Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

All Drugs and Chemicals

Hormones

Questionnaires taking 20 minutes to complete.

Questionnaire

Deborah A. Kuban, MD

The goal of this behavioral research study is to look at patients' quality of life after treatment or management for prostate cancer.

Questionnaires:

You will complete 2 questionnaires that will ask you questions about your quality of life, urinary, bowel, sexual function, and any side effects that you may be having. You will be asked about any medications you may be taking and any other medical conditions you may have. The questionnaires will take about 20 minutes to complete. You may complete the questionnaires at the clinic, have them mailed to you (return postage will be included), or be asked the questions over the phone.

If you are on active surveillance (checking for prostate cancer by routine blood draws and biopsy, without active treatment), you will fill out the questionnaires on the same schedule as those receiving treatment that does not involve hormones.

If you are receiving therapy that does not involve hormones, you will complete the questionnaires before you receive treatment.

If you are receiving hormone therapy, you will complete the questionnaires before beginning the hormone therapy and then again within 3 weeks before starting radiation.

For all participants, at 3 and 6 months after the treatment is completed, you will complete the questionnaires again. Starting 6 months after you finish treatment, you will complete the questionnaires every 6 months for 2 years. Starting 2 years after treatment, you will complete the questionnaires once a year for 3 years.

Length of Study:

All participants will be considered off-study once they have completed the last questionnaires. You will be taken off study early if you receive a second treatment for prostate cancer or if you decide to have treatment while on active surveillance.

This is an investigational study. Up to 1448 patients will be enrolled in this study. All will be enrolled at MD Anderson, MD Anderson Albuquerque, and MD Anderson Cooper.

Quality of Life Study for Prostate Cancer Patients

A Comprehensive, Multimodality Quality of Life Study for Prostate Cancer Patients

M.D. Anderson Cancer Center

Symptoms and General Pathology

Hypothermia

Body Temperature Changes

Use of Hypothermia Cooling device only in the operating room. Intervention is Hypothermia Cooling Device.

Use of hypothermia cooling device in the operating room and up to five hours after surgery is intervention.

UroCool

Thomas Ahlering, MD

Robotic assisted laparoscopic radical prostatectomy (RLP) has gained widespread acceptance as a standard treatment for clinically localized prostate cancer. Despite the enhanced visualization and precise dissection afforded by the robotic platform, two major comorbidities affect a significant number of men: incontinence and erectile function.

Urinary continence and erectile function

It is commonly believed that the most important factor affecting continence is preservation of the external urinary sphincter complex which lies just below the prostate. Trauma to the urethral tissue itself after it is transected from the prostate and damage to the autonomic nerves that control this sphincter may lead to sphincteric dysfunction. In addition, dissection of the bladder may lead to bladder irritability which also plays a role in incontinence. Surgical removal of the prostate also causes significant inflammatory damage to the pelvic floor which likely delays recovery of urinary continence. The same trauma issues apply to sexual function.

One possible method to protect the nerves and other tissues from operative trauma may be the use of local hypothermia (cold-ischemia) to the pelvis. Local tissue hypothermia using ice, ice slush, or cold irrigation has been safely and routinely used for decades in humans during brain, heart, and kidney surgery to minimize organ damage. Yet, this technique has never been applied to prostate surgery. We will accomplish local cooling of the pelvis using a cooling balloon inserted into the rectum. The cooling balloon is powered by an FDA approved cooling system developed by Innercool therapies. Temperatures of 57-86 degrees F (22+/-8 degrees C).

2. 1. Selection of the Patients From June 2002 to August 2015, a total of 1,503 patients underwent RARP. During this period, perioperative data, including postoperative functional outcomes, were prospectively collected using a customized database; our ethics committee approved the data collection. Erectile function was assessed using the sexual health profile for men (SHIM) score at 3, 9, 15, and 24 months and then annually after surgery, and the duration of pad-free continence recovery was asked by a non-physician third party. In our institution, RH was applied during RARP for all patients from February 2008 to March 2015 (consecutively between the 671st and 1459th cases). Among the recruited patients, 789 men (52.6%) underwent HP, leaving the other 711 (47.4%) as controls.

The inclusion criteria for this study were as follows: (1) bilateral nerve-sparing RARP (over 70%) and (2) a minimum follow-up of 15 months. The exclusion criteria were as follows: (1) men with a history of salvage radiation therapy, chemotherapy, or hormone therapy after RARP (n=98) and (2) the presence of a high-risk disease with an initial prostate-specific antigen (PSA) level over 20 ng/ml or biopsy Gleason score over 8, which may influence the refining surgical plane around the neurovascular bundle (NVB), thereby affecting the degrees of nerve-sparing strategy at the time of surgery (n=275). Further, (3) the initial 100 cases were excluded to avoid potential bias from the learning period. From a cohort of 1,503 patients, 59 (3.92%) men whose potency outcome within 15 months was not assessed were also excluded from the study. Finally, 930 patients were selected for the analysis; half of the procedures (n=466, 50.1%) were performed under RH and the remaining other half (n=464, 49.9%) as normothermal controls.

2. 2. Endpoints of the Study The primary endpoints of this study were the SHIM score and the rate of potency regain, which was defined as a SHIM score \>17 in the RH and control groups 15 months after surgery. Considering the proven impacts of age and preoperative SHIM scores on the recovery of potency, the groups were further divided into the young and potent (YP: age \<65 years and SHIM score ≥22, n=409, 43.9%) subgroup and susceptible for impotency (SI: age ≥65 years or SHIM score \<22, n=512, 55.1%) counterpart and investigated the sexual function of the YP subgroup. The secondary endpoints were the duration of pad-free continence regain and the rate of continence recovery within 3 months after surgery, especially in the YP subgroup.

2.3. Surgical Protocol for RH All procedures were performed by a single surgeon. RH was achieved by devising an endorectal cooling balloon system (ECB) as previously reported \[2, 4, 5\]. In brief, a 40-cm, 24-F, 3-way latex urethral catheter was placed inside a 5 × 2.5-inch elliptic latex balloon that distended at a low pressure and conformed to the rectal wall without excessive deformations. The lubricated ECB was inserted just inside the anus and anchored by inflating the catheter balloon to 20 ml. The ECB was then distended and cycled continuously with cold saline (4°C) by gravity 40 cm above the patient. The ECB volume was \~200 ml. A 9-F esophageal probe (Smiths Medical ASD, Rockland, MA) was used to obtain the intracorporeal temperature readings directly along the anterior surface of the rectum/NVB.

Use of Hypothermia During Robotic Prostatectomy

Hypothermic Nerve Sparing Radical Prostatectomy

The primary aim is confirmation of the feasibility and safety using an improved, more efficient and less labor intensive cooling balloon in patients undergoing hypothermic nerve-sparing RLP. Continence is defined as no protective urinary pad use as reported by the patient in response to the very first question on page 1 of the sample questionnaire.

University of California, Irvine

Adverse events were not broken by arm as both groups used the same device and underwent the same procedure leading to a large cohort of patients who underwent cooling. Adverse event reporting was irrespective of arm and cannot be separated. Adverse events were also assessed irrespective of terms.

Both arms:

An adverse event (AE) is any undesirable experience (sign, symptom, significant laboratory abnormality, illness, or other medical event) occurring to a patient that appears or worsens during a clinical study, regardless of etiology.

* Mild - Awareness of signs or symptoms that are easily tolerated. Signs and symptoms are transient and only of minor irritant type and cause no loss of time from normal activities; symptoms do not require medication or a medical evaluation.
* Moderate - Discomfort severe enough to cause interference with usual activities. Symptoms may require treatment but not extended hospitalization or intensive care for the patient.
* Severe - Incapacitating with inability to do work or usual activities. Signs and symptoms may be of systemic nature or require medical evaluation and/or treatment that requires prolonged hospital stay

General Adverse Events

Use of Hypothermia Cooling device only in the operating room

UroCool: Hypothermia Endorectal Device

Hypothermia Only OR

Use of hypothermia cooling device in the operating room and up to five hours after surgery.

UroCool: Hypothermia Endorectal Device

Hypothermia in OR + Recovery

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Linda Huynh

Feasibility and Safety Using an Improved, More Efficient and Less Labor Intensive Cooling Balloon in Patients Undergoing Hypothermic Nerve-sparing RLP in Participants Determined by Return to Continence

Overall Study

Erectile Dysfunction

Urinary Incontinence

Enuresis

Nocturnal Enuresis

Urination Disorders

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Lower Urinary Tract Symptoms

Urological Manifestations

Behavioral Symptoms

Elimination Disorders

Mental Disorders

Psychotic Disorders

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Patients that undergo robotic-assisted radical prostatectomy with the use intraoperative nerve monitoring, via electromyography, to identify the exact location of the somatic fibers in the pelvic nerves that seem crucial for urinary continence control and erectile function

Patients that undergo standard of care robotic-assisted radical prostatectomy.

Intraoperative nerve monitoring, via electromyography, enables real-time identification of the location of the somatic fibers in the pelvic nerves that seem crucial for urinary continence control and erectile function.

Intraoperative nerve monitoring,

With out the usage of intraoperative nerve monitoring

standard of care robotic-assisted radical prostatectomy

Jens Sønksen, Dr., Phd, MD

The purpose of this study is to evaluate whether the use of intraoperative nerve monitoring during robotic-assisted radical prostatectomy (RARP) can predict and improve post-surgery urinary continence and erectile function.

Study design:

This is a single center, randomized, single blinded, prospective, clinical trial. The study population will comprise of 100 men that will undergo either a non-nerve sparring or unilateral-nerve sparring RARP. This means that the preoperative evaluation has suggested that it will not be possible to preserve the cavernous parasympathetic nerves lying in the fascia on either side of the prostate gland during surgery (called bilateral-nerve sparring). Despite the term, non-nerve sparring surgery, the surgeon will still attempt to preserve the somatic fibers of the pudendal nerve as best possible. However, due to the extent of cancer tissue the surgeon will generally need to operate closer to the pudendal nerve then when performing bilateral-nerve sparring surgery. So, the somatic fibers of the pudendal nerve are more likely to be severed. The same is the case on one side when performing unilateral surgery.

The treatment group will consist of 50 subjects that will undergo nerve monitoring during RARP. Results will be compared to a control cohort consisting of 50 patients that will undergo contemporary RARP.

Aside from the usage of nerve monitoring in the intervention-group, all procedures and care from admission to the hospital through discharge will be standard of care for subjects in both the control and Intervention-group.

Baseline evaluation and collection of data:

Patients will be screened for eligibility on the phone, and if eligible and they accept they will be scheduled to a visit at the hospital where the following data will be registered for all participants prior to surgery:

* Age at time of surgery
* Known co-morbidity
* Body Mass Index (BMI)
* Medicine status
* Smoking
* Partner status
* Level of education
* Employment Clinical status
* Clinical stage (cT-staging)
* Gleason score
* Prostate specific antigen (PSA)

Prior to surgery participants will also have answered the questionnaires listed either prior to or during the first visit and have undergone an MRI and the bulbocavernosus-reflex test:

* ICIQ (International Consultation on Incontinence Questionnaire) form about incontinence symptoms
* Danish Prostate Symptom Score (DAN-PSS)
* International Prostate Symptom Score (IPSS)
* International Index of Erectile Function (IIEF) score
* Erection Hardness Scale (EHS) score
* Presence or absence of bulbocavernosus-reflex. The physician test for this by shortly squeezing the penis while observing if the urethra retracts or the anal sphincter contracts. The test is not painful and only takes a few seconds.
* Magnetic Resonance Imaging (MRI) scan with measurements of the urethral length and width, and prostate volume along with other specific anatomical structures in relation to the urethra. Contrast agents will not be applied.

Intraoperative data:

* Contraction of the sphincter musculature during stimulation via the nerve monitoring system before removal of the prostate gland
* Contraction of the sphincter musculature during stimulation via the nerve monitoring system after removal of the prostate gland.
* Blood loss
* Non- or unilateral nerve sparring
* Lymph node dissection
* Total surgical time
* Sphincter lesion
* The surgeon's subjective prediction whether the patient will return to continence postoperatively

During the procedure, through discharge and before follow-up regime begins, the following data points will be collected:

* Time to removal of catheter
* Leakage of the anastomosis
* Stricture.
* Other adverse effects
* Pathologic cancer stage (pT-stage)
* Pathologic Gleason score
* Status of surgical margins

Follow-up evaluation.

Subjects will be evaluated 14 days after catheter removal and at standard clinical controls at 3, 6 and 12 months. The following questionnaires are answered at every visit:

* International consultation on Incontinence Questionnaire (ICIQ) for incontinence,
* Danish Prostate Symptom Score (DAN-PSS)
* International Prostate Symptom Score (IPSS)
* International Index of Erectile Function (IIEF) and Erection Hardness Scale (EHS).

During the last 3 visits subjects also answers a fluid intake/output questionnaire and hand in the results of a 24-hour pad test. In addition to the questionnaires the patients will also undergo an MRI and a bulbocavernosus reflex test 12 months postoperative.

Intraoperative Nerve Monitoring During Robotic-assisted Radical Prostatectomy

Can Intraoperative Nerve Monitoring Predict and Improve Functional Outcomes After Robotic-assisted Radical Prostatectomy

Difference in total International consultation on incontinence questionnaire (ICIQ)-score between the 2 groups after a follow-up of 1 year.

ICIQ is a self-reported survey and screening tool for incontinence. It consists of 3 questions regarding symptoms in the past 4 week, with an overall 0-21 score, where greater values indicate increased severity. Question 1 scores from 0-5, question 2 scores either 0,2,4 or 6 and question 3 scores from 0-10. Only the total score is evaluated. Furthermore there is 1 self-diagnostic question.

Difference in erection rates and sexual activity between the 2 groups after 12 months. Sexual activity defined as yes to the question "Within the last 3 months, have you been sexually active and attempted intercourse?" Erection is defined as a score of at least 17 on the IIEF-5 form and or a score of a least 3 on the EHS form with the use of either no assistance phosphodiesterase 5 inhibitors

Correlation between nerve signal prior to removal of the prostate and preoperative urinary function

Correlation between nerve signal prior to removal of the prostate and preoperative erectile function

Correlation between nerve signal after removal of the prostate and postoperative urinary function

Correlation between nerve signal after removal of the prostate and postoperative erectile function

Difference in Time to continence between the two groups

Herlev and Gentofte Hospital

Central Nervous System Depressants

Pharmaceutical Solutions

Anesthetics

Bupivacaine

Anesthetics, Local

A total of 100 mg bupivacaine (20 mL of 5 mg/mL solution) administered once by subcutaneous injection while patient is under general anesthesia at end of operation.

A total of 20 mL on injectable saline(0.9% NS) administered once by subcutaneous injection while patient is under general anesthesia at end of operation.

Saline

Ketan K. Badani, M.D.

Chris O. Wambi, M.D.

Mitchell C. Benson, M.D.

The indwelling urethral foley is a major source of discomfort following radical prostatectomy. Our hypothesis is that intra-operative dorsal penile nerve block with bupivacaine may decrease immediate post-operative foley discomfort.

Patients undergoing robot-assisted radical prostatectomy (RARP) will be randomized in a double-blind placebo controlled manner to undergo penile ring block injection at the time of skin incision closure. A visual analog scale (VAS) based questionnaire including newly developed foley discomfort scores will be administered at various time points post-operatively.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quality of Life Study for Prostate Cancer Patients	NCT00561444	Prostate Cancer	Questionnaire	18 Years -	M.D. Anderson Cancer Center
Use of Hypothermia During Robotic Prostatectomy	NCT00915031	Prostate Cancer	UroCool	18 Years -	University of California, Irvine
Quality of Life Study for Prostate Cancer Patients	NCT00561444	Prostate Cancer	Questionnaire	18 Years -	M.D. Anderson Cancer Center
Intraoperative Nerve Monitoring During Robotic-assisted Radical Prostatectomy	NCT03721029	Humans Urinary Inconti... Male Urogenital... Prostatectomy Erectile Dysfun...	Intraoperative ... standard of car...	-	Herlev and Gentofte Hospital
Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort	NCT01565512	Prostate Cancer Robotic Prostat... Foley Catheter ...	Bupivacaine Saline	40 Years - 80 Years	Columbia University
Intraoperative Nerve Monitoring During Robotic-assisted Radical Prostatectomy	NCT03721029	Humans Urinary Inconti... Male Urogenital... Prostatectomy Erectile Dysfun...	Intraoperative ... standard of car...	-	Herlev and Gentofte Hospital

Spots Global Cancer Trial Database for robotic prostatectomy