Phase II Investigation of Prostate Artery Embolization (PAE) Before Radical Prostatectomy in Prostate Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02173522|
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : June 21, 2017
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Device: Prostate artery embolization (PAE)|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||July 2014|
|Primary Completion Date :||June 16, 2017|
|Study Completion Date :||June 16, 2017|
Experimental: Prostate artery embolization (PAE)
10 patients will receive prostate artery embolization (PAE) prior to robot-assisted laparoscopic radical prostatectomy (RALRP).
Device: Prostate artery embolization (PAE)
Embolization of the arteries carrying blood to the prostate. All PAE procedures will be conducted with Embosphere Microspheres.
No Intervention: 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.
- Estimated blood loss during robot-assisted laparoscopic radical prostatectomy (RALRP) [ Time Frame: RALRP procedure ]Blood loss during the robotic prostatectomy will be estimated by the surgeon performing the procedure.
- Change in hemoglobin compared to baseline [ Time Frame: RALRP post operative day 1 ]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 [ Time Frame: 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 [ Time Frame: 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.
- Blood transfusion requirements [ Time Frame: 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 [ Time Frame: RALRP procedure ]
- Length of hospital stay after RALRP [ Time Frame: An expected average of 24-48 hours ]
- Presence or absence of complete surgical margin [ Time Frame: RALRP procedure ]Histopathology examination post RALRP will be used to determine if the prostatectomy procedure succeeded in removing the entire cancer.
- Biochemical recurrence of prostate cancer [ Time Frame: 1 year post RALRP ]Biochemical recurrence of prostate cancer will be determined by PSA levels 1 year following the RALRP procedure.
- Return to continence [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Erectile function compared to baseline [ Time Frame: 1 year post RALRP ]The International Index of Erectile Function will be used to assess changes in erectile function through 1 year of follow-up post RALRP.
- Change in PSA following PAE [ Time Frame: 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 [ Time Frame: Between baseline prostate biopsy and RALRP ]Among patients who undergo PAE, histology examination following RALRP will be compared to the histology of the pre-PAE prostate biopsy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02173522
|United States, Florida|
|Sylvester Comprehensive Cancer Center|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Shivank Bhatia, MD||University of Miami|