Prostate CancerNCT05415696
Prostatic Artery Embolization for the Treatment of Lower Urinary Tract Symptoms in Prostate Cancer Patients Undergoing Radiation Therapy
A study testing Prostatic artery embolization in people with Prostate Cancer, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to learn if the prostatic artery embolization procedure can reduce urinary tract symptoms in patients with enlarged prostates and prostate cancer. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostatic artery embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years and ≤ 90 years old
- Prostate volume ≥ 40 mL and ≤ 300 mL
- Biopsy proven prostate cancer undergoing radiation therapy
- Diagnosis of moderate to severe lower urinary tract symptoms (LUTS) defined as at least one of the following:
- IPSS ≥ 12 or dependent on urinary catheterization, or
- IPSS Quality of Life (QoL) assessment ≥ 3, and
- Qmax ≤ 12 mL/sec
- Ability to understand and willingness to sign the written consent
Who cannot join
- Neurogenic bladder disorder due to multiple sclerosis, Parkinson's disease, spinal cord injury, diabetes, etc., as demonstrated on urodynamic testing.
- Detrusor muscle failure, urethral stenosis, or urinary obstruction due to causes other than prostatic obstruction, as demonstrated on urodynamic testing
- Bladder diverticula greater than 5 cm or bladder stones greater than 2 cm
- Other active urogenital cancer
- Baseline serum creatinine greater than 2 mg/dL
- Evidence of tortuous or atherosclerotic blood vessels
- Coagulation disturbances not normalized by medical treatment
- Allergy to iodinated contrast agents not responsive to steroid premedication regimen
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Cancer Center
San Francisco, California, 94305
About this study
Official title: Prostatic Artery Embolization (PAE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Prostate Cancer Patients Undergoing Radiation Therapy
The purpose of this study is to learn if the prostatic artery embolization procedure can reduce urinary tract symptoms in patients with enlarged prostates and prostate cancer.
Read the detailed description
PRIMARY OBJECTIVE
- To evaluate the symptomatic improvement in lower urinary tract symptoms after prostatic artery embolization (PAE)
SECONDARY OBJECTIVES
- To evaluate objective measures of improved urinary obstruction after PAE: urine flow rate, prostate volume, and post-void residual
- To measure effects of PAE on prostate specific antigen (PSA).
- To evaluate if PAE reduces the prostate volume and simplifies radiation therapy
- To evaluate the safety of PAE performed in this patient population
- Conditions
- Prostate Cancer
- Being tested
- Prostatic artery embolization
- Keywords
- Prostatic artery embolization, Lower urinary tract symptoms
- Medical subject headings
- Prostatic Neoplasms, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostatic artery embolizationProcedure or surgery
Patients will undergo PAE with 100-300 µm or 300-500 µm Embospheres following standard PAE technique performed by Interventional Radiology at Stanford University
| Study group | Role | What they receive |
|---|---|---|
| Prostatic artery embolization (PAE) | Other | Study participants will be treated with a single PAE procedure performed with Embosphere microspheres. Receives: Procedure: Prostatic artery embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in symptom score using the International Prostate Symptom Scale (IPSS)
Patients will be classified into one of 3 symptom severity categories based on their total IPSS score as follows:
Mildly symptomatic: 0-7 Moderately symptomatic: 8-19 Severely symptomatic: 20-35
Measured: 2 months
Secondary outcomes (5)
Mean change from baseline in maximal urinary flow measured
Measured: at baseline, 2 months, and 12 months after intervention
Mean change from baseline in post-void residual measured
Measured: at baseline, 2 months, and 12 months after intervention
Mean change from baseline in prostate volume measure
Measured: at baseline, 2 months, and 12 months after intervention
Mean change from baseline in international prostate symptom scale to measure long term subjective outcomes measured
Patients will be classified into one of 3 symptom severity categories based on their total IPSS score as follows:
Mildly symptomatic: 0-7 Moderately symptomatic: 8-19 Severely symptomatic: 20-35
Measured: at baseline, 2 months, and 12 months after intervention
Mean change from baseline prostate specific antigen measure
Measured: at baseline, 2 months, and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start19 Sep 2023
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Why it stopped: Enrolling to this clinical trial was too difficult
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Picel, Stanford University
- Investigators
- Andrew Picel, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415696
- Sponsor's protocol ID
- IRB-64391
- Other IDs
- PROS0108
- Status last verified
- Aug 2024
- First submitted
- 8 Jun 2022
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostatic Artery Embolization (PAE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Prostate Cancer Patients Undergoing Radiation Therapy
- ClinicalTrials.gov ID
- NCT05415696
- Acronym / sponsor ID
- IRB-64391
- Conditions
- Prostate Cancer
- Keywords
- Prostatic artery embolization, Lower urinary tract symptoms
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrolling to this clinical trial was too difficult
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
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 learn if the prostatic artery embolization procedure can reduce urinary tract symptoms in patients with enlarged prostates and prostate cancer.
Detailed description
PRIMARY OBJECTIVE
- To evaluate the symptomatic improvement in lower urinary tract symptoms after prostatic artery embolization (PAE)
SECONDARY OBJECTIVES
- To evaluate objective measures of improved urinary obstruction after PAE: urine flow rate, prostate volume, and post-void residual
- To measure effects of PAE on prostate specific antigen (PSA).
- To evaluate if PAE reduces the prostate volume and simplifies radiation therapy
- To evaluate the safety of PAE performed in this patient population
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostatic artery embolization (PAE) | Other | Procedure: Prostatic artery embolizationStudy participants will be treated with a single PAE procedure performed with Embosphere microspheres. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 40 years and ≤ 90 years old
- Prostate volume ≥ 40 mL and ≤ 300 mL
- Biopsy proven prostate cancer undergoing radiation therapy
- Diagnosis of moderate to severe lower urinary tract symptoms (LUTS) defined as at least one of the following:
- Ability to understand and willingness to sign the written consent
Key exclusion criteria (8 listed)
- Neurogenic bladder disorder due to multiple sclerosis, Parkinson's disease, spinal cord injury, diabetes, etc., as demonstrated on urodynamic testing.
- Detrusor muscle failure, urethral stenosis, or urinary obstruction due to causes other than prostatic obstruction, as demonstrated on urodynamic testing
- Bladder diverticula greater than 5 cm or bladder stones greater than 2 cm
- Other active urogenital cancer
- Baseline serum creatinine greater than 2 mg/dL
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 |
|---|---|---|
| Prostatic artery embolizationPatients will undergo PAE with 100-300 µm or 300-500 µm Embospheres following standard PAE technique performed by Interventional Radiology at Stanford University | Procedure or surgery | Prostatic artery embolization (PAE) |
Primary outcome
Mean change from baseline in symptom score using the International Prostate Symptom Scale (IPSS)
Time frame: 2 months
Patients will be classified into one of 3 symptom severity categories based on their total IPSS score as follows: Mildly symptomatic: 0-7 Moderately symptomatic: 8-19 Severely symptomatic: 20-35
5 secondary outcomes
Mean change from baseline in maximal urinary flow measured
Time frame: at baseline, 2 months, and 12 months after intervention
Mean change from baseline in post-void residual measured
Time frame: at baseline, 2 months, and 12 months after intervention
Mean change from baseline in prostate volume measure
Time frame: at baseline, 2 months, and 12 months after intervention
Mean change from baseline in international prostate symptom scale to measure long term subjective outcomes measured
Time frame: at baseline, 2 months, and 12 months after intervention
Mean change from baseline prostate specific antigen measure
Time frame: at baseline, 2 months, and 12 months after intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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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.
Andrew Picel, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostatic artery embolization in people with Prostate Cancer, run by Stanford University 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 8 inclusion and 8 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: withdrawn, as of the sponsor's last update on 9 Aug 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mean change from baseline in symptom score using the International Prostate Symptom Scale (IPSS) (time frame: 2 months). 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 9 Aug 2024.