Prostate CancerNCT03550040
3D Versus Robot Assisted Laparoscopic Prostatectomy.
A study testing Radical prostatectomy in people with Prostate Cancer, run by Tampere University Hospital at 1 site in Finland.
Trial summary
A randomized, prospective study to compare the direct and indirect costs, functional and oncologic results of 3D laparoscopic and robot assisted radical prostatectomy procedures. Read more about this study
- Who is it for?
- Ages 34 to 74 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radical prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteFinland
- Study dates
- 31 May 2018to 30 Jul 2022
- Phase
- Interventional
- 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 34 to 74 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Localized prostate cancer undergoing radical prostatectomy
- Patient has to understand and be able to write and read Finnish language
- No prior head injury, dementia or Parkinson's disease
- No concomitant malignant illness
- Life expectancy of at least 10 years
- 35-74 years of age
Who cannot join
- Locally advanced prostate cancer (T4)
- Suspicion or documented metastases (M1)
- Serum PSA > 20 ng/ml
- Prior laparoscopic hernia surgery employing non resorbable mesh
- Prior pelvic irradiation or major surgery
- Prior malignant disease within prior 5 years excluding skin cancer (non-melanoma).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3D Versus Robot Assisted Laparoscopic Prostatectomy. A Prospective Randomized Non-inferiority Study.
A randomized, prospective study to compare the direct and indirect costs, functional and oncologic results of 3D laparoscopic and robot assisted radical prostatectomy procedures.
Read the detailed description
The direct and indirect costs, functional and oncologic results of robot assisted radical prostatectomy (RALP) are compared to those of 3D laparoscopic radical prostatectomy. The hypothesis of the study is that the functional and oncologic results of the two operative methods are equal, but the direct costs of RAPL are significantly higher. A randomized, prospective non-inferiority study will will enroll 280 patients randomized 1:1 to both operative approaches to test this hypothesis. The primary functional outcome measure is the proportion of patients with complete urinary continence (no protective pad use) at 12 months post operatively. Secondary functional outcome measure is the preservation erectile function at 12 months post operatively. Oncologic outcome measures are the proportion of patients with undetectable post operative prostate specific antigen levels and positive surgical margins at pathological examination. The direct and indirect costs of both operative approaches are recorded.
- Conditions
- Prostate Cancer
- Being tested
- Radical prostatectomy
- Keywords
- radical prostatectomy, laparoscopic prostatectomy, robot assisted prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical prostatectomyProcedure or surgery
Also called Total prostatectomy
Surgical removal of the prostate
| Study group | Role | What they receive |
|---|---|---|
| Robot assisted prostatectomy. | Active comparator | Intervention: radical prostatectomy Receives: Procedure: Radical prostatectomy |
| 3D laparoscopic prostatectomy | Experimental | Intervention: radical prostatectomy Receives: Procedure: Radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary continence
Expanded Prostate Cancer Index Composite (EPIC) Short Form (EPIC-26), urinary domain score is used to assess the return of continence post operatively. The percentage of patients with no protective pad use at 12 months post operatively is the main outcome measure.
Measured: 12 months
Secondary outcomes (3)
Erectile function
International Index of Erectile Function (IIEF-5) Questionnaire score is used to quantify the return of erectile function post operatively.
Measured: 12 months
Prostate specific antigen
Post operative prostate specific antigen levels.
Measured: 12 months
Evaluation of surgical margins at pathologic examination.
The oncological outcome is evaluated by the presence of cancerous tissue at the surgical margins of the specimen at pathologic examination.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start31 May 2018
- Primary completion30 Jul 2021
- Study completion30 Jul 2022
Why it stopped: accrual was sufficient at interim analysis to draw final conclusions needed to publish
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized study
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seinajoki Central Hospital
- Responsible party
- Principal investigator, Antti Kaipia, Tampere University Hospital
- Investigators
- Antti Kaipia, M.D., Ph.D., Principal investigator, chief, dept of urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550040
- Sponsor's protocol ID
- 18005
- Status last verified
- Nov 2023
- First submitted
- 14 May 2018
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient demographic, primary and secondary outcome measures available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Versus Robot Assisted Laparoscopic Prostatectomy. A Prospective Randomized Non-inferiority Study.
- ClinicalTrials.gov ID
- NCT03550040
- Acronym / sponsor ID
- 18005
- Conditions
- Prostate Cancer
- Keywords
- radical prostatectomy, laparoscopic prostatectomy, robot assisted prostatectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: accrual was sufficient at interim analysis to draw final conclusions needed to publish
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Seinajoki Central Hospital
- Study start
- 31 May 2018 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 8 Jun 2018 (actual)
- 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.
A randomized, prospective study to compare the direct and indirect costs, functional and oncologic results of 3D laparoscopic and robot assisted radical prostatectomy procedures.
Detailed description
The direct and indirect costs, functional and oncologic results of robot assisted radical prostatectomy (RALP) are compared to those of 3D laparoscopic radical prostatectomy. The hypothesis of the study is that the functional and oncologic results of the two operative methods are equal, but the direct costs of RAPL are significantly higher. A randomized, prospective non-inferiority study will will enroll 280 patients randomized 1:1 to both operative approaches to test this hypothesis. The primary functional outcome measure is the proportion of patients with complete urinary continence (no protective pad use) at 12 months post operatively. Secondary functional outcome measure is the preservation erectile function at 12 months post operatively. Oncologic outcome measures are the proportion of patients with undetectable post operative prostate specific antigen levels and positive surgical margins at pathological examination. The direct and indirect costs of both operative approaches are recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized study
| Arm | Type | Receives |
|---|---|---|
| Robot assisted prostatectomy. | Active comparator | Procedure: Radical prostatectomyIntervention: radical prostatectomy |
| 3D laparoscopic prostatectomy | Experimental | Procedure: Radical prostatectomyIntervention: radical prostatectomy |
Who may qualify
- Ages
- 34 to 74 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Localized prostate cancer undergoing radical prostatectomy
- Patient has to understand and be able to write and read Finnish language
- No prior head injury, dementia or Parkinson's disease
- No concomitant malignant illness
- Life expectancy of at least 10 years
Key exclusion criteria (6 listed)
- Locally advanced prostate cancer (T4)
- Suspicion or documented metastases (M1)
- Serum PSA > 20 ng/ml
- Prior laparoscopic hernia surgery employing non resorbable mesh
- Prior pelvic irradiation or major surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical prostatectomyAlso: Total prostatectomySurgical removal of the prostate | Procedure or surgery | 3D laparoscopic prostatectomy, Robot assisted prostatectomy. |
Primary outcome
Urinary continence
Time frame: 12 months
Expanded Prostate Cancer Index Composite (EPIC) Short Form (EPIC-26), urinary domain score is used to assess the return of continence post operatively. The percentage of patients with no protective pad use at 12 months post operatively is the main outcome measure.
3 secondary outcomes
Erectile function
Time frame: 12 months
Prostate specific antigen
Time frame: 12 months
Evaluation of surgical margins at pathologic examination.
Time frame: up to 12 months
Results and safety
The study was stopped early (reason given: accrual was sufficient at interim analysis to draw final conclusions needed to publish). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: Yes. Patient demographic, primary and secondary outcome measures available upon request.
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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.
Antti Kaipia, M.D., Ph.D. principal investigator
chief, dept of urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical prostatectomy in people with Prostate Cancer, run by Tampere University Hospital at 1 site in Finland.
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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 24 Nov 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 Finland. 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 was stopped early (reason given: accrual was sufficient at interim analysis to draw final conclusions needed to publish). Results are not available in the source record.
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?
Urinary continence (time frame: 12 months). 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 24 Nov 2023.