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

Trial Summary

What is the purpose of this trial?

This trial investigates brain and pelvic floor muscle activity in patients undergoing robot-assisted radical prostatectomy. This trial may help identify the brain waves that are associated with muscles involved in giving patients control over the bladder.

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.

Is brain activity monitoring safe for humans?

The research articles provided do not contain specific safety data for brain activity monitoring methods like EEG or EMG in humans. However, these methods are generally considered safe and non-invasive, as they involve monitoring electrical activity in the brain or muscles without causing harm. ^{1 2 3 4 5}

How does the treatment in the Brain Activity Monitoring for Prostate Cancer Post-Surgery trial differ from other treatments for prostate cancer?

This treatment is unique because it involves monitoring brain activity to potentially improve outcomes after prostate cancer surgery, focusing on preserving sexual and urinary function by enhancing nerve mapping techniques during surgery. ^{6 7 8 9 10}

Research Team

Khurshid A. Guru

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

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]

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]

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 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]

References

1. England 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of data capture for patient-reported toxicity following radiotherapy for prostate or cervical cancer. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The use of PRO in adverse event identification during cancer therapy - choosing the right questions to ask. [2019]

4. England 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. [2018]

5. Canada 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Novel Mapping Method for the Intraoperative Neurophysiologic Monitoring of Sexual Function During Prostate Surgery. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Improving the evaluation and diagnosis of clinically significant prostate cancer in 2017. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Intraoperative electrophysiological confirmation of neurovascular bundle preservation during radical prostatectomy: long-term assessment of urinary and sexual function. [2006]

9. United States pubmed.ncbi.nlm.nih.gov

Differences in sexual function and quality of life after nerve sparing and nonnerve sparing radical retropubic prostatectomy. [2015]

10. United States 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. [2021]