Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Using focal therapy(high-frequency Irreversible electroporation) to treat patients with localized Prostate cancer

Using laparoscopic radical prostatectomy to treat patients with localized Prostate cancer

High-frequency irreversible electroporation will be performed via the perineum with the guidance of ultrasound under general anaesthesia to the patient with localized prostate cancer

Focal therapy(high-frequency irreversible electroporation)

laparoscopic radical prostatectomy

Biming He, MD

Haifeng Wang, MD

This trial is comparing the functional and oncological outcomes in treating men with prostate cancer between high-frequency irreversible electroporation and laparoscopic radical prostatectomy.

Two hundred and sixteen patients with localized prostate cancer will include in this study. The clinical trial validation process will be as follows: (1) all patients are randomly divided into two arms: arm 1, high-frequency irreversible electroporation; group 2, laparoscopic radical prostatectomy. The primary outcome is the urinary function and sexual function.

Comparison H-FIRE and Laparoscopic RP in Treating Men With Localized Prostate Cancer

A Prospective, Single-center, Randomized Controlled Trial Comparing the Functional and Oncological Outcomes of High-frequency Irreversible Electroporation and Laparoscopic Radical Prostatectomy in Men With Localized Prostate Cancer

The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score

The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score

The urinary function will be measured by a separate EPIC pad-use item

The urinary function will be measured by IPSS (International Prostate Symptom Score)

The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score

The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)

is defined either of the following items: (1) clinical evidence of progression (any of the positive results from the bone scan, pelvic MRI/CT, PSMA-PET MR/CT); (2) a positive biopsy (for the H-FIRE arm only); (3) biochemical failure (BCR, for the RP arm only, defined as a serum PSA level higher than 0.4 ng/ml after surgery)

measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score

measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)

measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score

measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score

measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score

measured by Hospital Anxiety and Depression Scale (HADS)

defined as biopsy show cancer remain at 6 months after H-FIRE procedure, or a PSA level 0.4ng/ml or higher at 3 months after RP procedure

defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery

the number of patients need blood transfusion

measured by a surgical pain scale range from 0 to 10

identified by the Common Terminology Criteria for Adverse Events (CTCAE)

Shanghai East Hospital

The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.

Radical prostatectomy

Hoang PC Nguyen, Associate Professor, MD, PhD

Linh NK Tran, MD, PhD

Hung V Tran, MD, PhD

This study is to compare the outcomes of robotic-assisted laparoscopic radical prostatectomy (RARP) and laparoscopic radical prostatectomy (LRP) for prostate cancer treatment in terms of perioperative surgical, functional and oncological outcomes.

Participants will either have robotic-assisted laparoscopic radical prostatectomy (RARP) or laparoscopic radical prostatectomy (LRP) as determined by the treating surgeon. All participants will undergo tests and questionnaires to determine urinary and erectile function, biopsies to determine perioperative surgical, functional and oncological outcomes. These assessments will be conducted pre-operatively, post-operatively and at certain follow-up time points up to 12 months.

Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment

The time which surgeon spends on the robot console by minuite

The number of cases which will be transfused.

Number of cases, based on the result of pathology.

The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain, in a total of 10 points, higher score means worse, with 0 means no pain and 10 is the worst pain. The mean score will be calculated to reflect the post-operative pain.

including ultrasound when PSA rising or any indication of recurrent

including MRI when PSA rising or any indication of recurrent

including PET Scan, when PSA rising or any indication of recurrent

It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life. The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points. The sum score will be calculated and the mean score will be evaluated.

The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity). The mean score will be calculated.

The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The mean score will be calculated.

Binh Dan Hospital

Adenocarcinoma

Antineoplastic Agents

Docetaxel

Tubulin Modulators

Antimitotic Agents

docetaxel

Karim Fizazi, Dr

This is a prospective phase II study of peri-operative docetaxel plus laparoscopic radical prostatectomy in patients with localized Gleason 7 pT2a-pT2b adenocarcinoma of the prostate and a risk of relapse after radical prostatectomy.

Study of Peri-Operative Docetaxel Plus Laparoscopic Radical Prostatectomy in Prostate Cancer Patients

A Prospective Phase II of Peri-Operative Docetaxel + Laparoscopic Radical Prostatectomy in Patients With Localized Gleason 7 pT2a-pT2b Adenocarcinoma and a Risk of Relapse After Radical Prostatectomy

Gustave Roussy, Cancer Campus, Grand Paris

Vasodilator Agents

Urological Agents

Anticoagulants

Other Dietary Supplements

Sildenafil Citrate

Citric Acid

Sodium Citrate

Phosphodiesterase 5 Inhibitors

Phosphodiesterase Inhibitors

Enzyme Inhibitors

Citrate

Sildenafil

Christian P Pavlovich, MD

The ability of sildenafil to aid in the return of erections after nerve-sparing radical prostatectomy has been established. Patients who had either one or both neurovascular bundles spared demonstrated dramatically better responses to "as needed" sildenafil than those that did not, and a positive erectile response to sildenafil was only seen in patients in whom at least one NVB was spared. This study has been designed to determine if sildenafil taken nightly works better than sildenafil on as "as needed" basis for the return of erectile function. The investigators hypothesis is that sildenafil taken nightly promotes a more rapid return of erectile function after nerve-sparing laparoscopic radical prostatectomy.

Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Laparoscopic Radical Prostatectomy

Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Nerve-Sparing Laparoscopic Radical Prostatectomy

Johns Hopkins University

Christian Pavlovich, M.D.

Symptoms and General Pathology

Postoperative Complications

Anesthetics, General

Patients with prostate cancer for whom an ambulatory laparoscopic radical prostatectomy has been validated at a multidisciplinary consultation meeting.

Prostate cancer may require laparoscopic radical prostatectomy, a surgical procedure performed under general anaesthetic.

Laparoscopic radical prostatectomy

Arnaud BALDINI, MD

The purpose of the study is to evaluate the incidence of surgery-related complications between Day 0 and Day 30.

This is an observational, prospective, open, non-comparative (single arm), bicentric study.

This study is aimed at patients with prostate cancer for whom an ambulatory laparoscopic radical prostatectomy has been validated at a multidisciplinary consultation meeting. The possibility of performing this procedure on an outpatient basis is left to the surgeon's discretion, according to well-defined medical procedure criteria.

This cohort is part of the usual care. The study will observe the incidence and describe the type, number, severity, duration and frequency of procedure-related complications that may arise in the first month post-op of ambulatory Laparoscopic Radical Prostatectomy. For this reason, patient follow-up will stop at 1 month after surgery, during a routine follow-up visit.

Outpatient Laparoscopic Radical Prostatectomy

Study of Postoperative Complications After Laparoscopic Outpatient Radical Prostatectomy in Patients With Localized Prostate Cancer

The primary endpoint was the incidence of procedural complications between Day 0 and Day 30.

GCS Ramsay Santé pour l'Enseignement et la Recherche

in Group 3D, an intrafascial nerve-sparing (NS) technique will be performed on the side of the lesion; contralaterally an intra-, inter- or extra-fascial NS technique will be performed. After removal of the prostate, virtual images of the prostate will be projected into the lodge using AI software and will be displayed thanks to the Tile-Pro. The virtual 3D model will allow identifying the extracapsular extension of the tumor lesion, projected at the level of the preserved neurovascular bundle.

A first selective excisional biopsy at the level of the suspected ECE on the NVB will be sent for extemporaneous histological examination. Under 3D AR guidance, a second selective biopsy will then be performed on the NVB at the same level as the first, however involving a larger and thicker layer of tissue. the biopsies will be sent for extemporaneous histological examination. In case of positivity, the entire NVB will be removed

For the no-3D group, the intra-, inter- or extra-fascial NS technique during robotic prostatectomy will be performed according to the clinical indication.

At the end of the demolitive phase a selective biopsu was performed in a cognitive fashion accordin with the information provided by MRI images.

Reconstructive phase was performed according to our previously described total anatomical reconstruction (TAR) technique for both arms.

The operation is performed using the "Da Vinci HD" robotic system which allows the use of laparoscopic instruments, with greater mobility and the possibility of easier and more precise control of movements in three dimensions. Furthermore, the system allows the surgeon a three-dimensional view of the operating field. The surgery is performed under general anesthesia. Six or more trocars are positioned, into which the instruments operated by the robot or directly by the surgical assistants are inserted.

Then a radical prostatectomy is performed.

3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy

Enrico Checcucci, MD

Marco Asioli

Francesco Porpiglia, MD

This is a prospective randomized multicenter study aimed at comparing 3D AI-AR-RARP vs. no 3D, verifying the impact of this new technology on oncological and functional outcomes after the procedure.

Considering that prostate cancer lesions are not identifiable during surgery, except in the case of extensive and advanced tumors, the surgeon does not have a real-time perception of the location of the tumor. The absence of clear spatial visualization can therefore lead to a positive surgical margin, particularly in tumors in the T3 stage (invasion of the prostatic capsule or seminal vesicles).

Our hypothesis is that with the help of AI 3D AR during surgery, positive surgical margins can be avoided, or at least reduced, while preserving the neurovascular bundles, with a consequent improvement not only in postoperative functional outcomes (continence and potency), but also oncological ones (less biochemical disease recovery (BCR), less need for salvage radiotherapy, lower risk of metastasis).

Patients will be randomized using an Excel® macro in 2 group: 3D and no3D, stratifying them by age, PSA, cT, PSA density, prostate volume, lesion volume, extracapsular extension (ECE), seminal vesicle invasion (SVI), biopsy ISUP.

Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention

RIDERS: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention: a Prospective Multicenter Randomized Controlled Trial

Verify the potential application of AI as an alert system during surgery in order to reduce the rate of possible intraoperative complications

Verify oncological outcomes in prostate cancer patients with evidence of bulging or extracapsular disease (ECE or rT3) on preoperative MRI, in terms of positive margin rate (PSM) following surgery

Evaluation of continence recovery rate. Continence was defined as use of 0-1 pads/die. Furthermore 24/h pad test was performed in case of persistence of incontinence to evaluate the different degree of urine losses, and was classified according to ICS definitions.

Evaluation of erection recovery in terms of IIEF-5 (International Index of Erectile Function Questionnaire).

Evaluation of patients' oncological outcomes during the follow up in terms of biochemical recurrence (BCR) and occurrence of local/distant recurrence detected with different imaging techniques during the FU according to clinical indication

San Luigi Gonzaga Hospital

Fondazione del Piemonte per l'Oncologia

No place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy

Place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy

No place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy

Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube

Place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy

Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube

Biming He

Haifeng Wang

This is a randomized controlled and non-inferiority trial in comparison of intraperitoneal laparoscopic radical prostatectomy without drainage tube between intraperitoneal laparoscopic radical prostatectomy with drainage tube in the safety in men with a localized prostate cancer.

This trial is a prospective, single-centre, randomized controlled, and non-inferiority study in which all men with localized prostate cancer. This study aims to determine whether intraperitoneal laparoscopic radical prostatectomy without drainage tube is non-inferior to intraperitoneal laparoscopic radical prostatectomy with drainage tube in the safety in men with a localized prostate cancer.

Evaluation of the Safety of Intraperitoneal Laparoscopic Radical Prostatectomy With or Without Drainage Tube

Evaluation of the Safety of Intraperitoneal Laparoscopic Radical Prostatectomy With or Without Drainage Tube: a Singlecentre, Randomised Controlled, and Non-inferiority Study

Any adverse event according to the Clavien-Dindo classification will be recorded

The difference between postoperative hemoglobin and preoperative hemoglobin

The time between the patient's first time out of bed and the end of the surgical procedure

The first time to eat after the operation, the first time to exit gas after the operation,the first time to defecation after the operation

The ultrasound and CT to detect if there is abdominal effusion and cyst

Behaviors and Mental Disorders

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

All patients had investigated by retrograde cystography after LRP and were grouped according their bladder neck position: Level 0: bladder neck at or above the superior margin of the symphysis pubis (SMSP), Level -1: bladder neck at \<2 cm below SMSP, and Level -2: bladder neck at \>2 cm below SMSP.

bladder neck level on cystography

HannChorng Kuo, M.D.

To investigate the relationship between post-operative bladder neck levels and urodynamic parameters and their effect on urinary incontinence after laparoscopic radical prostatectomy (LRP). Forty-eight consecutive patients undergoing LRP were retrospectively reviewed. All patients had investigated by retrograde cystography after LRP and were grouped according their bladder neck position: Level 0: bladder neck at or above the superior margin of the symphysis pubis (SMSP), Level -1: bladder neck at \<2 cm below SMSP, and Level -2: bladder neck at \>2 cm below SMSP. Urodynamic studies were carried out at baseline, 3 and 6 months post-operatively. Early recovery of urinary continence was defined as no urine leakage or only one pad/day used within 3 months after surgery. Demographic characteristics, changes of urodynamic parameters and continence outcomes were analyzed.

Laparoscopic radical prostatectomy (LRP) is effective in treating localized prostate cancer with good long-term oncological outcomes. Urinary incontinence, which is a bothersome complication with a negative effect on the patient's quality of life, remains a relevant problem after LRP, despite the improvements in the surgical technique. More than 80% of patients undergoing radical prostatectomy encounter urinary incontinence immediately after catheter removal, but the bladder condition can generally stabilize within two years after operation. Among the patients undergoing LRP, persistent urinary incontinence has been reported in 4-30% of patients, and further treatment is often required.

Definite evaluation for the voiding function has been recommended for patients with prolonged post-prostatectomy urinary incontinence (PPI). To improve quality of life after LRP, early recovery of urinary continence is an important concern for patients. Several studies have investigated the predictive factors of early recovery of urinary continence after prostatectomy, including the amount of urine loss after catheter removal, pelvic floor muscle function, a nerve-sparing technique, and the membranous urethral length loss ratio.

Other factors relating to the early recovery of urinary continence include post-operative anatomy of the lower urinary tract, such as the length of the membranous urethra and the level of the vesicourethral junction. However, there has been no consensus on the standard criteria that should be used to measure the structural changes, and the relationship between the urodynamic change and the anatomical morphology remains unclear. In this study, investigators study the relationship between the urodynamic parameters and the bladder neck levels after LRP, and their effects on the early recovery of urinary incontinence.

This study was a retrospective analysis. From 2011 to 2014, a total of 48 consecutive patients with localized prostatic cancer underwent LRP in single medical center by two experienced surgeons. Videourodynamic study was performed before operation (baseline) and at 3 and 6 months after operation. The Ethics Committee of the hospital approved this study and written informed consent was waived because the study was a retrospective analysis. The principles of Helsinki Declaration were followed throughout the study.

The urodynamic parameters were measured and recorded including first sensation of filling (FSF), maximum flow rate (Qmax), detrusor pressure at Qmax (PdetQmax), voided volume, cystometric bladder capacity (CBC), bladder compliance, post-void residual (PVR) volume, maximal urethral closure pressure (MUCP) and functional profile length (FPL). The urodynamic parameters were compared between baseline and different time-points after LRP.

The BN level was evaluated by retrograde cystography, which was routinely performed 7 to 14 days after LRP to evaluate the condition of anastomosis. The image was obtained anteroposteriorly after infusing 100-150 mL of contrast solution into the bladder while the patient was in standing position. The distance between the bladder neck and the superior margin of the symphysis pubis (SMSP) was then measured by the same urologist. The bladder neck level was graded on a three-point scale: a bladder neck level at or above the SMSP was marked as level 0, a bladder neck level with a distance less than 2 cm below the SMSP was marked as level -1, and bladder neck levels 2 or more cm below the SMSP was labeled as level -2.

The patient's urinary continence status was evaluated on direct visits and via questionnaires during follow-up periods at 3, 6, and 12 months post-operatively. Patients without urine leakage in their daily life and those who used only one pad per day for safety reasons without limitation in their daily activities were defined as "urinary continent". Otherwise, the patients were defined as "urinary incontinent". Regaining continence within 3 months after LRP was considered early recovery of urinary continence.

The data was collected retrospectively by chart review. The variables among continent and incontinent patients were evaluated by univariate analysis (t-test for continuous variables and Chi-square for categorical variables ). The ANOVA test was use to compare the urodynamic parameters between different BN levels. Statistical analysis was performed using SPSS 20.0 statistical software.

Predictor of Early Recovery on Urinary Continence After Laparoscopic Radical Prostatectomy

Predictor of Early Recovery on Urinary Continence After Laparoscopic Radical Prostatectomy: Bladder Neck Level and the Association With Urodynamic Parameters

No plan to share data with other researchers

Patients without urine leakage in their daily life and those who used only one pad per day for safety reasons without limitation in their daily activities at 3 months after laparoscopic radical prostatectomy were defined as "urinary continent"

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison H-FIRE and Laparoscopic RP in Treating Men With Localized Prostate Cancer	NCT04278261	Prostate Cancer Treatment	Focal therapy(h... laparoscopic ra...	- 80 Years	Shanghai East Hospital
Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment	NCT04011865	Prostate Cancer	Radical prostat...	18 Years -	Binh Dan Hospital
Study of Peri-Operative Docetaxel Plus Laparoscopic Radical Prostatectomy in Prostate Cancer Patients	NCT00127088	Prostate Cancer	docetaxel laparoscopic ra...	18 Years - 70 Years	Gustave Roussy, Cancer Campus, Grand Paris
Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Laparoscopic Radical Prostatectomy	NCT00511498	Prostate Cancer	Sildenafil	18 Years - 64 Years	Johns Hopkins University
Outpatient Laparoscopic Radical Prostatectomy	NCT05975775	Prostate Cancer	Laparoscopic ra...	18 Years -	GCS Ramsay Santé pour l'Enseignement et la Recherche
Outpatient Laparoscopic Radical Prostatectomy	NCT05975775	Prostate Cancer	Laparoscopic ra...	18 Years -	GCS Ramsay Santé pour l'Enseignement et la Recherche
Comparison H-FIRE and Laparoscopic RP in Treating Men With Localized Prostate Cancer	NCT04278261	Prostate Cancer Treatment	Focal therapy(h... laparoscopic ra...	- 80 Years	Shanghai East Hospital
Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention	NCT06318559	Cancer of Prost...	3D Robot-assist...	40 Years - 99 Years	Fondazione del Piemonte per l'Oncologia
Evaluation of the Safety of Intraperitoneal Laparoscopic Radical Prostatectomy With or Without Drainage Tube	NCT04457882	Prostate Cancer	Intraperitoneal... Intraperitoneal...	18 Years - 85 Years	Shanghai East Hospital
Predictor of Early Recovery on Urinary Continence After Laparoscopic Radical Prostatectomy	NCT03097367	Urinary Inconti...	bladder neck le...	40 Years - 90 Years	Buddhist Tzu Chi General Hospital

Spots Global Cancer Trial Database for laparoscopic radical prostatectomy