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Phase II Investigation of Prostate Artery Embolization (PAE) Before Radical Prostatectomy in Prostate Cancer Patients

Primary Purpose

Prostate Cancer

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Prostate artery embolization (PAE)

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Prostate artery embolization, Robot-assisted laparoscopic radical prostatectomy

Eligibility Criteria

45 Years - 79 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Sylvester Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prostate artery embolization (PAE)

Control

Arm Description

10 patients will receive prostate artery embolization (PAE) prior to robot-assisted laparoscopic radical prostatectomy (RALRP).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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 Duration

Length of Hospital Stay After RALRP

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.

Biochemical Recurrence of Prostate Cancer

Biochemical recurrence of prostate cancer will be determined by PSA levels 1 year following the RALRP procedure.

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.

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.

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.

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

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.

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.

Full Information

NCT ID

NCT02173522

First Posted

May 22, 2014

Last Updated

June 1, 2019

Sponsor

Shivank Bhatia

Collaborators

Merit Medical Systems, Inc., Society of Interventional Radiology Foundation

1. Study Identification

Unique Protocol Identification Number

NCT02173522

Brief Title

Phase II Investigation of Prostate Artery Embolization (PAE) Before Radical Prostatectomy in Prostate Cancer Patients

Official Title

Phase II Open Label Investigation of the Safety and Efficacy of Pre-Operative Prostate Artery Embolization (PAE) Before Radical Prostatectomy in Prostate Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Terminated

Why Stopped

Recruitment difficulty

Study Start Date

July 2014 (undefined)

Primary Completion Date

June 16, 2017 (Actual)

Study Completion Date

June 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Shivank Bhatia

Collaborators

Merit Medical Systems, Inc., Society of Interventional Radiology Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostate cancer, Prostate artery embolization, Robot-assisted laparoscopic radical prostatectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prostate artery embolization (PAE)

Arm Type

Experimental

Arm Description

10 patients will receive prostate artery embolization (PAE) prior to robot-assisted laparoscopic radical prostatectomy (RALRP).

Arm Title

Control

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

Prostate artery embolization (PAE)

Intervention Description

Embolization of the arteries carrying blood to the prostate. All PAE procedures will be conducted with Embosphere Microspheres.

Primary Outcome Measure Information:

Title

Estimated Blood Loss During Robot-assisted Laparoscopic Radical Prostatectomy (RALRP)

Description

Blood loss during the robotic prostatectomy will be estimated by the surgeon performing the procedure.

Time Frame

RALRP procedure, up to 3 hours

Secondary Outcome Measure Information:

Title

Change in Hemoglobin Compared to Baseline

Description

Time Frame

Baseline, RALRP post operative day

Title

Change in Hematocrit

Description

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

Title

Change in Prostate Volume

Description

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

Title

Number of Patients That Required Blood Transfusion

Description

Time Frame

RALRP procedure

Title

RALRP Duration

Time Frame

RALRP procedure

Title

Length of Hospital Stay After RALRP

Time Frame

48 hours post procedure

Title

Number of Participants for Whom Prostatectomy Procedure Did Not Succeed in Removing the Entire Cancer

Description

Histopathology examination post RALRP will be used to determine if the prostatectomy procedure succeeded in removing the entire cancer.

Time Frame

RALRP procedure

Title

Biochemical Recurrence of Prostate Cancer

Description

Biochemical recurrence of prostate cancer will be determined by PSA levels 1 year following the RALRP procedure.

Time Frame

1 year post RALRP

Title

Return to Continence

Description

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

Title

RALRP-related Adverse Events

Description

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

Title

PAE-related Adverse Events

Description

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

Title

Change From Baseline in Erectile Function at One Year Post RALRP

Description

Time Frame

Baseline,1 year post RALRP

Title

Change in PSA Following PAE

Description

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

Title

Histologic Changes in the Prostate After PAE

Description

Time Frame

Between baseline prostate biopsy and RALRP

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shivank Bhatia, MD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sylvester Comprehensive Cancer Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Phase II Investigation of Prostate Artery Embolization (PAE) Before Radical Prostatectomy in Prostate Cancer Patients

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