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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post-operative

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

0 / 7Eligibility criteria met