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Brain Activity Monitoring for Prostate Cancer Post-Surgery

N/A

Recruiting

Led By Khurshid A Guru

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults who undergo robot-assisted radical prostatectomy (RARP)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study Summary

This trial is investigating whether there are certain brain waves that are associated with being able to control the bladder after a radical prostatectomy.

Who is the study for?

This trial is for adults with prostate cancer who are able to control their bladder before surgery and will undergo robot-assisted radical prostatectomy. They must understand the study's experimental nature and agree to it by signing a consent form. Those unable or unwilling to follow the study plan, or deemed unsuitable by the investigator, cannot participate.Check my eligibility

What is being tested?

The trial studies brain activity (using EEG) and pelvic floor muscle activity (using EMG) in patients having robot-assisted surgery for prostate cancer. It aims to link specific brain waves with muscle control that affects bladder function post-surgery.See study design

What are the potential side effects?

Since this trial involves monitoring techniques like EEG and EMG rather than drug interventions, side effects are minimal but may include discomfort from electrode placement or skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult who will have or has had a robotic surgery for prostate cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

EEG measures obtained during urination.

Electroencephalography

Secondary outcome measures

EEG and EMG biofeedback

Improvement of continence

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive Care (brain and muscle monitoring, questionnaire)Experimental Treatment3 Interventions

Patients perform standard of care Kegel exercises while undergoing brain and muscle activity monitoring by EEG and EMG, respectively, before surgery, 6 weeks after surgery, and at 3, 6, and 12 months after surgery. Patients complete questionnaires over 5-10 minutes about urinary function

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Electroencephalography

2013

N/A

~790

Electromyography

2018

N/A

~210

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

30,758 Total Patients Enrolled

19 Trials studying Prostate Cancer

536 Patients Enrolled for Prostate Cancer

Khurshid A GuruPrincipal InvestigatorRoswell Park Cancer Institute

2 Previous Clinical Trials

117 Total Patients Enrolled

Media Library

Electroencephalography Clinical Trial Eligibility Overview. Trial Name: NCT04646434 — N/A

Prostate Cancer Research Study Groups: Supportive Care (brain and muscle monitoring, questionnaire)

Prostate Cancer Clinical Trial 2023: Electroencephalography Highlights & Side Effects. Trial Name: NCT04646434 — N/A

Electroencephalography 2023 Treatment Timeline for Medical Study. Trial Name: NCT04646434 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are partaking in the research project?

"Affirmative. Records from clinicaltrials.gov attest that the recruitment for this trial is ongoing, with its announcement going up on November 30th 2020 and last updated June 2nd 2022. A total of 100 patients are being enrolled in one medical centre."

Answered by AI

Are there any remaining vacancies for participants of this clinical trial?

"Affirmative. According to the clinicaltrials.gov website, this research project is currently recruiting participants. This trial was first posted on November 30th 2020 and underwent its most recent edit June 2nd 2022; it requires 100 volunteers from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Brain and Pelvic Floor Muscle Activity of Patients Undergoing Robot-Assisted Radical Prostatectomy

2023. "Brain and Pelvic Floor Muscle Activity of Patients Undergoing Robot-Assisted Radical Prostatectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04646434.