Prostatic NeoplasmsNCT03241758
Vascular Changes Of Patients Undergoing Laparoscopic Radical Prostatectomy
An observational study of Prostatic Neoplasms and Erectile Dysfunction Following Radical Prostatectomy, run by Corporacion Parc Tauli.
Trial summary
A study designed to evaluate vascular changes after radical laparoscopic prostatectomy using Doppler ultrasound and the impact of such changes on erectile function and quality of life of patients. The baseline study will be compared with the study one year after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostatic Neoplasms, Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- Doppler ultrasound
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 29 Nov 2011to 2 Aug 2017
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients with prostate cancer who underwent laparoscopic radical prostatectomy
Who may be able to join
- Male patients with prostate cancer who underwent laparoscopic radical prostatectomy
Who cannot join
- Patients who were not interested in their sexual function and refused to perform this study
- Patients who required adjuvant or salvage treatment for their prostate cancer (radiation therapy, chemotherapy or androgen deprivation therapy) during follow-up.
About this study
Official title: Valuation Of Vascular Changes And Their Impact On Erectile Function By Penile Doppler Ultrasound And Analysis Of The Quality Of Life Of Patients Undergoing Laparoscopic Radical Prostatectomy
A study designed to evaluate vascular changes after radical laparoscopic prostatectomy using Doppler ultrasound and the impact of such changes on erectile function and quality of life of patients. The baseline study will be compared with the study one year after surgery.
- Being tested
- Doppler ultrasound
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasoundDiagnostic test
Basal Doppler ultrasound and Doppler ultrasound one year after radical prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| Group #1 | Patients with prostate cancer who will undergo radical prostatectomy Receives: Diagnostic Test: Doppler ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left and right Cavernous artery diameter
mm
Measured: 1 year
Left and right Systolic velocity cavernous artery
cm/s
Measured: 1 year
Left and right Diastolyc velocity cavernous artery
cm/s
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start29 Nov 2011
- Primary completion2 Aug 2017
- Study completion2 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesus Muñoz-Rodriguez, Corporacion Parc Tauli
- Investigators
- Jesus Muñoz-Rodriguez, MD, Principal investigator, Corporació Sanitaria Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241758
- Sponsor's protocol ID
- RadicalDoppler
- Status last verified
- Aug 2017
- First submitted
- 3 Aug 2017
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valuation Of Vascular Changes And Their Impact On Erectile Function By Penile Doppler Ultrasound And Analysis Of The Quality Of Life Of Patients Undergoing Laparoscopic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT03241758
- Acronym / sponsor ID
- RadicalDoppler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 29 Nov 2011 (actual)
- Primary completion
- 2 Aug 2017 (actual)
- Study completion
- 2 Aug 2017 (actual)
- First posted
- 7 Aug 2017 (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 study designed to evaluate vascular changes after radical laparoscopic prostatectomy using Doppler ultrasound and the impact of such changes on erectile function and quality of life of patients. The baseline study will be compared with the study one year after surgery.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group #1 | – | Diagnostic Test: Doppler ultrasoundPatients with prostate cancer who will undergo radical prostatectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients with prostate cancer who underwent laparoscopic radical prostatectomy
Key inclusion criteria (1 listed)
- Male patients with prostate cancer who underwent laparoscopic radical prostatectomy
Key exclusion criteria (2 listed)
- Patients who were not interested in their sexual function and refused to perform this study
- Patients who required adjuvant or salvage treatment for their prostate cancer (radiation therapy, chemotherapy or androgen deprivation therapy) during 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 |
|---|---|---|
| Doppler ultrasoundBasal Doppler ultrasound and Doppler ultrasound one year after radical prostatectomy | Diagnostic test | Group #1 |
Primary outcome
Left and right Cavernous artery diameter
Time frame: 1 year
mm
Left and right Systolic velocity cavernous artery
Time frame: 1 year
cm/s
Left and right Diastolyc velocity cavernous artery
Time frame: 1 year
cm/s
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 7 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Jesus Muñoz-Rodriguez, MD principal investigator
Corporació Sanitaria Parc Tauli
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms and Erectile Dysfunction Following Radical Prostatectomy, run by Corporacion Parc Tauli.
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 2 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 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Left and right Cavernous artery diameter (time frame: 1 year). The study lists 3 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 7 Aug 2017; AzTrials last refreshed its copy on 1 Nov 2026.