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Robotic Surgery for Prostate Cancer

N/A
Recruiting
Led By Hooman Djaladat, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Negative history of pelvic radiation and/or previous local therapy for prostate cancer (i.e., radiation or focal therapy)
Prostate cancer patients undergoing RARP with anterior approach at University of Southern California (USC) urology
Must not have
Any history of neuropathic bladder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-operative
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing the effects of two different surgeries for prostate cancer on patients' ability to control their bladder and quality of life.

Who is the study for?
This trial is for men over 18 with non-metastatic prostate cancer who are undergoing robot-assisted surgery at USC urology. They must be able to consent, have a good performance status (ECOG score 0-1), and control their bladder before the operation. Men with psychiatric, neurological conditions, neuropathic bladder issues, or substance addictions cannot participate.
What is being tested?
The study compares two surgical methods: robot-assisted radical prostatectomy alone versus the same procedure with an additional technique called vesicopexy. The goal is to see if adding vesicopexy improves bladder control and quality of life after surgery for prostate cancer patients.
What are the potential side effects?
Potential side effects include difficulties in controlling the bladder (urinary incontinence) which can affect psychological well-being and overall quality of life. Specific side effects from vesicopexy are not detailed but may involve typical surgical risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never had radiation or local therapy for prostate cancer.
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I am a prostate cancer patient scheduled for RARP with an anterior approach at USC.
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My prostate cancer is in an early stage and has not spread.
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I am a man over 18 years old.
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I am fully active or can carry out light work.
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I was able to control my bladder before surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of bladder nerve damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
3-month (+/- 3 weeks) urinary continence rate following RARP with or without vesicopexy
Secondary study objectives
1-month (+/- 1 week) post-operative urinary continence following surgery
3-month (+/- 3 weeks) quality of life following surgery
72-hour postop urinary continence following surgery
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (radical prostatectomy, vesicopexy)Experimental Treatment4 Interventions
Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
Group II: Arm II (radical prostatectomy)Active Control3 Interventions
Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radical Prostatectomy
2005
Completed Phase 2
~4550

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
942 Previous Clinical Trials
1,604,360 Total Patients Enrolled
18 Trials studying Prostate Cancer
9,422 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,887 Previous Clinical Trials
41,020,841 Total Patients Enrolled
569 Trials studying Prostate Cancer
529,860 Patients Enrolled for Prostate Cancer
Hooman Djaladat, MDPrincipal InvestigatorUniversity of Southern California
1 Previous Clinical Trials
24 Total Patients Enrolled

Media Library

Radical Prostatectomy Clinical Trial Eligibility Overview. Trial Name: NCT04981834 — N/A
Prostate Cancer Research Study Groups: Arm I (radical prostatectomy, vesicopexy), Arm II (radical prostatectomy)
Prostate Cancer Clinical Trial 2023: Radical Prostatectomy Highlights & Side Effects. Trial Name: NCT04981834 — N/A
Radical Prostatectomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04981834 — N/A
~49 spots leftby Oct 2025
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