Prostate Cancer
Conditions
Keywords
Prostate cancer, Prostate artery embolization, Robot-assisted laparoscopic radical prostatectomy
Brief summary
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).
Detailed description
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.
Interventions
Embolization of the arteries carrying blood to the prostate. All PAE procedures will be conducted with Embosphere Microspheres.
Sponsors
Merit Medical Systems, Inc.
Society of Interventional Radiology Foundation
Shivank Bhatia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Patient is 45-79 years old * Patient has signed informed consent * Patient has biopsy-proven prostate adenocarcinoma with localized disease * Patient is a candidate for robot-assisted laparoscopic radical prostatectomy (RALRP) * Patient has a prostate size \>40 grams
Exclusion criteria
* Active urinary tract infection * History of life threatening allergy to iodinated contrast agents * Any known condition that limits catheter-based intervention or is a contraindication to embolization (eg shunt or adverse arterial anatomy) * Patient is unable to undergo MRI imaging * Cardiac condition including congestive heart failure or uncontrolled arrhythmia, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression which required hospitalization within the previous 6 months * Baseline serum creatinine level \> 1.8 mg/dL * Baseline hemoglobin \< 8.0 g/dL * Active cystolithiasis or prostatitis * History of pelvic irradiation or radical pelvic surgery * Known major iliac arterial occlusive disease * Confirmed or suspected bladder cancer * Urethral strictures, bladder neck contracture, or other bladder or urethral pathology that could limit catheterization * Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy or patient evaluation may potentially cause injury to sites of previous rectal surgery, e.g. if a transrectal probe is used * Previous pelvic irradiation or radical pelvic surgery * Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate * Prior transurethral resection of the prostate or other invasive therapies * Coagulation disturbances not normalized by medical treatment * Acute urinary retention * Hypersensitivity to gelatin products * Any contraindication to embolization, including intolerance to vessel occlusion procedures, vascular anatomy/blood flow that precludes catheter placement or embolic agent injection, presence/likely onset of vasospasm, presence/likely onset of hemorrhage, severe atheromatous disease, feeding arteries smaller than distal branches, arteriovenous shunt, and collateral vessel pathways endangering normal territories during embolization or pelvic inflammatory disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Blood Loss During Robot-assisted Laparoscopic Radical Prostatectomy (RALRP) | RALRP procedure, up to 3 hours | Blood loss during the robotic prostatectomy will be estimated by the surgeon performing the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hematocrit | Baseline, RALRP post operative day 1 | 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. |
| Change in Prostate Volume | Baseline, 6 weeks post PAE | 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. |
| Number of Patients That Required Blood Transfusion | RALRP procedure | 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 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 | RALRP procedure | Histopathology examination post RALRP will be used to determine if the prostatectomy procedure succeeded in removing the entire cancer. |
| Change in Hemoglobin Compared to Baseline | Baseline, RALRP post operative day | 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. |
| Return to Continence | An expected average of 1 week post RALRP | 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. |
| RALRP-related Adverse Events | Through 1 year post RALRP | 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. |
| PAE-related Adverse Events | Through 1 year post RALRP | 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. |
| Change From Baseline in Erectile Function at One Year Post RALRP | Baseline,1 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 |
| Change in PSA Following PAE | 6 weeks post PAE | Patients who undergo PAE will have blood tests to determine the change in their PSA levels between baseline and 6 weeks post PAE. |
| Histologic Changes in the Prostate After PAE | Between baseline prostate biopsy and RALRP | 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. |
| Biochemical Recurrence of Prostate Cancer | 1 year post RALRP | Biochemical recurrence of prostate cancer will be determined by PSA levels 1 year following the RALRP procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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. | 0 |
| Total | 4 |
Baseline characteristics
| Characteristic | Prostate Artery Embolization (PAE) | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 0 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 4 Participants | 0 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 4 / 4 |
| serious Total, serious adverse events | 1 / 4 |
Outcome results
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.
Time frame: RALRP procedure, up to 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prostate Artery Embolization (PAE) | Estimated Blood Loss During Robot-assisted Laparoscopic Radical Prostatectomy (RALRP) | 110 mL | Standard Deviation 10 |
Secondary
Biochemical Recurrence of Prostate Cancer
Biochemical recurrence of prostate cancer will be determined by PSA levels 1 year following the RALRP procedure.
Time frame: 1 year post RALRP
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prostate Artery Embolization (PAE) | Biochemical Recurrence of Prostate Cancer | 0.067 ng/mL | Standard Deviation 0.0427 |
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
Time frame: Baseline,1 year post RALRP
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prostate Artery Embolization (PAE) | Change From Baseline in Erectile Function at One Year Post RALRP | 17 Score on a scale | Standard Deviation 8.286 |
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.
Time frame: Baseline, RALRP post operative day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prostate Artery Embolization (PAE) | Change in Hematocrit | BASELINE | 39.65 percentage of red blood cells | Standard Deviation 1.99 |
| Prostate Artery Embolization (PAE) | Change in Hematocrit | POST RALRP DAY 1 | 36.92 percentage of red blood cells | Standard Deviation 1.63 |
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.
Time frame: Baseline, RALRP post operative day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prostate Artery Embolization (PAE) | Change in Hemoglobin Compared to Baseline | BASELINE | 14.3 G/DL | Standard Deviation 0.725 |
| Prostate Artery Embolization (PAE) | Change in Hemoglobin Compared to Baseline | POST RALRP DAY 1 | 11.77 G/DL | Standard Deviation 1.33 |
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.
Time frame: Baseline, 6 weeks post PAE
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prostate Artery Embolization (PAE) | Change in Prostate Volume | Baseline | 124.6 cc | Standard Deviation 30.54 |
| Prostate Artery Embolization (PAE) | Change in Prostate Volume | Week 6 | 91.55 cc | Standard Deviation 32.13 |
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.
Time frame: 6 weeks post PAE
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prostate Artery Embolization (PAE) | Change in PSA Following PAE | baseline | 9.9125 ng/mL | Standard Deviation 5.22 |
| Prostate Artery Embolization (PAE) | Change in PSA Following PAE | week 6 | 5.94 ng/mL | Standard Deviation 5.06 |
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.
Time frame: Between baseline prostate biopsy and RALRP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prostate Artery Embolization (PAE) | Histologic Changes in the Prostate After PAE | Baseline | 5.25 Units on a scale | Standard Deviation 3.5 |
| Prostate Artery Embolization (PAE) | Histologic Changes in the Prostate After PAE | Post RALP | 3.75 Units on a scale | Standard Deviation 3.77 |
Secondary
Length of Hospital Stay After RALRP
Time frame: 48 hours post procedure
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Prostate Artery Embolization (PAE) | Length of Hospital Stay After RALRP | 2 Days | Standard Deviation 0.43 |
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.
Time frame: RALRP procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prostate Artery Embolization (PAE) | Number of Participants for Whom Prostatectomy Procedure Did Not Succeed in Removing the Entire Cancer | 4 Participants |
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.
Time frame: RALRP procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prostate Artery Embolization (PAE) | Number of Patients That Required Blood Transfusion | 0 participants |
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.
Time frame: Through 1 year post RALRP
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prostate Artery Embolization (PAE) | PAE-related Adverse Events | 9 adverse events |
Secondary
RALRP Duration
Time frame: RALRP procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prostate Artery Embolization (PAE) | RALRP Duration | 2.5 hr | Standard Deviation 1.15 |
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.
Time frame: Through 1 year post RALRP
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prostate Artery Embolization (PAE) | RALRP-related Adverse Events | 4 adverse events |
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.
Time frame: An expected average of 1 week post RALRP
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prostate Artery Embolization (PAE) | Return to Continence | 463 grams | Standard Deviation 496.5 |