Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Blood and Lymph Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Lymphocele

Lymphatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Cysts

PerFix involves suturing the free end of the peritoneal flap left after RARP + ePLND to the pelvic wall near the symphysis of the pubic bones leaving two lateral openings for directing the lymphatic fluid out of the pelvis to the abdominal cavity.

Peritoneal fixation (PerFix)

Standard of care

Vladimir Student, MD, PhD

The PerFix Trial aims to compare the use of peritoneal fixation technique to standard of care (no fixation) during robot-assisted radical prostatectomy with extended pelvic lymph node dissection (RARP + eLND) for the prevention of symptomatic and radiologic lymphocele formation.

Extended pelvic lymph node dissection (ePLND) is the most accurate staging tool to determine lymph node involvement in prostate cancer. As urologist perform this procedure more often now, thanks to the shift to more advanced and aggressive stages, the role of ePLND is expanding. The main complication of PLND is development of a collection of lymphatic fluid called a lymphocele. Lymphoceles can be associated with abdominal pain, lower urinary tract symptoms, bladder outlet obstruction, penile or scrotal edema, infection/sepsis, lower extremity swelling and deep vein thrombosis. They necessitate intervention in up to 10% of patients treated with RARP + ePLND which includes drainage or surgery. Radiologic incidence can be as high as around 50% of operated patients with unknown clinical relevance. Many interventions aimed at reducing the rate of lymphocele formation with limited success so far. Several retrospective studies suggested using peritoneal flap fixation technique which could direct the lymphatic fluid to the peritoneal cavity out of the pelvis and its ensure its reabsorption there. We hypothesize that peritoneal fixation can potentially lower the incidence of symptomatic and radiologic lymphocele formation. By preventing this potentially very dangerous complication, it could be very beneficial for a large group of patients suffering from aggressive localized prostate cancer who are scheduled for RARP + ePLND.

Our goal is to is to test this hypothesis in a randomized trial comparing the fixation technique to standard of care, i.e. no fixation.

Effect of Peritoneal Fixation on Lymphocele Formation

Prospective Randomized Trial Evaluating the Effect of Peritoneal Flap Fixation on Symptomatic and Radiologic Lymphocele Formation Following Robot Assisted Radical Prostatectomy With Extended Pelvic Lymph Node Dissection (PerFix)

The number of participants with symptomatic lymphocele will be determined. Clinical symptoms, time of onset, the size of the lymphocele, location, number of Lymphoceles and intervention needed will be measured

The number of participants with radiologic lymphocele on Pelvic CT scan will be determined together with the size, location and number of detected lymphoceles.

Incidence of adverse events in the Prefix group compared to control group (no PerFix) will be measured. Surgical complications will be evaluated according to Clavien-Dindo classification

The change in lymphocele size during follow-up CT scan will be examined

Radiologic investigation will be done in case of by swelling or pain of the lower extremity and the number of any venous thromboembolism will be determined

Perioperative outcomes (time of the surgery, blood loss and hospital stay) will be measured

The rate of continent patients will be defined using pads needed per day. Continent equals to 0-1 pad per day.

Potency equals to 19 and more points in the International index of erectile function (IIEF5) questionnaire (scale 0-25), the higher the score, the better.

Change in the International prostate symptom score (IPSS) questionnaire from the baseline will be assessed (scale 0-35, higher score means worse outcome).

University Hospital Olomouc

Vladimir Student Jr., MD, PhD, FEBU

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Transitional Cell Carcinoma

Robotic-assisted laparoscopic extended pelvic lymph node dissection

During radical cystectomy, robotic-assisted technique used to perform cystectomy and pelvic lymph node dissections. Each patient will undergo a second-look open lymph node dissection once the incision is made at the end for the urinary diversion.

Robotic-assisted laparoscopic surgery

John W. Davis, MD

The goal of this clinical research study is to evaluate how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made, in patients who are having their bladder removed for the treatment of bladder cancer.

The primary objective is to compare the lymph node yield achieved by performing a robotic-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) compared to a second-look open lymph node dissection (O-PLND) among patients undergoing radical cystectomy for transitional cell carcinoma of the bladder.

The secondary objectives will be to collect prospective outcomes data related to the performance of RA-PLND and robotic-assisted cystectomy (RA-C) including operative times, estimated blood loss, transfusions, complications, return to diet, utilization of pain medication, hospital length, return to regular activities.

Study Background:

Research has shown that the more lymph nodes removed as part of a radical cystectomy (bladder removal) for invasive bladder cancer, the better. However, the number of lymph nodes removed varies from person to person. The standard surgical techniques such as robot-assisted procedures are new, and researchers want to be able to more reliably tell if the specific number of lymph nodes removed is enough to be considered a "complete" removal.

In this study, researchers will remove the required lymph nodes using a standard robotic-assisted procedure, and then remove any additional lymph nodes that remain and need to be removed, using a wider ("open") incision in the abdomen. This open technique is also being done for standard of care. It is needed in order to complete the "urinary diversion" part of the surgery (a procedure of surgically making way for urine to pass out of the body so that it does not go through the bladder).

The main goal of the study is to see if the robotic-assisted procedure removes all of the required lymph nodes. The open technique will allow researchers to evaluate how many lymph nodes were left behind after robotic-assisted removal.

It is possible that the machine may have problems and not be available for use on the scheduled day of surgery. If that happens, you will have the option to reschedule surgery or have standard open surgery. It is also possible that the machine could have problems during your surgery. If that happens, your doctor will continue with standard open surgery. Your study doctor will discuss these possible situations with you.

You will be asked to sign a separate consent form for these surgical procedures, which will describe the procedures and their risks in more detail.

Follow-up:

You will be asked to fill out a brief pain survey once a week for 7 weeks after surgery. The survey will take about 5 minutes to complete. You will also be given a diary to record your daily pain medication use. It will also take about 5 minutes to complete. You will continue to complete the questionnaire once a week and to fill out the diary daily for 6 weeks.

End-of-Study Visit:

You will visit the clinic 6-12 weeks after surgery for an end-of-study visit. You will have a chest x-ray. Your pain medication use and pain level surveys will be collected. After this visit, you will be off-study.

This is an investigational study. The robotic-assisted bladder removal is FDA approved for this purpose. Up to 60 patients will be enrolled in this study. All will be enrolled at The University of Texas (UT) MD Anderson Cancer Center (MDACC).

Robotic-Assisted Laparoscopic Extended Pelvic Lymph Node Dissection for Transitional Cell Carcinoma of the Bladder

Phase II Evaluation of Robotic-assisted Laparoscopic Extended Pelvic Lymph Node Dissection for Transitional Cell Carcinoma of the Bladder

The median yield (the lymph node count) allows for comparison of how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made. Specifically a robot-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) is compared to a second-look open lymph node dissection (O-PLND) among participants undergoing radical cystectomy for urothelial carcinoma of the bladder. The median yield lymph nodes illustrate the adequacy of extended pelvic lymph node dissection using a robotic-assisted technique, i.e. whether the robotic-assisted laparoscopic radical cystectomy yields a sufficient number of lymph nodes to be oncologically equivalent to the open procedure.

The median yield (the lymph node count) allows for comparison of how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made. Specifically a robot-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) is compared to a second-look open lymph node dissection (O-PLND) among participants undergoing radical cystectomy for urothelial carcinoma of the bladder. The median yield lymph nodes illustrates the adequacy of extended pelvic lymph node dissection using a robotic-assisted technique.

M.D. Anderson Cancer Center

Robotic-assisted Laparoscopic Surgery

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

John W. Davis, MD / Assistant Professor

RA-PLND

O-PLND

Median Yield of Robot Assisted and Second Look Open Pelvic Lymph Node Dissection to Compare the Lymph Node Yield Achieved

Overall Percentage Median Yield

Overall Study

Radical prostatectomy with extended pelvic lymph node dissection

ePLND is performed either before or after radical prostatectomy and includes the removal of all nodal and fibro-fatty tissue

Radical prostatectomy (RP) followed by ePLND

Radical prostatectomy (RP) only

Cyrill A. Rentsch, MD-PhD

For patients with intermediate-risk prostate cancer plus a predicted risk of \>5% for positive lymph nodes and with high-risk prostate cancer, international guidelines recommend ePLND along with the RP. Besides an improved accuracy in staging, the therapeutic role of ePLND remains controversial. We hypothesize that ePLND prolongs time to biochemical recurrence (BCR) and prostate cancer-specific survival (PCSS) in intermediate- and high-risk PCa patients.

Radical prostatectomy (RP) is the surgical standard treatment for men with localized prostate cancer (PCa) and a life expectancy of \> 10 years. RP is a treatment option for localized PCa that shows benefit in prostate cancer-specific survival (PCSS) and overall survival compared to conservative management. According to the guideline recommendations of the European Association of Urology (EAU), RP should be accompanied by extended pelvic lymph node dissection (ePLND) in patients with intermediate-risk PCa (D'Amico classification) and \> 5% nomogram (Briganti) predicted risk of positive lymph nodes and in all high-risk PCa cases.

Besides an improved accuracy in staging, the therapeutic role of ePLND remains controversial. The primary goal of this trial is to provide high-level evidence regarding the therapeutic benefit of ePLND in intermediate- and high-risk PCa patients without clinical evidence of nodal involvement. It is hypothesized that ePLND prolongs time to biochemical recurrence (BCR) and prostate cancer-specific survival (PCSS) in intermediate- and high-risk PCa patients.

SAKK 09/18 is an international, multicenter, randomized, phase III surgical intervention trial

Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer

Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer: An International, Multicenter, Randomized Phase III Trial

The primary endpoint of this trial is time to BCR, defined as time from randomization to biochemical recurrence, defined as serum PSA level ≥ 0.2 ng/ml, with a second confirmatory serum PSA level ≥ 0.2 ng/ml. Patients not experiencing an event will be censored at the date of the last available assessment or at the start of adjuvant or salvage treatment, if any.

PSA persistence is defined as failure to reach a PSA value of \<0.1 ng/ml within 12 weeks (+ 2 weeks) postoperatively.

Patients with no assessments within the first 12 weeks (+ 2 weeks) after surgery will be counted as failures for this endpoint

Time to initiation of adjuvant or salvage therapies will be calculated as the time from randomization to the start of any type of adjuvant or salvage therapy. Patients not starting adjuvant or salvage therapies are censored at the last date they were known to be alive.

Time to loco-regional recurrence will be calculated from randomization until local (prostate bed) or regional (extent of ePLND template) recurrence, whichever occurs first. Patients not experiencing an event will be censored at the date of the last available assessment or at the start of adjuvant or salvage therapy, if any.

Time to distant metastasis will be calculated from randomization until first occurrence of distant metastasis. Patients not experiencing an event will be censored at the date of the last available assessment.

PCSS will be calculated as the time from randomization to the date of death due to prostate cancer. Patients who died due to other reasons will be censored at the time of death. All other patients will be censored at the last date they were known to be alive.

Causes of death may require critical review by the coordinating investigator and the medical advisor. Particular attention will be paid to men who have been reported as having died from prostate cancer without previously reported progression or recurrence and men who were reported as having died from non-prostate cancer causes after developing biochemical or clinical progression.

OS will be calculated from randomization until death from any cause. Patients not experiencing an event will be censored at the last date they were known to be alive.

Intraoperative complications will be assessed using the CLASSIC system.

Postoperative complications will be assessed using the Clavien-Dindo classification.

AEs will be assessed according to NCI CTCAE v5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Peritoneal Fixation on Lymphocele Formation	NCT04853095	Prostate Cancer Lymphocele Afte...	Peritoneal fixa... Standard of car...	18 Years -	University Hospital Olomouc
Robotic-Assisted Laparoscopic Extended Pelvic Lymph Node Dissection for Transitional Cell Carcinoma of the Bladder	NCT00963859	Bladder Cancer	Robotic-assiste...	-	M.D. Anderson Cancer Center
Effect of Peritoneal Fixation on Lymphocele Formation	NCT04853095	Prostate Cancer Lymphocele Afte...	Peritoneal fixa... Standard of car...	18 Years -	University Hospital Olomouc
Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer	NCT03921996	Prostate Cancer	Radical prostat... Radical prostat...	18 Years - 80 Years	Swiss Group for Clinical Cancer Research
Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer	NCT03921996	Prostate Cancer	Radical prostat... Radical prostat...	18 Years - 80 Years	Swiss Group for Clinical Cancer Research

Spots Global Cancer Trial Database for extended pelvic lymph node dissection