Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Patients will be preverved the neurovascular bundles during the resection of bladder and prostate of the operation.

Patients will receive standard radical cystectomy (not preserve the neurovascular bundles) during the operation.

When resect the bladder and prostate, the neurovascular bundles around the prostate will be preserved.

nerve sparing

Kaiwen Li, MD

Jian Huang, MD

To compare the perioperative, functional, and oncologic outcomes between non nerve sparing and nerve sparing robot-assisted radical cystectomy with orthotopic ileal neobladder in male patients with bladder cancer.

This study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy with orthotopic ileal neobladder. The patients will be distributed into two comparable groups according to surgical procedures: non nerve sparing group and nerve sparing group. Patient demographic and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.

Nerve Sparing Versus Non Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male

Patients were considered continent when they required 0 or 1 safety pad during the day-time.

Patients were considered continent when they required 0 or 1 safety pad during the night.

The sexual function are evaluated by the International Index of Erectile Function-5 (IIEF-5).

First Affiliated Hospital, Sun Yat-Sen University

Third Affiliated Hospital, Sun Yat-Sen University

Shantou Central Hospital

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Symptoms and General Pathology

Prostatic Neoplasms

Facies

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

The patients will undergo radical prostatectomy with nerve sparing decisions based on the results of the NeuroSAFE technique

Frozen section analysis of the posterolateral surface of the prostate to guide nerve sparing decisions.

NeuroSAFE procedure

The LaserSAFE procedure is performed using an FCM called the Histolog® scanner developed by Samantree® which can be placed within the operating room. The Histolog® scanner produces digital images with high, micrometre-range resolution and enables the visualization of tissue microstructures down to the cellular level.

LaserSAFE procedure

Greg Shaw

Ricardo Almeida Magana

Prostate cancer is the most common solid cancer affecting male patients worldwide. When diagnosed early, it can usually be cured with surgery (radical prostatectomy), but this procedure is associated with side effects such as urinary incontinence and erectile dysfunction. If the nerves that surround the prostate are left intact (nerve-sparing), the risk of developing these side effects decreases. However, since these nerves are in intimate contact with the prostate there is a chance of leaving cancer cells behind, with the subsequent need for additional treatments. Sadly, the current methods surgeons use to select patients who can safely be offered nerve-sparing are not very accurate in predicting where the tumour is extending outside the prostate.

NeuroSAFE is a technique that can inform the surgeon if there are tumour cells on the surface of the prostate and indicate the need for removing more tissue during the same operation. However, it requires a specialised team to process the sample in a reasonable amount of time that does not excessively prolong the surgery. Therefore, many centres are not able to perform it.

A new technology called fluorescence confocal microscopy (LaserSAFE) can be used to examine the surface of the prostate and can identify when cancer is present. Critically, it requires minimal training and resources to produce results in a few minutes and the microscope can be placed in the operating room.

The investigators aim to recruit a group of 20 patients who will undergo radical prostatectomy as a treatment for prostate cancer. The prostate specimen will be analysed using both techniques, but decisions on how much tissue to resect during surgery will depend on the results of NeuroSAFE. This feasibility study will allow us to understand the challenges associated with performing both techniques. This will allow us to plan a larger study to evaluate the accuracy of LaserSAFE.

This trial will be a multi-site, single-blinded, prospective, feasibility study. 20 participants will be recruited from 2 centres that have experience performing the NeuroSAFE technique. Participants will undergo a robotic-assisted radical prostatectomy with nerve-sparing guided by the NeuroSAFE technique. Before the prostate is sent for evaluation the LaserSAFE technique will be used to analyse the corresponding posterolateral surfaces of the prostate. Participating pathologists involved in interpreting the results of NeuroSAFE will be blinded to the LaserSAFE results, to avoid influencing standard patient treatment, management, and progression outcomes after radical prostatectomy.

The investigators aim to recruit a group of 20 patients who will undergo radical prostatectomy as a treatment for prostate cancer. The prostate specimen will be analysed using both techniques, but decisions on how much tissue to resect during surgery will depend on the results of NeuroSAFE.

After LaserSAFE, images are acquired, they will be annotated with the study identifier only. Images will be stored and kept until the end of recruitment. Once all specimens have been evaluated using paraffin analysis, a dedicated meeting with the evaluating pathologist will be carried out. A set of images without any patient identifier will be shown in random order. A purposely built document will allow the pathologist to report the images. This meeting will be repeated with every evaluating pathologist until all images have been analysed.

Study to Evaluate a New Method to Detect Residual Tumours During Surgery for Prostate Cancer Using Confocal Microscopy

A Feasibility Trial to Evaluate Margin Status During Radical Prostatectomy With En-face Fluorescence Confocal Microscopy (LaserSAFE) Compared to NeuroSAFE

There are currently no plans to share individual participant data as this is a feasibility study with low number of participants

Evaluate the feasibility of using the LaserSAFE technique to evaluate margin status during radical prostatectomy compared to the NeuroSAFE technique

Concordance between LaserSAFE and NeuroSAFE recommendation on secondary resection during radical prostatectomy

University College London Hospitals

University College, London

The conventional robotic-assisted radical prostatectomy is the gold standard approach to prostate cancer surgery.

A novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate. These structures are disrupted and removed during conventional radical prostatectomy.

The conventional approach to prostate cancer surgery

Robot-assisted radical prostatectomy (RP)

A novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate.

Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)

Jim C Hu, MD MPH

Bouchra S Benghomari, BS

Keith Kowalczyk, MD

Mary Kate Keeter, MPH

Edward M Schaeffer, MD PhD

Rana Harb, MS

Mohamad E Allaf, MD

This is a prospective, randomized controlled trial to compare cancer control and health-related quality of life following pelvic fascia-sparing radical prostatectomy versus standard radical prostatectomy.

The investigators hypothesize that pelvic fascia-sparing radical prostatectomy will have similar cancer control (primary outcome) and sexual function outcomes; and significantly better urinary function, penile shortening/deformity and inguinal hernia risks as compared to radical prostatectomy.

Traditional radical prostatectomy is the most popular treatment for clinically significant prostate cancer, however significant risks including urinary incontinence, erectile dysfunction, penile shortening, penile curvature/ deformation (Peyronie's disease), and inguinal hernia, are common. Pelvic fascia-sparing radical prostatectomy is a new surgical technique that may preserve fascial support structures, arterial supply to the penis, and nerves that are severed and resected during conventional radical prostatectomy.

This study will enroll adult men undergoing radical prostatectomy for clinically localized prostate cancer. Subjects will be randomized to receive either radical prostatectomy or pelvic fascia-sparing radical prostatectomy. Investigators will compare cancer control and health-related quality of life outcomes through patient questionnaires and medical record review.

Outcomes assessors (i.e., pathologists) will be blinded to randomization.

Clinical Trial of Approaches to Prostate Cancer Surgery

Clinical TrIAL of Approaches to Prostate cAncer suRgery

Presence of cancer cells at the prostate margin is standardized as a positive surgical margin through professional guideline consensus.

Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.

In accordance with National Comprehensive Cancer Network (NCCN) guidelines, investigators will capture PSA persistence as failure of PSA to fall to undetectable levels, and PSA recurrence as an undetectable PSA after surgery with a subsequent detectable PSA that increases on 2 or more determinations.

Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.

The questionnaire will include 20 items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), survey items pertinent to short-stay cancer surgery.

The questionnaire will assess patient-reported complications and adverse events, such as constipation, nausea and vomiting, fever, chills, fatigue, pain, shortness of breath, swelling and bruising, redness and discharge at the surgical incision site, anxiety, and flatulence (ileus). It will also assess patient contacts with physicians and admittance to urgent care or the emergency room.

The Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) is a 7-item questionnaire assessing two health-related quality of life domains: urinary and sexual function. All questions refer to patients' health and symptoms in the last four weeks.

Each domain is scored out of 12 points, with higher scores indicating more complications.

In total, the EPIC-CP score is the final sum of the two domains, with higher scores indicating more issues related to overall prostate cancer quality of life.

This is a 5-item questionnaire, published in the New England Journal of Medicine (NEJM), that has face validity for assessing penile shortening, self-esteem, and erectile function after radical prostatectomy.

Question 1 assesses patients' perceived penile length post-surgery, compared to penile length at 30 years of age. It consists of two possible responses: Yes or No.

Questions 2 and 3 assesses patients' ability to obtain and quality of spontaneous morning erections and sexual activity-related erections. It consists of five possible responses: ranging from "No erections" to "Erections always sufficient".

Question 4 is a visual digital scale assessing patients' present quality of life. It is scored on a scale of 1-7, with higher scores indicating high quality of life.

Question 5 is a visual digital scale assessing patients' present self-esteem. It is scored on a scale of 1-7, with higher scores indicating high self-esteem.

This is a validated, 3-item questionnaire assessing presence of Peyronie's disease. The penile deformity items were validated by blinded clinical examination with 100% sensitivity and 99.4% specificity.

Question 1 assesses penile hardening/plaques in the flaccid state. Question 2 assesses penile curvature in the erect state. Question 3 assesses pain associated with erection. Each question consists of two possible responses: Yes or No.

This is a 5-item questionnaire assessing treatment regret that was developed and validated in men with prostate cancer.

Each item is scored on a 5 point scale ranging from "Strongly Agree" to "Strongly Disagree". Responses are converted to a score ranging from 0-100, with higher scores indicating more regret.

This is a 5-item questionnaire assessing treatment regret that was developed and validated in men with prostate cancer.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Weill Medical College of Cornell University

Behaviors and Mental Disorders

Urinary Incontinence

Enuresis

Quality of Life

Using the Retzius technique, the surgeon will remove the prostate in a way that preserves a portion of the nerves and tissue structures that are typically removed during the conventional technique.

A non-Retzius nerve sparing technique will be performed, according to surgeon's preference--nerve sparing during radical prostatectomy is performed with significant variation and there is an absence of universally agreed upon steps or techniques.

Retzius nerve sparing is a specific approach that avoids disrupting the structures involved in urinary and sexual function.

Retzius sparing

The investigators propose a prospective study to assess recovery of urinary and sexual function by nerve sparing techniques after radical prostatectomy.

Subjects will be randomized in a 1:1 ratio to Retzius nerve sparing versus non-Retzius nerve sparing to compare cancer outcomes and urinary/sexual outcomes following radical prostatectomy. Using the Retzius technique, the surgeon will remove the prostate in a way that preserves a portion of the nerves and tissue structures that are typically removed during the conventional technique.

The investigators will assess recovery of urinary and sexual function of patients through questionnaires at 1 week, 1 month, 6 months, 12 months, and 24 months after surgery.

Randomized controlled trial comparing Retzius sparing robot-assisted radical prostatectomy versus conventional robot-assisted radical prostatectomy

A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy

Individual participant data (IPD) will not be shared with other researchers.

The investigators will obtain patient-reported complications and adverse events captured from patient's medical record.

Patients will fill out the EPIC-CP questionnaire. The EPIC-CP is a 10-item questionnaire assessing five health-related quality of life domains: urinary function, urinary irritation, bowel function, sexual function, and hormonal issues. All questions are about patients' health and symptoms in the last four weeks.

Each domain is scored out of 12 points, with higher scores indicating more complications.

In total, the EPIC-CP score is the final sum of the 5 domains. The EPIC-CP is scored out of 60 points, with higher scores indicating more issues related to overall prostate cancer quality of life.

The investigators will obtain patient's PSA values from their medical record, at baseline and up to 24 months post-surgery. Patient PSA levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.

Patients will fill out a validated, 5-item questionnaire assessing penile shortening, self-esteem, and presence of erections.

Question 1 assesses patients' perceived penile length post-surgery, compared to penile length at 30 years of age. It consists of two possible responses: Yes or No.

Questions 2 and 3 assesses patients' ability to obtain and quality of spontaneous morning erections and sexual activity-related erections. It consists of five possible responses: ranging from "No erections" to "Erections always sufficient".

Question 4 is a visual digital scale assessing patients' present quality of life. It is scored on a scale of 1-7, with higher scores indicating high quality of life.

Question 5 is a visual digital scale assessing patients' present self-esteem. It is scored on a scale of 1-7, with higher scores indicating high self-esteem.

Patients will fill out a validated, 3-item questionnaire assessing presence of Peyronie's disease.

Question 1 assesses penile hardening in the flaccid state. Question 2 assesses penile curvature in the erect state. Question 3 assesses pain associated with erection. Each question consists of two possible responses: Yes or No.

Patients will fill out a validated, 5-item questionnaire assessing feelings toward treatment regret.

Each item is scored on a 5 point scale ranging from "Strongly Agree" to "Strongly Disagree". Responses are converted to a score ranging from 0-100, with higher scores indicating more regret.

A prostate model was 3D printed from preoperative pelvic MRI data and used during surgery to mark a positive surgical margin and guide secondary resection.

A prostate model was 3D printed from preoperative pelvic MRI data and used during robot-assisted radical prostatectomy to mark a positive surgical margin and guide secondary resection.

3D model guided secondary resection

Christian CE Engesser, Dr.

Jan JE Ebbing, PD Dr. med

To optimize precision for secondary resection (SR) in frozen section (FS) controlled nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized 3D-printed prostate model.

Background:

Nerve-sparing (NS) robot-assisted radical prostatectomy (RARP) offers optimized oncological and functional outcomes and has become the preferred minimally-invasive approach when available. To maximize oncologic safety in NS-RARP, a frozen section (FS) can be used but does not provide a visual impression of the positive surgical margin (PSM) to guide secondary resection (SR).

Objective:

To optimize precision for secondary resection (SR) in frozen section (FS) controlled nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized 3D-printed prostate model.

Design, setting and participants:

100 patients with NS-RARP performed between September 2018 and August 2021 were included in this prospective multicenter cohort study.

Interventions:

A prostate model was 3D printed from preoperative pelvic MRI data and used during surgery to mark a PSM and guide SR.

Outcome Measurements and statistical analysis Endpoints were comparison of the primary surgical margin status in the FS with the tissue of the resulting SR and with the final surgical margin status. Secondary parameters for oncological and erectile outcomes were assessed before and one year after surgery.

Nerve-sparing, Robot-assisted Radical Prostatectomy Using a Personalized, 3D-printed Prostate Model for Selective Resection of Positive Surgical Margins

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nerve Sparing Versus Non Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male	NCT05018429	Bladder Cancer	nerve sparing	18 Years -	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study to Evaluate a New Method to Detect Residual Tumours During Surgery for Prostate Cancer Using Confocal Microscopy	NCT06398470	Prostate Cancer	NeuroSAFE proce... LaserSAFE proce...	18 Years -	University College, London
Nerve Sparing Versus Non Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male	NCT05018429	Bladder Cancer	nerve sparing	18 Years -	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Clinical Trial of Approaches to Prostate Cancer Surgery	NCT05155501	Prostate Cancer	Robot-assisted ... Pelvic fascia-s...	40 Years - 80 Years	Weill Medical College of Cornell University
Clinical Trial of Approaches to Prostate Cancer Surgery	NCT05155501	Prostate Cancer	Robot-assisted ... Pelvic fascia-s...	40 Years - 80 Years	Weill Medical College of Cornell University
Clinical Trial of Approaches to Prostate Cancer Surgery	NCT05155501	Prostate Cancer	Robot-assisted ... Pelvic fascia-s...	40 Years - 80 Years	Weill Medical College of Cornell University
Study to Evaluate a New Method to Detect Residual Tumours During Surgery for Prostate Cancer Using Confocal Microscopy	NCT06398470	Prostate Cancer	NeuroSAFE proce... LaserSAFE proce...	18 Years -	University College, London
A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy	NCT04393831	Prostate Cancer Quality of Life	Retzius sparing	40 Years - 80 Years	Weill Medical College of Cornell University
Clinical Trial of Approaches to Prostate Cancer Surgery	NCT05155501	Prostate Cancer	Robot-assisted ... Pelvic fascia-s...	40 Years - 80 Years	Weill Medical College of Cornell University
Nerve-sparing, Robot-assisted Radical Prostatectomy Using a Personalized, 3D-printed Prostate Model for Selective Resection of Positive Surgical Margins	NCT05960669	Prostate Cancer	3D model guided...	18 Years - 80 Years	University Hospital, Basel, Switzerland
Nerve Sparing Versus Non Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male	NCT05018429	Bladder Cancer	nerve sparing	18 Years -	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Spots Global Cancer Trial Database for nerve sparing