients need to fill out questionnaires (EORTC QLQ-C30, QLQ-PR25, ICIQ mLUTS and UI SF and IIEF). The patients in the radical retropubic prostatectomy group only fill out the questionnaires once.
Measured: after 1, 3, 12 and 24 months
Functional assessment concerning quality of life.
Patients need to fill out questionnaires (EORTC QLQ-C30, QLQ-PR25, ICIQ mLUTS and UI SF and IIEF). The patients in the radical retropubic prostatectomy group only fill out the questionnaires once.
Measured: after 1, 3, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study start1 Jan 2009
- Primary completion31 Oct 2011
- Study completion31 Oct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolaas Lumen, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578356
- Sponsor's protocol ID
- 2012/122
- Status last verified
- Jan 2023
- First submitted
- 12 Apr 2012
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncological and Functional Outcomes After Radical Prostatectomy for Prostate Cancer: Comparing Open With Robot-assisted Surgery
- ClinicalTrials.gov ID
- NCT01578356
- Acronym / sponsor ID
- 2012/122
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Oct 2011 (actual)
- Study completion
- 31 Oct 2012 (actual)
- First posted
- 16 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men who were surgically treated or who are being surgically treated for prostate cancer.
Key inclusion criteria (3 listed)
- prostate cancer
- radical retropubic prostatectomy or
- robot-assisted laparoscopic surgery
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biochemical recurrence at follow-up.
Time frame: 3 months after prostatectomy
PSA measurement in the serum should not be > or = 0,20 ng/ml.
Biochemical recurrence at follow-up
Time frame: 6 months after prostatectomy
PSA measurement in the serum should not be > or = 0,20 ng/ml.
Biochemical recurrence at follow-up.
Time frame: 9 months after prostatectomy
PSA measurement in the serum should not be > or = 0,20 ng/ml.
Biochemical recurrence at follow-up.
Time frame: 1 year after prostatectomy
PSA measurement in the serum should not be > or = 0,20 ng/ml.
Biochemical recurrence at follow-up.
Time frame: 6-monthly follow up between 1 and 5 years after prostatectomy.
PSA measurement in the serum should not be > or = 0,20 ng/ml.
3 secondary outcomes
Functional assessment concerning continence.
Time frame: after 1, 3, 12 and 24 months
Functional assessment concerning potency.
Time frame: after 1, 3, 12 and 24 months
Functional assessment concerning quality of life.
Time frame: after 1, 3, 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolaas Lumen, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical recurrence at follow-up. (time frame: 3 months after prostatectomy). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.