Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Prostatic Neoplasms

Dehydration

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.

Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.

Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP, and before the urethrovesical anastomosis. The membrane will cut into two longitudinal pieces and it will be placed over each neurovascular bundle separately.

Amniotic Membrane Placement

Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.

EPIC 26

Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.

PSA Measurement

SHIM psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.

Sexual History Inventory for Men

Sanoj Punnen, MD

The use of dehydrated human amnionic membrane allograft improves erectile function recovery (as measured by (Sexual History Inventory for Men (SHIM) score) at 12 months after robotic assisted radical prostatectomy (RARP) compared to a control group with no allograft.

This is a phase 2 prospective randomized trial investigating the impact of amniotic membrane placement over the neurovascular bundles after bilateral nerve sparing robot assisted radical prostatectomy on potency. The study will have a control arm that will follow standard of care surgery, without placement of any membranes. 70 men will be allocated to each arm.

The research study will involve follow up every 3 months for the first 12 months. After this the investigators will follow patients annually with prostate-specific antigen (PSA) measurements and an assessment of any secondary therapies for 5 years post-surgery.

Randomization of study patients will be done in equal proportion to Arm I (membrane placement) and Arm II (no membrane placement, standard of care surgery) using a permuted block design stratified by baseline SHIM score (\<17 vs. \>=17), and use of ANY erectile aids (Yes vs. No) in the last 3 months.

Participants will not know their treatment arm assignment until after robotic assisted radical prostatectomy (RARP) surgery.

Miami Membrane for Potency (MMEP) Trial

Miami Membrane for Potency (MMeP) Trial to Assess the Impact of Dehydrated Human Amnion Membrane Allograft Placement During Robotic Radical Prostatectomy on Early Return of Erectile Function

The difference in average change in Sexual History Inventory for Men (SHIM) score, between baseline and 12 months post RARP between the membrane and control arms will be assessed as the primary endpoint. The SHIM score is measured in points on a scale: The minimum score is 5 to 7 indicating severe erectile dysfunction (ED), the maximum score is 22 to 25, indicating no ED.

Among men with a SHIM greater than or equal to 17 at baseline, the investigators will compare the proportion of men in each group with mild ED or better, defined by a SHIM greater than or equal to 17, at 3, 6, 9 and 12 months post RARP.

Among men with a SHIM greater than or equal to 17 at baseline, the investigators will compare the proportion of men in each group who are able to achieve an erection sufficient for intercourse more than 50% of the time at 3, 6, 9 and 12 months post RARP.

Among men with a SHIM greater than or equal to 17 at baseline, the investigators will evaluate the proportion of men who require the use of more invasive erectile aids (intra-cavernosal injection, vacuum pump, or penile prosthesis) at 3, 6, 9, and 12 months post RARP.

Rates of urinary control as measured by no pads per day at 3, 6, 9, and 12 months,

Rate of prostate cancer recurrence in study participants in both study arms at 5 years post-radical prostatectomy.

Vivex Biomedical

University of Miami

Associate Professor of Clinical

Per protocol, non-serious adverse events (AEs) were only monitored, assessed and recorded if they were attributed to the membrane placement during the RARP procedure.

Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.

Amniotic Membrane Placement: Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP, and before the urethrovesical anastomosis. The membrane will cut into two longitudinal pieces and it will be placed over each neurovascular bundle separately.

EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.

PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.

SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.

Arm 1 - Amniotic Membrane Placement

Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.

EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.

PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.

SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.

Arm 2 - No Amniotic Membrane Placement

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Sexual History Inventory for Men (SHIM) psychosocial questionnaire. The SHIM score measures the severity of the participant's Erectile Dysfunction (ED) in points on a scale as follows:

* 22 - 25: No significant erectile dysfunction
* 17 - 21: Mild erectile dysfunction
* 12 - 16: Mild-to-moderate erectile dysfunction
* 8 - 11: Moderate erectile dysfunction
* 5 - 7: Severe erectile dysfunction

SHIM Score

A measure of the amount of prostate-specific antigen (PSA) in the blood.

PSA Level

Due to early study termination, not all study participants completed scheduled visits.

Sanoj Punnen MD, MAS

The Difference in Average Change in SHIM Score, Between Baseline and 12-Months Post-RARP, of Study Participants in Each Group

Mild or Better ED, Baseline

Mild or Better ED, 3 months

Mild or Better ED, 6 months

Mild or Better ED, 9 months

Mild or Better ED, 12 months

Participants with a SHIM score of greater than or equal to 17 at baseline. Due to early study termination, not all study participants completed scheduled visits.

Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP

3 months

6 months

9 months

12 months

Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP.

3 months Post-RARP

6 months Post-RARP

9 months Post-RARP

12 months Post-RARP

Arm 1: Amniotic Membrane Placement

Arm 2: No Amniotic Membrane Placement

Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP

No Pad Usage: Baseline

No Pad Usage: 3 months post-RARP

No Pad Usage: 6 months Post-RARP

No Pad Usage: 9 months Post-RARP

No Pad Usage: 12 months Post-RARP

Rates of Urinary Control Experienced by Study Participants

Data were not collected due to early termination of study.

5-year Rate of Prostate Cancer Recurrence Between Both Study Arms

Overall Study

All Drugs and Chemicals

Androgens

Hormones

Hormone Antagonists

Radical prostatectomy + extended pelvic lymph node dissection according to EAU guidelines followed by stereotactic body radiotherapy to osseous lesions with six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist.

Radical prostatectomy + extended pelvic lymph node dissection

RARP

Stereotactic body radiotherapy to osseous lesions

SBRT

six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist.

Peter B Østergren, MD

Peter B Østergren

A prospective, open label phase 2 clinical trial assessing safety, complications and feasibility of radical prostatectomy (RARP) plus local stereotactic body radiotherapy (SBRT) to bone metastases in combination with short-term medical castration to a select population of prostate cancer patients with oligometastatic disease.

National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients

Oligomet-DK. National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients

Time to castrate resistance (TCR) measured from the primary initiation of ADT to Castrate Resistant Prostate Cancer (CRPC) defined as: Three consecutive rises in PSA one week apart resulting in two 50% increases over the nadir, with PSA \> 1 ng/mL or the appearance of two or more new bone lesions on bone scan or enlargement of a soft tissue lesion using RECIST. At the same time serum testosterone is \<50ng/dL (\<1.70 nnmol/L).

Changes in Quality of life assessed by the questionaire FACT-P-DK and calculated using the FACT-P Scoring Guidelines (Version 4). The following scores will be evaluated:

1. FACT-P Trial Outcome Index (TOI). Score range: 0-104 (The higher score the better). Combines the subscales "Physical well-being", "Functional Well-being" and "Prostate Cancer Subscale"
2. FACT-G total score. Score range: 0-108 (the higher score the better QoL). Combines the subscales: "Physical well-being", "Social well-being", "Emotional well-being" and "Functional well-being".
3. FACT-P total score. Score range: 0-156 (the higher score the better QoL). Combines the subscales: "Physical well-being", "Social well-being", "Emotional well-being", "Prostate Cancer Subscale" and "Functional well-being".

Number of participants undergoing with interventions on lower or upper urinary tract, i.e.:

* Bladder catheter
* Ureteric stent
* Nephrostomy
* Transurethral resection of the prostate (TURP) or related procedure

Proportion of men with Grade ≥ 3 adverse events the first year

Proportion of men achieving prostatic specific antigen (PSA) \< 0.1 ng/ml

Feasibility of radical prostatectomy in the oligometastatic setting measured as number of patients who successfully undergo radical prostatectomy with pelvic lymphnode disection and 30 days (post-operative) morbidity according to the Clavian Dindo Classification.

Peter Busch Østergren

Principal Investigator

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Respiratory Tract Infections

Lymphocele

Cysts

Lymphatic Diseases

Coagulants

Hemostatics

Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.

Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue.

J-Plasma

Vipul R Patel, MD

This study protocol will evaluate the efficacy of Bovie Medical's J-Plasma® helium based plasma technology in the reduction of lymphoceles following pelvic lymph node dissection (PLND) during robotic assisted radical prostatectomy (RARP). The J-Plasma® handpiece will be used during the PLND by dissecting the lymph nodes and sealing the lymphatic channels to prevent lymph leakage.

Participants evaluated and scheduled for a PLND during Robotic Assisted Radical Prostatectomy who have met the study inclusion criteria and who have also given informed consent will be enrolled. Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels. An abdominal-pelvic ultrasound will be completed at a follow-up period ranging from 4-12 weeks post operatively to determine if a lymphocele is present. The occurrence rate of lymphoceles in this trial group will be compared to retrospective data from the principal investigator's practice and other published data to determine if the occurrence rate has been reduced.

Cold Plasma for the Reduction of Lymphoceles Following PLND

Application of Cold Plasma Energy for Reduction of Lymphoceles Following Pelvic Lymph Node Dissection During Robot-Assisted Radical Prostatectomy

The primary outcome to be measured will be the incidence of lymphocele formation as diagnosed upon post- operative abdominal ultrasound.

AdventHealth

Apyx Medical

Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.

J-Plasma: Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue.

Pre-Op Prostate-Specific Antigen (PSA)

Gleason scores range from 2 to 10, and most prostate cancer will score 6 or higher. A higher score (8 to 10) means the type of cancer has a higher risk of growing and spreading.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Miami Membrane for Potency (MMEP) Trial	NCT02710422	Prostate Cancer	Amniotic Membra... EPIC 26 PSA Measurement Sexual History ...	40 Years - 80 Years	University of Miami
National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients	NCT04086290	Prostate Cancer...	RARP SBRT ADT	18 Years -	Herlev Hospital
Cold Plasma for the Reduction of Lymphoceles Following PLND	NCT02658851	Lymphoceles Fol...	J-Plasma	18 Years - 80 Years	Apyx Medical
National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients	NCT04086290	Prostate Cancer...	RARP SBRT ADT	18 Years -	Herlev Hospital
Miami Membrane for Potency (MMEP) Trial	NCT02710422	Prostate Cancer	Amniotic Membra... EPIC 26 PSA Measurement Sexual History ...	40 Years - 80 Years	University of Miami

Spots Global Cancer Trial Database for rarp

Every month we try and update this database with for rarp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rarp

Every month we try and update this database with for rarp cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rarp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.