Prostate CancerNCT03706508
Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy
An observational study of Prostate Cancer and Erectile Dysfunction, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Robot-assisted laparoscopic radical prostatectomy (RALRP) is a surgical technique for the treatment of prostate cancer. The aim of this study was to report our initial experience with RALRP, by applying the concept of pentafecta. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Erectile Dysfunction, Complication of Surgical Procedure
- What is being tested?
- Robot-assisted laparoscopic radical prostatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Aug 2013to 30 Nov 2018
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients between 40 and 75 diagnosed with localized prostate cancer submitted to robot-assisted laparoscopic radical prostatectomy.
Who may be able to join
- patients diagnosed with localized Prostate Adenocarcinoma submitted to surgical treatment with Robot-assisted laparoscopic radical prostatectomy
Who cannot join
- patients undergoing other treatments for adenocarcinoma of the prostate
- conversion to open prostatectomy
- loss of follow-up
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035 007
Brasil S Neto, PhD, +55 51 33598286, bneto@hcpa.edu.br
About this study
Official title: Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy: First 120 Cases in Brazilian University Hospital
Robot-assisted laparoscopic radical prostatectomy (RALRP) is a surgical technique for the treatment of prostate cancer. The aim of this study was to report our initial experience with RALRP, by applying the concept of pentafecta. Pentafecta consists of the five main outcomes in the postoperative period of RALRP: erectile dysfunction, urinary incontinence, postoperative complications, surgical margins and biochemical failure.
Read the detailed description
This study will describe a initial experience in RALRP in Brazilian University Hospital. The follow-up of patients was performed as an examination at the medical consultation every three months. Complications were categorized according to the Clavien classification system. Biochemical failure was established by PSA level. Continence was defined as patients who remain dry and who do not require any kind of protection in their everyday activities. Sexual potency was defined as the ability to get and keep an erection for long enough to have satisfying sexual relations with or without the use of type-5 phosphodiesterase inhibitors (PDE-5) and a Sexual Health Inventory for Men (SHIM) score greater or equal to 21. Positive surgical margin is defined as the presence of neoplastic glands in direct contact with the ink on the surface of the piece, with no interposed connective tissue.
- Conditions
- Prostate Cancer, Erectile Dysfunction, Complication of Surgical Procedure, Urinary Incontinence
- Being tested
- Robot-assisted laparoscopic radical prostatectomy
- Keywords
- Robot-assisted prostatectomy, Pentafecta, Biochemical failure, Surgical margin
- Medical subject headings
- Prostatic Neoplasms, Erectile Dysfunction, Urinary Incontinence, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted laparoscopic radical prostatectomyProcedure or surgery
Patients with localized prostate cancer underwent transperitoneal robot-assisted laparoscopic radical prostatectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile Dysfunction
Sexual Health Inventory for Men (SHIM) score greater or equal to 21.
Measured: 6 months
Secondary outcomes (4)
Urinary Continence
Continence was defined as patients who remain dry and who do not require any kind of protection.Patients will be questioned in the postoperative consultations if there is a need to use some protection.
Measured: 6 months
Surgical Complication
Complications were categorized according to the Clavien classification system.
Measured: 30 days
Biochemical Failure
Biochemical failure was established by PSA level grater or equal to 0,2 ng/ml.
Measured: 6 month
Surgical Margin
It is defined as the presence of neoplastic glands in direct contact with the ink on the surface of the piece.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start9 Aug 2013
- Primary completion30 Nov 2018 (estimated)
- Study completion30 Nov 2018 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brasil S Neto, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706508
- Sponsor's protocol ID
- 2016/0457
- Status last verified
- Sep 2018
- First submitted
- 11 Oct 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy: First 120 Cases in Brazilian University Hospital
- ClinicalTrials.gov ID
- NCT03706508
- Acronym / sponsor ID
- 2016/0457
- Conditions
- Prostate Cancer, Erectile Dysfunction, Complication of Surgical Procedure, Urinary Incontinence
- Keywords
- Robot-assisted prostatectomy, Pentafecta, Biochemical failure, Surgical margin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 9 Aug 2013 (actual)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 30 Nov 2018 (estimated)
- First posted
- 16 Oct 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.
Robot-assisted laparoscopic radical prostatectomy (RALRP) is a surgical technique for the treatment of prostate cancer. The aim of this study was to report our initial experience with RALRP, by applying the concept of pentafecta. Pentafecta consists of the five main outcomes in the postoperative period of RALRP: erectile dysfunction, urinary incontinence, postoperative complications, surgical margins and biochemical failure.
Detailed description
This study will describe a initial experience in RALRP in Brazilian University Hospital. The follow-up of patients was performed as an examination at the medical consultation every three months. Complications were categorized according to the Clavien classification system. Biochemical failure was established by PSA level. Continence was defined as patients who remain dry and who do not require any kind of protection in their everyday activities. Sexual potency was defined as the ability to get and keep an erection for long enough to have satisfying sexual relations with or without the use of type-5 phosphodiesterase inhibitors (PDE-5) and a Sexual Health Inventory for Men (SHIM) score greater or equal to 21. Positive surgical margin is defined as the presence of neoplastic glands in direct contact with the ink on the surface of the piece, with no interposed connective tissue.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between 40 and 75 diagnosed with localized prostate cancer submitted to robot-assisted laparoscopic radical prostatectomy.
Key inclusion criteria (1 listed)
- patients diagnosed with localized Prostate Adenocarcinoma submitted to surgical treatment with Robot-assisted laparoscopic radical prostatectomy
Key exclusion criteria (3 listed)
- patients undergoing other treatments for adenocarcinoma of the prostate
- conversion to open prostatectomy
- loss of follow-up
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 |
|---|---|---|
| Robot-assisted laparoscopic radical prostatectomyPatients with localized prostate cancer underwent transperitoneal robot-assisted laparoscopic radical prostatectomy | Procedure or surgery | – |
Primary outcome
Erectile Dysfunction
Time frame: 6 months
Sexual Health Inventory for Men (SHIM) score greater or equal to 21.
4 secondary outcomes
Urinary Continence
Time frame: 6 months
Surgical Complication
Time frame: 30 days
Biochemical Failure
Time frame: 6 month
Surgical Margin
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Individual participant dataSharing planned: Undecided
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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.
Brasil S Neto, PhD principal investigator
Hospital de Clinicas de Porto Alegre
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 and Erectile Dysfunction, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Oct 2018. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brasil S Neto, PhD (+55 51 33598286, bneto@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erectile Dysfunction (time frame: 6 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 30 Oct 2018.