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Recruitment difficulty
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| Name | Class |
|---|---|
| Merit Medical Systems, Inc. | INDUSTRY |
| Society of Interventional Radiology Foundation | OTHER |
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The purpose of this study is to determine whether pre-operative prostate artery embolization (PAE) reduces intra-operative blood loss and improves surgical outcomes among prostate cancer patients undergoing robot-assisted laparoscopic radical prostatectomy (RALRP).
Duration of study:
This study will enroll 20 patients, with a target enrollment period of 18 months. Patients who undergo prostate artery embolization (PAE) will have follow-up visits 2 weeks and 6 weeks after PAE. All patients in the study will have post RALRP follow-up visits at 2 weeks, 3 months, 6 months, 9 months, and 12 months after surgery. All patients will continue to be followed according to the usual standard of care following the completion of the study.
Study design:
The first 10 patients who meet all study eligibility criteria and provide consent for participation in the study will receive PAE prior to RALRP. Control patients will be matched 1:1 to PAE patients, according to risk score, and will receive RALRP without PAE. Control patients will be selected after all PAE patients have been enrolled, and need not meet all study eligibility criteria.
The following assessments and evaluations are required for participation in this study:
Physical exams, blood & urine tests, magnetic resonance imaging (MRI), digital rectal exams (DREs), transrectal ultrasound (TRUS), Expanded Prostate Cancer Index Composite (EPIC) questionnaires, International Index of Erectile Function (IIEF) questionnaires, robot-assisted laparoscopic radical prostatectomy (RALRP), and pad weight tests. All patients enrolled in the PAE arm of the study will undergo embolization of the blood vessels that feed the prostate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate artery embolization (PAE) | Experimental | 10 patients will receive prostate artery embolization (PAE) prior to robot-assisted laparoscopic radical prostatectomy (RALRP). |
|
| Control | No Intervention | 10 patients, matched to PAE patients by risk score, will receive RALRP without PAE. RALRP without PAE is the current standard of care treatment for prostate cancer at the Sylvester Comprehensive Cancer Center. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostate artery embolization (PAE) | Device | Embolization of the arteries carrying blood to the prostate. All PAE procedures will be conducted with Embosphere Microspheres. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Blood Loss During Robot-assisted Laparoscopic Radical Prostatectomy (RALRP) | Blood loss during the robotic prostatectomy will be estimated by the surgeon performing the procedure. | RALRP procedure, up to 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin Compared to Baseline | Patients will undergo a blood test to assess their hemoglobin level prior to surgery on the day of RALRP, and again on post operative day 1 to determine the change in the hemoglobin level following surgery. | Baseline, RALRP post operative day |
| Change in Hematocrit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shivank Bhatia, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prostate Artery Embolization (PAE) | 10 patients will receive prostate artery embolization (PAE) prior to robot-assisted laparoscopic radical prostatectomy (RALRP). Prostate artery embolization (PAE): Embolization of the arteries carrying blood to the prostate. All PAE procedures will be conducted with Embosphere Microspheres. |
| FG001 | Control | 10 patients, matched to PAE patients by risk score, will receive RALRP without PAE. RALRP without PAE is the current standard of care treatment for prostate cancer at the Sylvester Comprehensive Cancer Center. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
subject analyzed in PAE arm 4. 0 subject analyzed in the control arm
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| ID | Title | Description |
|---|---|---|
| BG000 | Prostate Artery Embolization (PAE) | 10 patients will receive prostate artery embolization (PAE) prior to robot-assisted laparoscopic radical prostatectomy (RALRP). Prostate artery embolization (PAE): Embolization of the arteries carrying blood to the prostate. All PAE procedures will be conducted with Embosphere Microspheres. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Estimated Blood Loss During Robot-assisted Laparoscopic Radical Prostatectomy (RALRP) | Blood loss during the robotic prostatectomy will be estimated by the surgeon performing the procedure. | Posted | Mean | Standard Deviation | mL | RALRP procedure, up to 3 hours |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prostate Artery Embolization (PAE) | 10 patients will receive prostate artery embolization (PAE) prior to robot-assisted laparoscopic radical prostatectomy (RALRP). Prostate artery embolization (PAE): Embolization of the arteries carrying blood to the prostate. All PAE procedures will be conducted with Embosphere Microspheres. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular Arrhythmia | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shivank Bhatia | University of Miami | 305-243-7500 | sbhatia1@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2016 | Sep 5, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Patients will undergo a blood test to assess their hematocrit prior to surgery on the day of RALRP, and again on post operative day 1 to determine the change in the hematocrit following surgery. |
| Baseline, RALRP post operative day 1 |
| Change in Prostate Volume | Patients who receive PAE will undergo MRIs before PAE and 6 weeks after PAE to assess any change in prostate volume following the embolization procedure. | Baseline, 6 weeks post PAE |
| Number of Patients That Required Blood Transfusion | Requirement for blood transfusion during the prostatectomy procedure will be assessed in all patients. The surgeon performing the prostatectomy will determine whether or not patients require blood transfusions. | RALRP procedure |
| RALRP Duration | RALRP procedure |
| Length of Hospital Stay After RALRP | 48 hours post procedure |
| Number of Participants for Whom Prostatectomy Procedure Did Not Succeed in Removing the Entire Cancer | Histopathology examination post RALRP will be used to determine if the prostatectomy procedure succeeded in removing the entire cancer. | RALRP procedure |
| Biochemical Recurrence of Prostate Cancer | Biochemical recurrence of prostate cancer will be determined by PSA levels 1 year following the RALRP procedure. | 1 year post RALRP |
| Return to Continence | Return to continence following the RALRP procedure will be determined by the pad weight test, conducted at each follow-up visit until the patient is continent. | An expected average of 1 week post RALRP |
| RALRP-related Adverse Events | Any adverse event occurring between the date of RALRP and 1 year of follow-up that the investigators determine to be related to the RALRP procedure will be assessed. | Through 1 year post RALRP |
| PAE-related Adverse Events | Any adverse event occurring between the date of PAE and 1 year of follow-up that the investigators determine to be related to the PAE procedure will be assessed. | Through 1 year post RALRP |
| Change From Baseline in Erectile Function at One Year Post RALRP | The International Index of Erectile Function (IIEF) questionnaire is a multi-dimensional self-administered test found to be used in the clinical assessment of erectile dysfunction. It examines the 4 main domains of male sexual function. A higher score would indicated less dysfunction. The scores can range 6 to 75 | Baseline,1 year post RALRP |
| Change in PSA Following PAE | Patients who undergo PAE will have blood tests to determine the change in their PSA levels between baseline and 6 weeks post PAE. | 6 weeks post PAE |
| Histologic Changes in the Prostate After PAE | The Gleason Score prostate Cancer Grading and Prognostic scoring system will be used to determine the histologic changes in the prostate tumor. Since prostate tumors are often made up of cancerous cells that have different grades, two grades are assigned to each patient. A primary grade is given to describe the cells that make up the largest area of the tumor and a secondary grade is given to describe the cells of the next largest area. The sums of the scores will be evaluated. The Gleason Score sum will range from 1 - 10, with the higher score indicating a more advanced neoplasm. | Between baseline prostate biopsy and RALRP |
| Control |
10 patients, matched to PAE patients by risk score, will receive RALRP without PAE. RALRP without PAE is the current standard of care treatment for prostate cancer at the Sylvester Comprehensive Cancer Center. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Change in Hemoglobin Compared to Baseline | Patients will undergo a blood test to assess their hemoglobin level prior to surgery on the day of RALRP, and again on post operative day 1 to determine the change in the hemoglobin level following surgery. | Posted | Mean | Standard Deviation | G/DL | Baseline, RALRP post operative day |
|
|
|
| Secondary | Change in Hematocrit | Patients will undergo a blood test to assess their hematocrit prior to surgery on the day of RALRP, and again on post operative day 1 to determine the change in the hematocrit following surgery. | Posted | Mean | Standard Deviation | percentage of red blood cells | Baseline, RALRP post operative day 1 |
|
|
|
| Secondary | Change in Prostate Volume | Patients who receive PAE will undergo MRIs before PAE and 6 weeks after PAE to assess any change in prostate volume following the embolization procedure. | Posted | Mean | Standard Deviation | cc | Baseline, 6 weeks post PAE |
|
|
|
| Secondary | Number of Patients That Required Blood Transfusion | Requirement for blood transfusion during the prostatectomy procedure will be assessed in all patients. The surgeon performing the prostatectomy will determine whether or not patients require blood transfusions. | Posted | Number | participants | RALRP procedure |
|
|
|
| Secondary | RALRP Duration | Posted | Mean | Standard Deviation | hr | RALRP procedure |
|
|
|
| Secondary | Length of Hospital Stay After RALRP | Posted | Median | Standard Deviation | Days | 48 hours post procedure |
|
|
|
| Secondary | Number of Participants for Whom Prostatectomy Procedure Did Not Succeed in Removing the Entire Cancer | Histopathology examination post RALRP will be used to determine if the prostatectomy procedure succeeded in removing the entire cancer. | Posted | Count of Participants | Participants | RALRP procedure |
|
|
|
| Secondary | Biochemical Recurrence of Prostate Cancer | Biochemical recurrence of prostate cancer will be determined by PSA levels 1 year following the RALRP procedure. | Posted | Mean | Standard Deviation | ng/mL | 1 year post RALRP |
|
|
|
| Secondary | Return to Continence | Return to continence following the RALRP procedure will be determined by the pad weight test, conducted at each follow-up visit until the patient is continent. | Posted | Mean | Standard Deviation | grams | An expected average of 1 week post RALRP |
|
|
|
| Secondary | RALRP-related Adverse Events | Any adverse event occurring between the date of RALRP and 1 year of follow-up that the investigators determine to be related to the RALRP procedure will be assessed. | Posted | Number | adverse events | Through 1 year post RALRP |
|
|
|
| Secondary | PAE-related Adverse Events | Any adverse event occurring between the date of PAE and 1 year of follow-up that the investigators determine to be related to the PAE procedure will be assessed. | Posted | Number | adverse events | Through 1 year post RALRP |
|
|
|
| Secondary | Change From Baseline in Erectile Function at One Year Post RALRP | The International Index of Erectile Function (IIEF) questionnaire is a multi-dimensional self-administered test found to be used in the clinical assessment of erectile dysfunction. It examines the 4 main domains of male sexual function. A higher score would indicated less dysfunction. The scores can range 6 to 75 | Posted | Mean | Standard Deviation | Score on a scale | Baseline,1 year post RALRP |
|
|
|
| Secondary | Change in PSA Following PAE | Patients who undergo PAE will have blood tests to determine the change in their PSA levels between baseline and 6 weeks post PAE. | Posted | Mean | Standard Deviation | ng/mL | 6 weeks post PAE |
|
|
|
| Secondary | Histologic Changes in the Prostate After PAE | The Gleason Score prostate Cancer Grading and Prognostic scoring system will be used to determine the histologic changes in the prostate tumor. Since prostate tumors are often made up of cancerous cells that have different grades, two grades are assigned to each patient. A primary grade is given to describe the cells that make up the largest area of the tumor and a secondary grade is given to describe the cells of the next largest area. The sums of the scores will be evaluated. The Gleason Score sum will range from 1 - 10, with the higher score indicating a more advanced neoplasm. | Posted | Mean | Standard Deviation | Units on a scale | Between baseline prostate biopsy and RALRP |
|
|
|
| 0 |
| 4 |
| 1 |
| 4 |
| 4 |
| 4 |
| Urinary Urgency | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cystitis | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Bladder Spasm | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Flu Like Symptoms | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nausea | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Edema Limbs | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Wound Complication | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Acute Kidney injury | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Hematoma | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |