Stage I Prostate Cancer AJCC v8NCT04981834
Robot-Assisted Radical Prostatectomy With or Without Vesicopexy in Patients With Prostate Cancer
A study testing Quality-of-Life Assessment, Questionnaire Administration and Radical Prostatectomy in people with Stage I Prostate Cancer AJCC v8 and Stage II Prostate Cancer AJCC v8, run by University of Southern California at 1 site in United States.
Trial summary
This phase III trial compares the effects of robot-assisted radical prostatectomy (RARP) with or without vesicopexy on urinary continence (a person's ability to control their bladder) and quality of life in patients with cancer of the prostate. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8
- What is being tested?
- Quality-of-Life Assessment, Questionnaire Administration and Radical Prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2021to 31 Mar 2027
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with age > 18 years
- Prostate cancer patients undergoing RARP with anterior approach at University of Southern California (USC) urology
- Ability to understand and the willingness to sign a written informed consent
- Clinical stage < 4 and (M0) prostate cancer
- Eastern Cooperative Oncology Group (ECOG) performance score 0-1
- Pre-operative (op) urinary continence
- Negative history of pelvic radiation and/or previous local therapy for prostate cancer (i.e., radiation or focal therapy)
Who cannot join
- Any history of psychiatric, neurologic or cognitive disease
- Any history of neuropathic bladder
- Any drug or alcohol addiction
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: The Effect of Vesicopexy on Urinary Continence and Quality of Life Following Robotic-Assisted Radical Prostatectomy: A Phase III Randomized Clinical Trial
This phase III trial compares the effects of robot-assisted radical prostatectomy (RARP) with or without vesicopexy on urinary continence (a person's ability to control their bladder) and quality of life in patients with cancer of the prostate. RARP is the most adopted surgical approach for treatment of prostate cancer that has not spread to other places in the body (non-metastatic). Urinary incontinence (inability to control the bladder) is one of the most common complications of RARP, impacting patients' quality of life and psychological well-being. Different techniques have been proposed to improve urinary continence following RARP. Vesicopexy is one technique that restores the bladder to its normal position in the body after RARP. This study aims to evaluate whether RARP with vesicopexy may improve urinary continence and quality of life after surgery in prostate cancer patients.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the 3-month (+/- 3 weeks) urinary continence following RARP with or without vesicopexy.
SECONDARY OBJECTIVES:
- To evaluate the 3-month (+/- 3 weeks) quality of life following RARP with or without vesicopexy.
II. To evaluate the 72-hour post-operative (postop) urinary continence following RARP with or without vesicopexy.
III. To evaluate the 1-month (+/- 1 week) postop urinary continence following RARP with or without vesicopexy.
IV. To evaluate sexual function at 3-month (+/- 3 weeks) following RARP with or without vesicopexy.
- To evaluate the operative time in patients undergoing RARP with or without vesicopexy.
VI. To evaluate intraoperative complications in patients undergoing RARP with or without vesicopexy.
VII. To evaluate 90-day post-operative complications in patients undergoing RARP with or without vesicopexy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
ARM II: Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
After study completion, patients will be followed-up with at 24 hours, 1-month, and 3-months.
- Conditions
- Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration, Radical Prostatectomy, Vesicopexy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Radical ProstatectomyProcedure or surgery
Also called Prostatovesiculectomy
Undergo RARP
VesicopexyProcedure or surgery
Also called Cystopexy, Vesicofixation
Undergo vesicopexy
| Study group | Role | What they receive |
|---|---|---|
| Arm I (radical prostatectomy, vesicopexy) | Experimental | Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Radical Prostatectomy; Procedure: Vesicopexy |
| Arm II (radical prostatectomy) | Active comparator | Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month (+/- 3 weeks) urinary continence rate following RARP with or without vesicopexy
Defined continence as 0-1 safety pad usage. Use the "pictorial pad usage questionnaire."
Measured: 3 months post-operative
Secondary outcomes (7)
3-month (+/- 3 weeks) quality of life following surgery
Use the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ-PR25).
Measured: 3 months post-operative
72-hour postop urinary continence following surgery
Defined continence as 0-1 safety pad usage. Assessed with the "pictorial pad usage questionnaire."
Measured: 72 hours post-operative
1-month (+/- 1 week) post-operative urinary continence following surgery
Defined continence as 0-1 safety pad usage. Assessed with the "pictorial pad usage questionnaire."
Measured: 1 month post-operative
Sexual function at 3-month (+/- 3 weeks) following surgery
Sexual Health Inventory for Men (SHIM) questionnaire is used for the evaluation of sexual function.
Measured: 3 months post-operative
Operative time
Measured: Duration of operation
Intra-operative complications
Measured: Duration of operation
90-day post-operative complications
Measured: 90 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start27 Oct 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Why it stopped: Accrual goal reached and suspended for analysis purposes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Prostate Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hooman Djaladat, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981834
- Sponsor's protocol ID
- 4P-21-1
- Other IDs
- NCI-2021-05989, 4P-21-1, P30CA014089
- Status last verified
- May 2026
- First submitted
- 27 Jul 2021
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vesicopexy on Urinary Continence and Quality of Life Following Robotic-Assisted Radical Prostatectomy: A Phase III Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04981834
- Acronym / sponsor ID
- 4P-21-1
- Conditions
- Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Accrual goal reached and suspended for analysis purposes.
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 29 Jul 2021 (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.
This phase III trial compares the effects of robot-assisted radical prostatectomy (RARP) with or without vesicopexy on urinary continence (a person's ability to control their bladder) and quality of life in patients with cancer of the prostate. RARP is the most adopted surgical approach for treatment of prostate cancer that has not spread to other places in the body (non-metastatic). Urinary incontinence (inability to control the bladder) is one of the most common complications of RARP, impacting patients' quality of life and psychological well-being. Different techniques have been proposed to improve urinary continence following RARP. Vesicopexy is one technique that restores the bladder to its normal position in the body after RARP. This study aims to evaluate whether RARP with vesicopexy may improve urinary continence and quality of life after surgery in prostate cancer patients.
Detailed description
PRIMARY OBJECTIVE:
- To determine the 3-month (+/- 3 weeks) urinary continence following RARP with or without vesicopexy.
SECONDARY OBJECTIVES:
- To evaluate the 3-month (+/- 3 weeks) quality of life following RARP with or without vesicopexy.
II. To evaluate the 72-hour post-operative (postop) urinary continence following RARP with or without vesicopexy.
III. To evaluate the 1-month (+/- 1 week) postop urinary continence following RARP with or without vesicopexy.
IV. To evaluate sexual function at 3-month (+/- 3 weeks) following RARP with or without vesicopexy.
- To evaluate the operative time in patients undergoing RARP with or without vesicopexy.
VI. To evaluate intraoperative complications in patients undergoing RARP with or without vesicopexy.
VII. To evaluate 90-day post-operative complications in patients undergoing RARP with or without vesicopexy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
ARM II: Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
After study completion, patients will be followed-up with at 24 hours, 1-month, and 3-months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (radical prostatectomy, vesicopexy) | Experimental | Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Radical Prostatectomy, Procedure: VesicopexyPatients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion. |
| Arm II (radical prostatectomy) | Active comparator | Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Radical ProstatectomyPatients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men with age > 18 years
- Prostate cancer patients undergoing RARP with anterior approach at University of Southern California (USC) urology
- Ability to understand and the willingness to sign a written informed consent
- Clinical stage < 4 and (M0) prostate cancer
- Eastern Cooperative Oncology Group (ECOG) performance score 0-1
Key exclusion criteria (3 listed)
- Any history of psychiatric, neurologic or cognitive disease
- Any history of neuropathic bladder
- Any drug or alcohol addiction
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 |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (radical prostatectomy, vesicopexy), Arm II (radical prostatectomy) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (radical prostatectomy, vesicopexy), Arm II (radical prostatectomy) |
| Radical ProstatectomyAlso: ProstatovesiculectomyUndergo RARP | Procedure or surgery | Arm I (radical prostatectomy, vesicopexy), Arm II (radical prostatectomy) |
| VesicopexyAlso: Cystopexy, VesicofixationUndergo vesicopexy | Procedure or surgery | Arm I (radical prostatectomy, vesicopexy) |
Primary outcome
3-month (+/- 3 weeks) urinary continence rate following RARP with or without vesicopexy
Time frame: 3 months post-operative
Defined continence as 0-1 safety pad usage. Use the "pictorial pad usage questionnaire."
7 secondary outcomes
3-month (+/- 3 weeks) quality of life following surgery
Time frame: 3 months post-operative
72-hour postop urinary continence following surgery
Time frame: 72 hours post-operative
1-month (+/- 1 week) post-operative urinary continence following surgery
Time frame: 1 month post-operative
Sexual function at 3-month (+/- 3 weeks) following surgery
Time frame: 3 months post-operative
Operative time
Time frame: Duration of operation
Intra-operative complications
Time frame: Duration of operation
90-day post-operative complications
Time frame: 90 days post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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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.
Hooman Djaladat, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality-of-Life Assessment, Questionnaire Administration and Radical Prostatectomy in people with Stage I Prostate Cancer AJCC v8 and Stage II Prostate Cancer AJCC v8, run by University of Southern California at 1 site in United States.
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 7 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: paused, as of the sponsor's last update on 1 Jun 2026. 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 United States. 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?
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?
3-month (+/- 3 weeks) urinary continence rate following RARP with or without vesicopexy (time frame: 3 months post-operative). 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 1 Jun 2026.