Cancer of ProstateNCT05224024
Retzius-sparing Technique in Robotic-assisted Radical Prostatectomy
A study testing Retzius-repairing robot-assisted radical prostatectomy in people with Cancer of Prostate and Prostate Adenocarcinoma, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this study is to compare the short-term and 1-yr follow-up functional outcomes of retzius-repairing robot-assisted radical prostatectomy (RR-RARP) with retzius-sparing (RS) RARP. This study is a single-centre, single-surgeon and a prospective randomized study. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Cancer of Prostate, Prostate Adenocarcinoma, Urinary Incontinence,Stress
- What is being tested?
- Retzius-repairing robot-assisted radical prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2022to 31 Dec 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Prostate cancer patients,
- Life expectancy > 10 years,
- Clinically organ confined disease (cT1-cT2),
- Biopsy Gleason score ≤ 7,
- Total serum PSA ≤ 10 ng/ml,
- Normal preoperative continence and potency.
Who cannot join
- Pre-existing urinary incontinence,
- Any previous prostatic, urethral, bladder neck surgery,
- Neoadjuvant therapy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University Faculty of Medicine Urology Department
Ankara, Altındag, 06850
Eralp Kubilay, 05310231323, eralpkubi@gmail.com
About this study
Official title: Retzius-sparing Versus Retzius-repairing Robotic-assisted Radical Prostatectomy: A Prospective Randomized Comparison on Functional Outcomes With a 1-year Follow-up
The objective of this study is to compare the short-term and 1-yr follow-up functional outcomes of retzius-repairing robot-assisted radical prostatectomy (RR-RARP) with retzius-sparing (RS) RARP.
This study is a single-centre, single-surgeon and a prospective randomized study.
Read the detailed description
Radical prostatectomy (RP) is the standard treatment method widely used in clinically localized and locally advanced prostate cancer (PCa). The main purpose of RP is to completely remove the tumor tissue and to provide the best oncological result and as well as recovery postoperative urinary continence and erectile functions. Depending on the severity of urinary leakage, incontinence is one of the important complications that seriously affect the quality of life after RP. Robot-assisted radical prostatectomy (RARP) has become a frequently preferred surgical treatment in PCa since the early 2000s. The effort to improve functional results has led to the continuous development and evolution of the robotic technique and different approaches have been tried to achieve the best. However, no sufficient evidence was found to show the superiority of any approach. In standard RARP, there may be a risk of deterioration of anatomical structures that contribute to the urinary continence (UC) mechanism due to the need for access to the retzius space. For this purpose, in 2010, Galfano et al. described a surgical technique performed through the douglas space in RP that preserves the retzius and the structures involved in the continence mechanism. With this technique, it is aimed to provide early recovery in UC and erectile functions after surgery by protecting the retzius. In the first case series of 200 patients, it was reported that an early UC was achieved in more than 90% of the patients. In addition, it was supported by other studies that early UC recovery rates are higher with the retzius-sparing (RS) technique, and in some series, immediate UC rates at the catheter removal were reported to be higher in the RS technique. However, it was stated that there was no significant difference in 1-year results between the standard technique and the RS technique. When the current literature is reviewed, the early continence advantages of the RS technique compared to the standard technique are emphasized. On the other hand, most surgeons still have not abandoned the standard technique, and a recent questionnaire of 250 participants showed that only 11% of RARP was performed using the RS-RALP approach. Although various continence preserving techniques have been tried in the standard RARP procedure, the high quality evidence for these techniques in the literature is limited.
The focus of our study is lack of a randomized prospective study comparing the modified reconstructive anterior approach, which we define as retzius-repairing (RR), and the RS technique in the evaluation of postoperative functional outcomes. Differ from the current literature, we aim of this study is to evaluate the results of a single surgeon prospective randomized comparative study on functional outcomes at 1-year follow-up between RR-RALP and RS-RALP for clinically localized PCa treatment.
This prospective randomized study has planned to carried out between June 2021 and December 2021, after achieving the ethics committee approval. Eligible patients were randomized in a 1:1 allocation ratio and 80 consecutive patients with clinically localized PCa underwent RALP by retzius-repairing (40 patients ) and retzius-sparing (40 patients) approach by a single surgeon (KT) and surgical team at a tertiary care institution (Ankara University School of Medicine), according to a parallel design. The assignment of each patient to the first or second treatment group was randomized with a computer-based randomization table. The UC recovery rates will be evaluated at the catheter removal, and subsequently at 1, 6 and 12 months after surgery. Postoperative potency will be eveluated at 3 and 12 months after surgeries. Other outcomes are the comparisons of postoperative complication rates, positive surgical margin and 1 year oncological outcomes.
- Conditions
- Cancer of Prostate, Prostate Adenocarcinoma, Urinary Incontinence,Stress, Erectile Dysfunction Following Radical Prostatectomy
- Being tested
- Retzius-repairing robot-assisted radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retzius-repairing robot-assisted radical prostatectomyProcedure or surgery
Also called Retzius-sparing robot-assisted radical prostatectomy
Repairing the retzius space which is opened during the standard robot assisted radical prostatectomy.
| Study group | Role | What they receive |
|---|---|---|
| Retzius-repairing robot-assisted radical prostatectomy group | Active comparator | This group is randomized to operated with retzius-repairing technique as prostate cancer patients with robot assisted radical prostatectomy. Receives: Procedure: Retzius-repairing robot-assisted radical prostatectomy |
| Retzius-sparing robot-assisted radical prostatectomy group | Placebo comparator | This group is randomized to operated with retzius-sparing technique as prostate cancer patients with robot assisted radical prostatectomy. Receives: Procedure: Retzius-repairing robot-assisted radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Outcomes-Urinary Incontinance 1st week
Compare two surgical technique in terms of urinary incontinence. For URINARY INCONTINANCE;
1st week evaluation: The percentage of patients with Immediate urinary continence defined as 1 safety or no pad within 1 week of catheter removal will be compared.
Measured: 1 week
Functional Outcomes-Urinary Incontinance 4th week
Compare two surgical technique in terms of urinary incontinence. For URINARY INCONTINANCE; 4th week evaluation will be done with International Consultation on Urinary Incontinence on Male Lower Urinary Tract Symptoms questionaire.
Measured: 4 week
Functional Outcomes-Urinary Incontinance 6th month
Compare two surgical technique in terms of urinary incontinence. For URINARY INCONTINANCE; 6th month evaluation will be done with International Consultation on Urinary Incontinence on Male Lower Urinary Tract Symptoms questionaire.
Measured: 6 month
Functional Outcomes-Urinary Incontinance 1st year
Compare two surgical technique in terms of urinary incontinence. For URINARY INCONTINANCE;
1st year evaluation will be done with International Consultation on Urinary Incontinence on Male Lower Urinary Tract Symptoms questionaire.
Measured: 1 year
Functional Outcomes-Erectile Dysfunction 4th week
For ERECTILE DYSFUNCTION; 4th week evaluation: The percentage pf patient with Immediate potency defined as erections sufficient for intercourse within the first month after surgery will be compared.
Measured: 4 week
Functional Outcomes-Erectile Dysfunction 6th month
For ERECTILE DYSFUNCTION; 6th month evaluation will be done with International Index of Erectile Function-5 questionaire.
Measured: 6 month
Functional Outcomes-Erectile Dysfunction 1st year
For ERECTILE DYSFUNCTION;
1st year evaluation will be done with International Index of Erectile Function-5 questionaire.
Measured: 1 year
Oncological Outcomes
Comparison of surgical margin positivity from pathological reports between two surgery groups.
The percentage of partients with surgical margin positivity will be compared according to pathological investigation.
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 posted4 Feb 2022
- Study start15 Feb 2022 (estimated)
- Primary completion30 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cancer of ProstateStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eralp Kubilay, Ankara University
- Investigators
- Eralp Kubilay, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224024
- Sponsor's protocol ID
- ANKUNI641991
- Status last verified
- Jan 2022
- First submitted
- 21 Dec 2021
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Galfano A, Ascione A, Grimaldi S, Petralia G, Strada E, Bocciardi AM. A new anatomic approach for robot-assisted laparoscopic prostatectomy: a feasibility study for completely intrafascial surgery. Eur Urol. 2010 Sep;58(3):457-61. doi: 10.1016/j.eururo.2010.06.008. Epub 2010 Jun 16.
PubMed 20566236Galfano A, Di Trapani D, Sozzi F, Strada E, Petralia G, Bramerio M, Ascione A, Gambacorta M, Bocciardi AM. Beyond the learning curve of the Retzius-sparing approach for robot-assisted laparoscopic radical prostatectomy: oncologic and functional results of the first 200 patients with >/= 1 year of follow-up. Eur Urol. 2013 Dec;64(6):974-80. doi: 10.1016/j.eururo.2013.06.046. Epub 2013 Jul 8.
PubMed 23856036Galfano A, Panarello D, Secco S, Di Trapani D, Barbieri M, Napoli G, Strada E, Petralia G, Bocciardi AM. Does prostate volume have an impact on the functional and oncological results of Retzius-sparing robot-assisted radical prostatectomy? Minerva Urol Nefrol. 2018 Aug;70(4):408-413. doi: 10.23736/S0393-2249.18.03069-2. Epub 2018 Mar 28.
PubMed 29595042van der Poel HG, de Blok W, Joshi N, van Muilekom E. Preservation of lateral prostatic fascia is associated with urine continence after robotic-assisted prostatectomy. Eur Urol. 2009 Apr;55(4):892-900. doi: 10.1016/j.eururo.2009.01.021. Epub 2009 Jan 21.
PubMed 19171418
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retzius-sparing Versus Retzius-repairing Robotic-assisted Radical Prostatectomy: A Prospective Randomized Comparison on Functional Outcomes With a 1-year Follow-up
- ClinicalTrials.gov ID
- NCT05224024
- Acronym / sponsor ID
- ANKUNI641991
- Conditions
- Cancer of Prostate, Prostate Adenocarcinoma, Urinary Incontinence,Stress, Erectile Dysfunction Following Radical Prostatectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (estimated)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 Feb 2022 (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.
The objective of this study is to compare the short-term and 1-yr follow-up functional outcomes of retzius-repairing robot-assisted radical prostatectomy (RR-RARP) with retzius-sparing (RS) RARP.
This study is a single-centre, single-surgeon and a prospective randomized study.
Detailed description
Radical prostatectomy (RP) is the standard treatment method widely used in clinically localized and locally advanced prostate cancer (PCa). The main purpose of RP is to completely remove the tumor tissue and to provide the best oncological result and as well as recovery postoperative urinary continence and erectile functions. Depending on the severity of urinary leakage, incontinence is one of the important complications that seriously affect the quality of life after RP. Robot-assisted radical prostatectomy (RARP) has become a frequently preferred surgical treatment in PCa since the early 2000s. The effort to improve functional results has led to the continuous development and evolution of the robotic technique and different approaches have been tried to achieve the best. However, no sufficient evidence was found to show the superiority of any approach. In standard RARP, there may be a risk of deterioration of anatomical structures that contribute to the urinary continence (UC) mechanism due to the need for access to the retzius space. For this purpose, in 2010, Galfano et al. described a surgical technique performed through the douglas space in RP that preserves the retzius and the structures involved in the continence mechanism. With this technique, it is aimed to provide early recovery in UC and erectile functions after surgery by protecting the retzius. In the first case series of 200 patients, it was reported that an early UC was achieved in more than 90% of the patients. In addition, it was supported by other studies that early UC recovery rates are higher with the retzius-sparing (RS) technique, and in some series, immediate UC rates at the catheter removal were reported to be higher in the RS technique. However, it was stated that there was no significant difference in 1-year results between the standard technique and the RS technique. When the current literature is reviewed, the early continence advantages of the RS technique compared to the standard technique are emphasized. On the other hand, most surgeons still have not abandoned the standard technique, and a recent questionnaire of 250 participants showed that only 11% of RARP was performed using the RS-RALP approach. Although various continence preserving techniques have been tried in the standard RARP procedure, the high quality evidence for these techniques in the literature is limited.
The focus of our study is lack of a randomized prospective study comparing the modified reconstructive anterior approach, which we define as retzius-repairing (RR), and the RS technique in the evaluation of postoperative functional outcomes. Differ from the current literature, we aim of this study is to evaluate the results of a single surgeon prospective randomized comparative study on functional outcomes at 1-year follow-up between RR-RALP and RS-RALP for clinically localized PCa treatment.
This prospective randomized study has planned to carried out between June 2021 and December 2021, after achieving the ethics committee approval. Eligible patients were randomized in a 1:1 allocation ratio and 80 consecutive patients with clinically localized PCa underwent RALP by retzius-repairing (40 patients ) and retzius-sparing (40 patients) approach by a single surgeon (KT) and surgical team at a tertiary care institution (Ankara University School of Medicine), according to a parallel design. The assignment of each patient to the first or second treatment group was randomized with a computer-based randomization table. The UC recovery rates will be evaluated at the catheter removal, and subsequently at 1, 6 and 12 months after surgery. Postoperative potency will be eveluated at 3 and 12 months after surgeries. Other outcomes are the comparisons of postoperative complication rates, positive surgical margin and 1 year oncological outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retzius-repairing robot-assisted radical prostatectomy group | Active comparator | Procedure: Retzius-repairing robot-assisted radical prostatectomyThis group is randomized to operated with retzius-repairing technique as prostate cancer patients with robot assisted radical prostatectomy. |
| Retzius-sparing robot-assisted radical prostatectomy group | Placebo comparator | Procedure: Retzius-repairing robot-assisted radical prostatectomyThis group is randomized to operated with retzius-sparing technique as prostate cancer patients with robot assisted radical prostatectomy. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Prostate cancer patients,
- Life expectancy > 10 years,
- Clinically organ confined disease (cT1-cT2),
- Biopsy Gleason score ≤ 7,
- Total serum PSA ≤ 10 ng/ml,
Key exclusion criteria (3 listed)
- Pre-existing urinary incontinence,
- Any previous prostatic, urethral, bladder neck surgery,
- Neoadjuvant therapy.
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 |
|---|---|---|
| Retzius-repairing robot-assisted radical prostatectomyAlso: Retzius-sparing robot-assisted radical prostatectomyRepairing the retzius space which is opened during the standard robot assisted radical prostatectomy. | Procedure or surgery | Retzius-repairing robot-assisted radical prostatectomy group, Retzius-sparing robot-assisted radical prostatectomy group |
Primary outcome
Functional Outcomes-Urinary Incontinance 1st week
Time frame: 1 week
Compare two surgical technique in terms of urinary incontinence. For URINARY INCONTINANCE; 1st week evaluation: The percentage of patients with Immediate urinary continence defined as 1 safety or no pad within 1 week of catheter removal will be compared.
Functional Outcomes-Urinary Incontinance 4th week
Time frame: 4 week
Compare two surgical technique in terms of urinary incontinence. For URINARY INCONTINANCE; 4th week evaluation will be done with International Consultation on Urinary Incontinence on Male Lower Urinary Tract Symptoms questionaire.
Functional Outcomes-Urinary Incontinance 6th month
Time frame: 6 month
Compare two surgical technique in terms of urinary incontinence. For URINARY INCONTINANCE; 6th month evaluation will be done with International Consultation on Urinary Incontinence on Male Lower Urinary Tract Symptoms questionaire.
Functional Outcomes-Urinary Incontinance 1st year
Time frame: 1 year
Compare two surgical technique in terms of urinary incontinence. For URINARY INCONTINANCE; 1st year evaluation will be done with International Consultation on Urinary Incontinence on Male Lower Urinary Tract Symptoms questionaire.
Functional Outcomes-Erectile Dysfunction 4th week
Time frame: 4 week
For ERECTILE DYSFUNCTION; 4th week evaluation: The percentage pf patient with Immediate potency defined as erections sufficient for intercourse within the first month after surgery will be compared.
Functional Outcomes-Erectile Dysfunction 6th month
Time frame: 6 month
For ERECTILE DYSFUNCTION; 6th month evaluation will be done with International Index of Erectile Function-5 questionaire.
Functional Outcomes-Erectile Dysfunction 1st year
Time frame: 1 year
For ERECTILE DYSFUNCTION; 1st year evaluation will be done with International Index of Erectile Function-5 questionaire.
Oncological Outcomes
Time frame: 1 year
Comparison of surgical margin positivity from pathological reports between two surgery groups. The percentage of partients with surgical margin positivity will be compared according to pathological investigation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Results publication: PubMed 20566236Galfano A, Ascione A, Grimaldi S, Petralia G, Strada E, Bocciardi AM. A new anatomic approach for robot-assisted laparoscopic prostatectomy: a feasibility study for completely intrafascial surgery. Eur Urol. 2010 Sep;58(3):457-61. doi: 10.1016/j.eururo.2010.06.008. Epub 2010 Jun 16.
- Results publication: PubMed 23856036Galfano A, Di Trapani D, Sozzi F, Strada E, Petralia G, Bramerio M, Ascione A, Gambacorta M, Bocciardi AM. Beyond the learning curve of the Retzius-sparing approach for robot-assisted laparoscopic radical prostatectomy: oncologic and functional results of the first 200 patients with >/= 1 year of follow-up. Eur Urol. 2013 Dec;64(6):974-80. doi: 10.1016/j.eururo.2013.06.046. Epub 2013 Jul 8.
- Results publication: PubMed 29595042Galfano A, Panarello D, Secco S, Di Trapani D, Barbieri M, Napoli G, Strada E, Petralia G, Bocciardi AM. Does prostate volume have an impact on the functional and oncological results of Retzius-sparing robot-assisted radical prostatectomy? Minerva Urol Nefrol. 2018 Aug;70(4):408-413. doi: 10.23736/S0393-2249.18.03069-2. Epub 2018 Mar 28.
- Results publication: PubMed 19171418van der Poel HG, de Blok W, Joshi N, van Muilekom E. Preservation of lateral prostatic fascia is associated with urine continence after robotic-assisted prostatectomy. Eur Urol. 2009 Apr;55(4):892-900. doi: 10.1016/j.eururo.2009.01.021. Epub 2009 Jan 21.
- 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.
Eralp Kubilay principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retzius-repairing robot-assisted radical prostatectomy in people with Cancer of Prostate and Prostate Adenocarcinoma, run by Ankara University at 1 site in Turkey (Türkiye).
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 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 4 Feb 2022. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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 Eralp Kubilay (+905310231323, eralpkubi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Outcomes-Urinary Incontinance 1st week (time frame: 1 week). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05224024, which also lists 4 linked publications.
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 Feb 2022.