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

Radical prostatectomy

Antti Kaipia, M.D., Ph.D.

A randomized, prospective study to compare the direct and indirect costs, functional and oncologic results of 3D laparoscopic and robot assisted radical prostatectomy procedures.

The direct and indirect costs, functional and oncologic results of robot assisted radical prostatectomy (RALP) are compared to those of 3D laparoscopic radical prostatectomy. The hypothesis of the study is that the functional and oncologic results of the two operative methods are equal, but the direct costs of RAPL are significantly higher. A randomized, prospective non-inferiority study will will enroll 280 patients randomized 1:1 to both operative approaches to test this hypothesis. The primary functional outcome measure is the proportion of patients with complete urinary continence (no protective pad use) at 12 months post operatively. Secondary functional outcome measure is the preservation erectile function at 12 months post operatively. Oncologic outcome measures are the proportion of patients with undetectable post operative prostate specific antigen levels and positive surgical margins at pathological examination. The direct and indirect costs of both operative approaches are recorded.

3D Versus Robot Assisted Laparoscopic Prostatectomy.

3D Versus Robot Assisted Laparoscopic Prostatectomy. A Prospective Randomized Non-inferiority Study.

Patient demographic, primary and secondary outcome measures available upon request.

Direct and indirect treatment related costs.

Expanded Prostate Cancer Index Composite (EPIC) Short Form (EPIC-26), urinary domain score is used to assess the return of continence post operatively. The percentage of patients with no protective pad use at 12 months post operatively is the main outcome measure.

International Index of Erectile Function (IIEF-5) Questionnaire score is used to quantify the return of erectile function post operatively.

Post operative prostate specific antigen levels.

The oncological outcome is evaluated by the presence of cancerous tissue at the surgical margins of the specimen at pathologic examination.

Seinajoki Central Hospital

Tampere University Hospital

Chief physician, department of urology

Behaviors and Mental Disorders

Erectile Dysfunction

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Patients receive daily vacuum therapy over 10 minutes while holding erection for 2 minutes after undergoing RALP. Patients complete erection process 5 times. SHIM questionnaire administration will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.

Patients receive daily vacuum therapy over 10 minutes while holding erection for 5 minutes after undergoing RALP. Patients complete erection process 2 times.Patients complete erection process 5 times. SHIM questionnaire administration will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.

Questionnaire will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.

Sexual Health Inventory for Men (SHIM) questionnaire administration

management of therapy complications

Patients randomized to Group A or Group B following removal of catheter at first post op visit following surger. Daily vacuum therapy for approximately 10 minutes. Depending on which group randomized to erection held for 2 minutes or 5 mintues.

Daily vacuum therapy

Ronney Abaza, MD

The purpose of this study is to determine which technique in using a vacuum erection device (VED) is best. Erectile dysfunction (ED) after robotic prostate cancer surgery is a concern for both the surgeon and the patient. Recent studies have shown that beginning to use the vacuum pump on a daily basis starting with in 2-8 weeks may help prevent the start of penile shrinkage. This is a potential issue that can occur because of decreased blood flow after prostate cancer surgery. This study will allow researchers to determine and compare vacuum therapy techniques and erectile function outcomes of patients who have prostate cancer surgery

PRIMARY OBJECTIVES:

I. Determine sexual function and penile morphometric outcomes for the post-robotic-assisted laparoscopic prostatectomy (RALP) patients undergoing daily vacuum therapy using one of two randomized methods and whether these outcomes differ.

SECONDARY OBJECTIVES:

I. Compare compliance rates between the two randomized groups using the compliance questionnaire and a diary collected from patients at each follow up visit.

II. Compare overall patient satisfaction with the recovery procedure between the two randomized groups utilizing the SHIM (Sexual Health Inventory for Men) questionnaire.

OUTLINE: Patients are randomized to 1 of 2 treatment groups.

GROUP A: Patients receive vacuum therapy daily over 10 minutes while holding erection for 2 minutes after undergoing RALP. Patients complete erection process 5 times.

GROUP B: Patients receive vacuum therapy daily over 10 minutes while holding erection for 5 minutes after undergoing RALP. Patients complete erection process 2 times.

After completion of study treatment, patients are followed up at 3, 6, and 12 months.

Vacuum Erection Device in Improving Recovery of Erectile Function in Patients With Prostate Cancer Undergoing Surgery

Analysis of Technique Comparison With a Vacuum Erection Device as Part of an Erectile Rehabilitation Program Following Robotic Radical Prostatectomy: A Randomized Comparison of Methodology

Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time.

Summarized according to assigned treatment group.

Ohio State University Comprehensive Cancer Center

Antineoplastic Agents

All Drugs and Chemicals

Genistein

Protective Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

Phytoestrogens

Estrogens

Hormones

Hormone Antagonists

Capsule, 30 mg, oral daily for 3 to 6 weeks

Placebo

Steinar J Karlsen, MD, PhD

Bato Lazarevic, MD

The purpose of this study is to evaluate safety and mechanisms of possible chemopreventive effects of synthetic genistein (BONISTEIN™) in patients with localized prostate cancer undergoing laparoscopic radical prostatectomy.

In Norway prostate cancer is the most frequently diagnosed cancer in the male and represents the second most common cause of cancer death among men. Epidemiological studies have shown an association between decreased prostate cancer risk and increased soy consumption. Genistein is the dominating plasma and tissue isoflavone in soybean products, and it has been attributed several anti-cancer effects. BONISTEIN™ is a novel product, consisting of \>99,5 % synthetic Genistein aglycone. Chemoprevention is the ability of certain molecules to inhibit (partially or totally) induction or progression of the disease. Our study population consists of men diagnosed with localized prostate cancer who have agreed to undergo radical prostatectomy. This provides adequate amount of benign, premalignant and malignant tissue for studying the effects of potential chemopreventive agents on biomarkers of cell growth and differentiation in the prostatic tissues with immunohistochemistry. Prostatic tissue cells will also be selected with Lacer Capture Microdissection (LCM) before analysis with semi-quantitative RT-PCR.

Synthetic Genistein (BONISTEIN™) in Patients Who Are Undergoing Surgery for Prostate Cancer

Effects of Synthetic Genistein Supplementation on Blood and Tissue Biomarkers in Patients With Localized Prostate Cancer

University Hospital, Aker

Bato Lazarevic MD

Symptoms and General Pathology

Nervous System Diseases

Pain, Postoperative

Pain

Postoperative Complications

Neurologic Manifestations

Central Nervous System Depressants

Anesthetics

Ropivacaine

Anesthetics, Local

Bilateral, ultrasound - guided Quadratus Lumborum Block

Qadratus Lumborum Block

30 milliliters of 0.375% Ropivacaine used for Quadratus Lumborum Block

30 milliliters of 0.375% Ropivacaine

30 milliliters of 0.9% NaCl used for Quadratus Lumborum Block

30 milliliters of 0.9% NaCl

Malgorzata Malec-Milewska, MD, PhD

Laparoscopic prostatectomy (LP) is characterized by substantial tissue trauma, despite its minimally -invasive approach. Although postoperative pain intensity is lower when compared to open procedures, the use of opioids is common. Retrospective review of available LP cases revealed that although analgesic demand varied, nearly all of our LP patients required opioids postoperatively. Bilateral Quadratus Lumborum Block (QLB), being one of relatively new features of regional anesthesia, offers good analgesia of abdominal wall, with the potential for control of visceral pain. This study was established to evaluate its effectiveness in alleviating pain after radical prostatectomy in a double - blind, placebo - controlled manner.

Double blind, placebo-controlled, randomised

Solution used for block (local anesthetic or placebo) is known to anesthetist not involved in patient's care.

Qudratus Lumborum Block for Postoperative Pain After Endoscopic Prostatectomy.

Ultrasound-guided Quadratus Lumborum Block for Postoperative Pain Control After Endoscopic Prostatectomy - Double Blinded, Placebo-controlled, Randomised Trial.

Oxycodone consumption with Patient-Controlled Analgesia pump

Pain scores assessed with Numeric Rating Scale (NRS).In this scale pain intensity is expressed using one of the numbers 0 - 10, 0 being no pain and 10 worst pain imaginable.

Time in minutes from emergence from anesthesia to the first request for opioid

The occurence of symptoms and conditions related to the use of opioids, like nausea, ileus, itching

Centre of Postgraduate Medical Education

Micronutrients

Hematinics

Vitamins

Other Dietary Supplements

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Indole

Patients with risk of EPE and having robotic prostatectomy for prostate cancer.

Cytalux™ (pafolacianine) injection: folate analog ligand conjugated with an indole cyanine green-like dye for real-time cancer margin status.

This is used in conjunction with appropriate imaging system.

Cytalux™ (pafolacianine) for fluorescent imaging

Jennifer Lehman, RN

Jennifer Lehman

Clinton Bahler, MD

This study is being done to compare how much using Cytalux™ (pafolacianine) with NIR (Near InfraRed) fluorescent imaging improves the detection of malignant (growing in an uncontrolled way) tissue in adult subjects undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.

The U.S. Food and Drug Administration (FDA) has approved the targeted imaging agent pafolacianine (Cytalux) for use in ovarian cancer (2021) and lung cancer surgery (2022.)

This is an open label trial in up to 15 subjects with biopsy confirmed prostate cancer (PCa) who have been scheduled to undergo a laparoscopic radical prostatectomy with or without robotic assistance, with pelvic lymph node dissection. This is a non-intervention trial to assess the accuracy of an imaging agent, folate targeted fluorescent dye (pafolacianine), during a standard of care radical prostatectomy.

Qualifying subjects will be Grade Group 3 to 5 (\>/= cT3) with either suspected extraprostatic disease (EPD) (extracapsular extension (ECE) and/or seminal vesicle infiltration (SVI)), or suspected lymph node metastasis (clinical stage cN1, or by magnetic resonance imaging (mriN+), or by Prostate Specific Membrane Antigen positron emission tomography (PSMA PET+).

Whether using an anterior or a posterior approach, the tissues planned for removal will be visualized first under normal light, and their locations marked on a provided template. All additional suspicious tissue or nodes will be similarly marked, whether removed or not. Prior to removal, the field must be illuminated with Near Infrared light (NIR) and fluorescent tissues must be marked on the template. This may proceed in an iterative fashion, switching from first normal light to NIR as the surgical field expands.

NIR imaging must be conducted in the timeframe of one hour to twenty-four hours following IV infusion of pafolacianine. Lymphatics to be examined are, at a minimum, the external iliac, internal iliac and obturator fossa, and common iliac. Fluorescence positive nodules and nodes will be removed at the surgeon's discretion and sent as labeled (specimen number, tissue, location) specimens to pathology without designation of florescence. Ink dots should ideally be applied to the spot suspected of being cancerous.

CYTALUX™for the Intraoperative Imaging of Prostate Cancer

An Investigator Sponsored Study to Investigate the Safety and Efficacy of CYTALUX™ (PAFOLACIANINE) INJECTION for the Intraoperative Imaging of Prostate Cancer

The proportion of subjects who have a Clinically Significant Event (CSE). A CSE is a composite endpoint defined as at least one of the following outcomes:

1. One or more resected "NIR only" positive lymph nodes that contain metastatic disease as confirmed by pathology.
2. Histologically confirmed cancer in resected "NIR only" residual non-nodal soft tissue following prostatectomy.

To evaluate the proportion of subjects whose surgical procedure changed in scope from the planned surgery based on the use of

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
3D Versus Robot Assisted Laparoscopic Prostatectomy.	NCT03550040	Prostate Cancer	Radical prostat...	34 Years - 74 Years	Tampere University Hospital
Vacuum Erection Device in Improving Recovery of Erectile Function in Patients With Prostate Cancer Undergoing Surgery	NCT01660152	Male Erectile D... Prostate Cancer Sexual Dysfunct...	Sexual Health I... management of t... Daily vacuum th...	- 70 Years	Ohio State University Comprehensive Cancer Center
Synthetic Genistein (BONISTEIN™) in Patients Who Are Undergoing Surgery for Prostate Cancer	NCT00546039	Prostatic Neopl...	Genistein Placebo	18 Years -	University Hospital, Aker
Qudratus Lumborum Block for Postoperative Pain After Endoscopic Prostatectomy.	NCT03600129	Prostate Cancer	Qadratus Lumbor... 30 milliliters ... 30 milliliters ...	40 Years - 80 Years	Centre of Postgraduate Medical Education
3D Versus Robot Assisted Laparoscopic Prostatectomy.	NCT03550040	Prostate Cancer	Radical prostat...	34 Years - 74 Years	Tampere University Hospital
Synthetic Genistein (BONISTEIN™) in Patients Who Are Undergoing Surgery for Prostate Cancer	NCT00546039	Prostatic Neopl...	Genistein Placebo	18 Years -	University Hospital, Aker
Qudratus Lumborum Block for Postoperative Pain After Endoscopic Prostatectomy.	NCT03600129	Prostate Cancer	Qadratus Lumbor... 30 milliliters ... 30 milliliters ...	40 Years - 80 Years	Centre of Postgraduate Medical Education
CYTALUX™for the Intraoperative Imaging of Prostate Cancer	NCT06434909	Prostate Cancer	Cytalux™ (pafol...	18 Years - 90 Years	Indiana University

Spots Global Cancer Trial Database for laparoscopic prostatectomy