Brain Activity Monitoring for Prostate Cancer Post-Surgery

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Unwilling to follow protocol, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the brain and pelvic floor muscles coordinate during bladder control in patients who have undergone robot-assisted prostate surgery. By monitoring brain waves (using electroencephalography) and muscle activity before and after surgery, researchers aim to identify patterns that might improve recovery and bladder control. Participants will perform Kegel exercises while their brain and muscle activities are monitored, and they will complete a short questionnaire about urinary function. This trial suits those who have had or will have robot-assisted prostate surgery and have normal bladder control before the surgery. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance recovery strategies for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What prior data suggests that brain and muscle activity monitoring is safe for patients undergoing prostate cancer surgery?

Research has shown that EEG, a method for checking brain activity, is safe and usually causes little to no side effects, making it generally easy for people to handle.

Similarly, studies have indicated that EMG, which checks muscle activity, is also safe and well-tolerated, with serious side effects being rare.

Lastly, the questionnaires used in clinical studies have been tested for safety. They gather information about participants' health and recovery to help understand how the treatment works.

In summary, the methods used in this trial—monitoring brain and muscle activity with EEG and EMG, and filling out questionnaires—are all safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to monitor brain and muscle activity in prostate cancer patients post-surgery, which could lead to enhanced recovery methods. Unlike traditional treatments that focus solely on physical exercises like Kegel exercises to improve urinary function, this approach integrates brain and muscle monitoring through electroencephalography (EEG) and electromyography (EMG). By capturing detailed brain and muscle activity data before and after surgery, this method may uncover insights into how these systems interact during recovery, potentially leading to more personalized and effective rehabilitation strategies. Additionally, the use of questionnaires helps gauge patients' subjective experiences, providing a comprehensive view of recovery beyond physical metrics.

What evidence suggests that this trial's methods could be effective for monitoring brain and muscle activity in prostate cancer post-surgery?

In this trial, participants will undergo brain and muscle activity monitoring using electroencephalography (EEG) and electromyography (EMG), alongside completing questionnaires. Research has shown that EEG effectively identifies nerve responses during prostate surgery, achieving a high success rate of 91.6% in a previous study. This method reveals which nerves are active and how they control muscles. EMG assesses how well muscles and nerves work together, crucial for bladder control. Studies indicate that EMG provides valuable insights into muscle and nerve function. Questionnaires track quality of life and symptoms after prostate surgery, monitoring patient concerns like urinary incontinence over time. Together, these methods aim to enhance understanding of muscle control after surgery, leading to better patient outcomes. ^{1 2 6 7 8}

Who Is on the Research Team?

Khurshid A. Guru

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Must be continent preoperatively

Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

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

Exclusion Criteria

Unwilling or unable to follow protocol requirements

Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Monitoring

Participants perform Kegel exercises while undergoing brain and muscle activity monitoring by EEG and EMG before surgery.

1-2 weeks

1 visit (in-person)

Post-Surgery Monitoring

Participants perform Kegel exercises while undergoing brain and muscle activity monitoring by EEG and EMG at 6 weeks, 3 months, and 6 months after surgery.

6 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including continence improvement and EEG/EMG biofeedback.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electroencephalography
• Electromyography
• Questionnaire Administration

Trial Overview

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.

How Is the Trial Designed?

Group I: Supportive Care (brain and muscle monitoring, questionnaire) Experimental Treatment 4 Interventions

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

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Published Research Related to This Trial

In the ProtecT trial involving 1643 men aged 50-69 with localized prostate cancer, baseline patient-reported outcome measures (PROMs) showed that urinary symptoms were common, with 22% experiencing nocturia, while bowel symptoms were rare, indicating a need for monitoring urinary health in this population.

One-third of participants reported erectile dysfunction, with 16% indicating it was a moderate or large problem, highlighting the significant impact of prostate cancer on sexual function, particularly in older men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life. Lane, A., Metcalfe, C., Young, GJ., et al.[2018]

In a study of 170 patients who underwent radical retropubic prostatectomy, those who had nerve sparing surgery reported significantly better sexual function and overall quality of life compared to those who had nonnerve sparing surgery.

Half of the patients in the nerve sparing group experienced spontaneous erectile activity, indicating a positive impact on sexual health, while nerve sparing did not affect urinary or bowel function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in sexual function and quality of life after nerve sparing and nonnerve sparing radical retropubic prostatectomy. Gralnek, D., Wessells, H., Cui, H., et al.[2015]

In a study of 12 prostate cancer patients, a revised technique for intraoperative cavernous nerve mapping showed a high positive response rate of 91.6% to nerve stimulation, indicating its potential effectiveness in preserving erectile function after surgery.

The study suggests that while this mapping technique can help locate functional nerves, it does not provide continuous monitoring of nerve function, highlighting the need for careful patient selection for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Mapping Method for the Intraoperative Neurophysiologic Monitoring of Sexual Function During Prostate Surgery. Martín-Palomeque, G., Cabañes-Martínez, L., de Blas Beorlegui, G., et al.[2018]

In a study of 726 patients who underwent radical prostatectomy, the presence of positive surgical margins (PSM) was found in 21.9% of cases, with higher rates in patients with more advanced cancer (46.8% in ≥pT3).

Bilateral nerve-sparing surgery was associated with a significantly higher risk of PSM compared to non-nerve-sparing approaches, and avoiding non-anterior-apex PSM on the non-nerve-sparing side was crucial for improving biochemical recurrence-free survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Nerve-Sparing Status on Positive Surgical Margin Location and Biochemical Recurrence in Patients with Prostate Cancer Post Radical Prostatectomy. Matsuda, Y., Narita, S., Okubo, T., et al.[2021]

A study involving 77 cancer patients (37 with gynaecological cancer and 40 with prostate cancer) found that both electronic and paper formats of patient-reported toxicity questionnaires yielded consistent and reliable results in measuring treatment-related side effects after radiotherapy.

Patients generally found both formats clear and easy to use, with nearly half having no preference, indicating that electronic data capture for reporting toxicity is feasible and acceptable in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of data capture for patient-reported toxicity following radiotherapy for prostate or cervical cancer. Farnell, DJ., Routledge, J., Hannon, R., et al.[2022]

Recent advances in prostate cancer diagnosis include various biomarkers and risk calculators that improve early detection beyond just using prostate-specific antigen (PSA) levels, although each method has its own strengths and weaknesses.

Multiparametric MRI (mpMRI) shows promise as a diagnostic tool, but it is not yet fully ready for widespread clinical use, highlighting the need for a cost-effective, multivariable risk assessment approach that combines clinical data and biomarkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the evaluation and diagnosis of clinically significant prostate cancer in 2017. Carlsson, SV., Roobol, MJ.[2023]

This systematic scoping review aims to identify the prevalence of neglected sexual side effects (NSSE) in men after early prostate cancer treatment, which may include issues like orgasm-associated incontinence and penile deformity.

The study will also explore the effectiveness of using questionnaires as a discreet method for diagnosing and screening these often unreported side effects, potentially leading to better recognition and treatment options for affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mapping the prevalence of the neglected sexual side effects after prostate cancer treatment and the questionnaires used in their screening: a scoping review protocol. Röscher, P., van Wyk, JM.[2021]

A systematic method was developed to create a Patient Reported Outcome (PRO) questionnaire specifically for monitoring adverse events in metastatic prostate cancer patients undergoing treatment, based on data from multiple sources including FDA and EMA summaries, clinical trials, and patient interviews.

The resulting questionnaire, which includes 25 symptoms and 46 questions, was found to be useful and acceptable by patients, indicating its potential effectiveness in capturing adverse event information during oncologic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of PRO in adverse event identification during cancer therapy - choosing the right questions to ask. Nissen, A., Bager, L., Pappot, H.[2019]

The NCI developed a software tool to collect patient-reported adverse events in clinical trials, which underwent iterative usability testing with 169 patients and 47 professionals to enhance its functionality.

Modifications based on user feedback improved the software's usability, leading to significant enhancements in task performance for professionals, indicating that the tool is now effectively used in multiple cancer clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Software for Administering the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events: Usability Study. Schoen, MW., Basch, E., Hudson, LL., et al.[2023]

In a study of 70 patients undergoing radical retropubic prostatectomy, those in the bilateral nerve-sparing group (BNS) showed significantly better urinary function at 3 months post-surgery compared to those in the non-nerve-sparing (NNS) and unilateral nerve-sparing (UNS) groups.

The BNS group also maintained better sexual function scores throughout the recovery period, indicating that intraoperative electrophysiological testing to confirm nerve preservation can lead to improved outcomes in both urinary and sexual function after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative electrophysiological confirmation of neurovascular bundle preservation during radical prostatectomy: long-term assessment of urinary and sexual function. Namiki, S., Terai, A., Nakagawa, H., et al.[2006]

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Brain and Pelvic Floor Muscle Activity of Patients Who Had ...

Patients perform standard of care Kegel exercises while undergoing brain and muscle activity monitoring by EEG and EMG and UDS, respectively, before surgery, 6 ...