Behaviors and Mental Disorders

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Anxiety Disorders

Prostatic Neoplasms

Adenocarcinoma

Pain

Prostatic Hyperplasia

Hyperplasia

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Mental Disorders

Psychotic Disorders

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Bupivacaine

Nitrous Oxide

Anesthetics

Anesthetics, Inhalation

Anesthetics, General

Analgesics, Non-Narcotic

Patients will receive SANO in addition to periprostatic bupivacaine nerve block for the duration of prostate biopsy.

After the Urologist describes the procedure, the SANO group will have nitrous oxide turned on to 30%, ensuring that the patient is relaxed but still conversant through the procedure. The nitrous will be adjust up or down based on the patient's response to the question "are you feeling the nitrous" and "are you happy at this level". The range will be between 25 - 45%. At the end of the procedure, the SANO group will be turned down to 0% nitrous oxide, and 100% oxygen will be administered through the mask for an additional 2-3 minutes as the patient is cleaned up and repositioned to the supine position.

Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy.

Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.

Self-Administered Nitrous Oxide

Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.

Oxygen

Heidi Rayala, MD, PhD

Transrectal prostate biopsy is a commonly performed ambulatory procedure for diagnosing prostate cancer. Prostate biopsy are associated with pain or anxiety. Nitrous oxide (or laughing gas) is a well-known inhaled anesthetic which is frequently used in dental offices and for pediatric procedures to alleviate a patient's anxiety and pain. This study seeks to determine whether administration of nitrous oxide at the time of prostate biopsy will improve a patient's experience of care.

Nitrous oxide is a well-tolerated inhaled anesthetic that has been used for decades in pediatric and adult populations and is largely viewed as effective and safe. In addition to analgesic effect, nitrous oxide also produces a dissociative euphoria and amnesia that could potentially improve patients' anxiety and experience of cancer care. When used as a single agent at concentrations ≤50%, the American Society of Anesthesiologists (ASA) classifies nitrous oxide as Minimal Sedation, producing a state in which a patient responds normally to verbal commands, maintains airway reflexes, and spontaneous ventilation. Over the past several decades nitrous oxide has become less common due to concerns of nitrous oxide environmental exposure to the care team. There are now Federal Drug Administration (FDA)-approved systems that allow patient self-administered nitrous oxide (SANO), and importantly, include a scavenger system to eliminate exhaled environmental nitrous oxide. These systems are rapidly being adopted throughout the United States in Urology practices, but to date, there have been no studies evaluating patient outcomes and possible risks with the adjunct use of SANO. This study is a prospective, randomized, controlled trial to assess patient perceived pain and anxiety related to prostate needle biopsy with or without SANO, and the frequency of complications associated with SANO. A secondary aim will be to demonstrate that the SANO at the time of prostate biopsy does not significantly increase burden on Urologist productivity, nor increase the difficulty of operator ease in performing the prostate needle biopsy.

Subjects will be randomized 1:1 to either SANO (treatment) or oxygen (placebo control) after completion of baseline assessment. The results of the randomization will not be disclosed to patients as part of the study (patient-blinded).

The operating urologist and study participant will be blinded to group assignment for the duration of the study.

Participants with a prostate may be eligible for the study.

Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain

IPD is not intended to be shared to personnel outside of pre-defined research staff.

Pain experienced immediately following prostate biopsy as measured by a Visual Analog Scale for Pain (VAS-P) (range: 0 \[no pain\] - 10 \[worst pain\])

Anxiety experienced immediately following prostate biopsy as measured by a Visual Analog Scale for Anxiety (VAS-A) (range: 0 \[no anxiety\] - 10 \[worst anxiety\])

Anxious traits exhibited after prostate biopsy as measured by the State Trait Anxiety Inventory (STAI) (range: 6-36; 36 being 'worst' anxiety).

Length of procedure will be compared between arms to assess whether SANO significantly lengthens prostate biopsy

Operating urologist filled out a survey to assess their perception of patient: Tolerating Insertion of rectal probe. Responses were scored on a 3-point Likert scale as 1 (worse than expected), 2 (as expected), or 3 (better than expected).

Operating urologist filled out a survey to assess their perception of patient: Patient maintenance of positioning. Responses were scored on a 3-point Likert scale as 1 (worse than expected), 2 (as expected), or 3 (better than expected).

Operating urologist filled out a survey to assess their perception of patient: Patient Tolerance of Procedure. Responses were scored on a 3-point Likert scale as 1 (worse than expected), 2 (as expected), or 3 (better than expected).

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Principal Investigator

Patients will receive SANO in addition to periprostatic bupivacaine nerve block for the duration of prostate biopsy.

After the Urologist describes the procedure, the SANO group will have nitrous oxide turned on to 30%, ensuring that the patient is relaxed but still conversant through the procedure. The nitrous will be adjust up or down based on the patient's response to the question "are you feeling the nitrous" and "are you happy at this level". The range will be between 25 - 45%. At the end of the procedure, the SANO group will be turned down to 0% nitrous oxide, and 100% oxygen will be administered through the mask for an additional 2-3 minutes as the patient is cleaned up and repositioned to the supine position.

Self-Administered Nitrous Oxide: Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.

Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy.

Oxygen: Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.

Total

Age, Continuous

Sex: Female, Male

White

Black/African American

Other

Race/Ethnicity, Customized

United States

Region of Enrollment

History of Prostate Cancer Prior to Enrollment

Past Medical History of Depression

Past Medical History of Anxiety

Pre-procedural anxiety was assessed using the Visual Analog Scale for Anxiety (VAS-A, range:0-10, higher scores indicating worse anxiety).

Pre-Biopsy VAS-Anxiety

Pre-procedural pain was measured by the Visual Analog Scale for Pain (VAS-P, range:0-10, with greater scores indicating worse pain).

Pre-Biopsy VAS-Pain

Pre-procedural anxiety was assessed using the State Trait Anxiety Inventory (STAI, range:6-24, higher scores indicate worse anxiety)

Pre-Biopsy STAI

Dr. Heidi Rayala

Post-biopsy Pain (VAS-P)

Post-biopsy Anxiety (VAS-A)

Post-biopsy Anxiety Traits (STAI)

Time of Prostate Biopsy

Operator Assessment of "Tolerating Insertion of Rectal Probe"

Operator Assessment of "Patient Maintenance of Positioning"

Operator Assessment of "Patient Tolerance of Procedure"

Overall Study

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Quality of Life

Neuroendocrine Tumor

Neuroepithelioma

Clinical surveillance standard of care with addition of 2D or 3D Melanoma Surveillance Photography and digital dermoscopy.

Clinical surveillance standard of care without Melanoma Surveillance Photography.

Total body imaging using 2D or 3D Melanoma Surveillance Photography plus digital dermoscopy.

2D or 3D Melanoma Surveillance Photography

Victoria Mar

This randomised controlled trial will investigate the role of melanoma surveillance photography (MSP) in the surveillance of patients at high or ultra-high risk of melanoma. MSP is a comprehensive method of melanoma monitoring which includes total body photography and digital dermoscopy which is performed at prescribed intervals. The study will test whether participants under surveillance with MSP have less unnecessary biopsies (false positives) compared to those without MSP. Participants will be Australian residents with a new diagnosis of primary melanoma, who have multiple naevi and are at high or ultra-high risk of developing melanoma. Participants will be randomised 1:1 to either groups.

It is hypothesised that those randomised to surveillance with MSP will have better patient outcomes. Improved diagnostic performance as measured by the number of unnecessary biopsies will be the primary outcome measure.

The primary aim is to test whether melanoma surveillance with MSP, comprising either 2D or 3D TBP tagged with digital dermoscopy, compared to clinical surveillance without MSP, results in improved diagnostic performance, specifically reduced number of unnecessary biopsies (i.e. false positives due to an excision or biopsy of a lesion being performed to diagnose melanoma and that lesion being identified on pathology as benign), in high (and very high) risk individuals whose risk is contributed to by high naevus counts.

The secondary aims are to:

1. Evaluate whether MSP:

   1. Results in improved sensitivity of doctors' diagnosis of melanoma (i.e. reduction in false negatives)
   2. Improves health-related quality of life, patient satisfaction, and reduces patient anxiety
   3. Reduces costs to patients and health care system
2. Evaluate the safety and acceptability of MSP
3. Evaluate benefit of MSP in high risk patients prior to a primary melanoma diagnosis (Sub-study 1)
4. Evaluate diagnostic performance of tele-dermatology compared to en-face clinical visits (Sub-study 2).

Investigators hypothesise that for ultra-high and high risk patients with multiple naevi, clinical surveillance with melanoma surveillance photography (compared to without MSP) will lead to better patient outcomes, in particular a reduction in the number of unnecessary biopsies (i.e. false positives) as a measure of diagnostic performance. Secondary hypotheses include that for ultra-high, and high risk patients with multiple naevi, clinical surveillance with MSP (compared to without MSP) will lead to:

1. Reduction in the number of misclassified melanoma malignancies (i.e. false negatives);
2. Reduction in the number of misclassified melanocytic and keratinocyte lesions combined;
3. Improved quality of life; and
4. Favourable health economic outcomes.

The trial is an open-label, multi-site, parallel-arm randomised controlled trial. Participants meeting the eligibility criteria will be randomised 1:1 to either standard care or the intervention arm. Randomisation will be 1:1 to either Intervention or Control group stratified by high/ultra-high risk of 2nd primary melanoma, sex, 2D/3D imaging, GP/Dermatologist.

Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients

To estimate the benefit of MSP in high risk patients prior to a melanoma diagnosis, amongst participants who would have been classified as 'high risk' at the time of their primary melanoma, this sub-study will compare:

i) Breslow thickness of the primary melanoma at entry into this trial, and ii) Biopsy rates prior to diagnosis

Approximately 100 paired sets of 3D surveillance and digital dermoscopy images (baseline and follow-up) taken from patients in the intervention arm, will be sent to 10 participating study doctors (both GPs and dermatologists; all 100 pairs sent to all 10 doctors) for teledermatology assessment. The study doctors will assess the images with respect to whether they have a melonama present or not. Images will be selected randomly from amongst patients accrued to the main study for this telediagnosis validation study. Approximately 30% of these will include an image of a melanoma confirmed by histopathology (gold standard) during the trial. This substudy will not affect patient care but will assess diagnostic performance (sensitivity and specificity) in the teledermatology setting compared to the en-face clinical setting in order to validate the use of telediagnosis in routine care.

The primary outcome is the diagnostic performance of surveillance for melanoma, expressed as the number of false positive biopsies per patient over a 24-month period.

Standard health economic cost-effectiveness measures.

Assessment of Quality of Life (AQOL-8D) questionnaire for calculation of quality-adjusted life years (QALYs). Minimum score per each of 8 questions is 1; maximum score is 5, where higher score represents worse outcomes. Scores may be aggregated to provide an overall index of the health state utility per participant, where higher scores indicate worse quality of life outcomes.

European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), Fear of Cancer Recurrence - short form (FCR4) and a purpose-designed patient acceptability scale will be utilised to synthesise a single endpoint measure for patient anxiety. Value range is 0 to 100, where higher values represent greater anxiety (worse outcomes).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain	NCT05803096	Prostate Diseas... Malignancy Benign Prostati... Prostate Cancer Prostate Adenoc... Anxiety and Fea... Pain	Self-Administer... Oxygen	18 Years - 85 Years	Beth Israel Deaconess Medical Center
Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain	NCT05803096	Prostate Diseas... Malignancy Benign Prostati... Prostate Cancer Prostate Adenoc... Anxiety and Fea... Pain	Self-Administer... Oxygen	18 Years - 85 Years	Beth Israel Deaconess Medical Center
Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients	NCT04385732	Melanoma Skin Cancer Anxiety and Fea...	2D or 3D Melano...	18 Years -	Melanoma and Skin Cancer Trials Limited

Spots Global Cancer Trial Database for anxiety and fear