Prostate CancerNCT02173522
Phase II Investigation of Prostate Artery Embolization (PAE) Before Radical Prostatectomy in Prostate Cancer Patients
A study testing Prostate artery embolization (PAE) in people with Prostate Cancer, run by Shivank Bhatia at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 79 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate artery embolization (PAE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 16 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
About this study
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
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).
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Prostate artery embolization (PAE)
- Keywords
- Prostate cancer, Prostate artery embolization, Robot-assisted laparoscopic radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate artery embolization (PAE)Device
Embolization of the arteries carrying blood to the prostate. All PAE procedures will be conducted with Embosphere Microspheres.
| Study group | Role | What they receive |
|---|---|---|
| Prostate artery embolization (PAE) | Experimental | 10 patients will receive prostate artery embolization (PAE) prior to robot-assisted laparoscopic radical prostatectomy (RALRP). Receives: Device: Prostate artery embolization (PAE) |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: RALRP procedure, up to 3 hours
Secondary outcomes (14)
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.
Measured: Baseline, RALRP post operative day
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.
Measured: 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.
Measured: 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.
Measured: RALRP procedure
RALRP Duration
Measured: RALRP procedure
Length of Hospital Stay After RALRP
Measured: 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.
Measured: RALRP procedure
Biochemical Recurrence of Prostate Cancer
Biochemical recurrence of prostate cancer will be determined by PSA levels 1 year following the RALRP procedure.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Between baseline prostate biopsy and RALRP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJul 2014
- Primary completion16 Jun 2017
- Study completion16 Jun 2017
Why it stopped: Recruitment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shivank Bhatia
- Sponsor type
- University, hospital or other
- Collaborators
- Merit Medical Systems, Inc., Society of Interventional Radiology Foundation
- Responsible party
- Sponsor-investigator, Shivank Bhatia, University of Miami
- Investigators
- Shivank Bhatia, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173522
- Sponsor's protocol ID
- 20131034
- Status last verified
- Jun 2019
- First submitted
- 22 May 2014
- Last updated
- 25 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02173522
- Acronym / sponsor ID
- 20131034
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Prostate artery embolization, Robot-assisted laparoscopic radical prostatectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulty
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Shivank BhatiaUniversity, hospital or other
- Collaborators
- Merit Medical Systems, Inc., Society of Interventional Radiology Foundation
- Study start
- Jul 2014
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Posted 25 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate artery embolization (PAE) | Experimental | Device: Prostate artery embolization (PAE)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. |
Who may qualify
- Ages
- 45 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate artery embolization (PAE)Embolization of the arteries carrying blood to the prostate. All PAE procedures will be conducted with Embosphere Microspheres. | Device | Prostate artery embolization (PAE) |
Primary outcome
Estimated Blood Loss During Robot-assisted Laparoscopic Radical Prostatectomy (RALRP)
Time frame: RALRP procedure, up to 3 hours
Blood loss during the robotic prostatectomy will be estimated by the surgeon performing the procedure.
14 secondary outcomes
Change in Hemoglobin Compared to Baseline
Time frame: Baseline, RALRP post operative day
Change in Hematocrit
Time frame: Baseline, RALRP post operative day 1
Change in Prostate Volume
Time frame: Baseline, 6 weeks post PAE
Number of Patients That Required Blood Transfusion
Time frame: RALRP procedure
RALRP Duration
Time frame: RALRP procedure
Length of Hospital Stay After RALRP
Time frame: 48 hours post procedure
Number of Participants for Whom Prostatectomy Procedure Did Not Succeed in Removing the Entire Cancer
Time frame: RALRP procedure
Biochemical Recurrence of Prostate Cancer
Time frame: 1 year post RALRP
Return to Continence
Time frame: An expected average of 1 week post RALRP
RALRP-related Adverse Events
Time frame: Through 1 year post RALRP
PAE-related Adverse Events
Time frame: Through 1 year post RALRP
Change From Baseline in Erectile Function at One Year Post RALRP
Time frame: Baseline,1 year post RALRP
Change in PSA Following PAE
Time frame: 6 weeks post PAE
Histologic Changes in the Prostate After PAE
Time frame: Between baseline prostate biopsy and RALRP
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shivank Bhatia, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate artery embolization (PAE) in people with Prostate Cancer, run by Shivank Bhatia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated Blood Loss During Robot-assisted Laparoscopic Radical Prostatectomy (RALRP) (time frame: RALRP procedure, up to 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.