Prostate CarcinomaPhase 2NCT04879940
Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization
A Phase 2 study testing Merit Medical Embospheres and Radiation Therapy in people with Prostate Carcinoma and Benign Prostatic Hyperplasia, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
This is a Phase II prospective clinical trial in which patients with prostate carcinoma and obstructive lower urinary tract symptoms electing for radiation therapy will undergo Prostatic Artery Embolization (PAE) prior to treatment. PAE will be administered by Interventional Radiology. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Carcinoma, Benign Prostatic Hyperplasia
- What is being tested?
- Merit Medical Embospheres and Radiation Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2022to Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed prostate adenocarcinoma in the very low or low or favorable intermediate risk risk stratification groups (i.e. Gleason Grade groups 1 and 2) who are eligible for and who select XRT as their cancer management method.
- Ability to receive prostatic artery embolization within 6-12 weeks of definitive radiation therapy.
- Ability to understand and the willingness to sign a written informed consent document
- Prostate larger than 60 grams but less than 150 grams, as assessed by imaging scans
- American Urologic Association (AUA) or International Prostate Symptom Score (IPSS) Score ≥ 15
- Normal organ and marrow function as defined in protocol
Who cannot join
- Patients with Gleason Grade Group 1 or 2 PCa who select active surveillance as their cancer management method.
- Receiving androgen deprivation therapy (ADT)
- Patients with unfavorable intermediate (Gleason Grade Group 3) or high risk localized PCa (Gleason Grade Groups 4 and 5)
- Receiving any investigational agents for the explicit purpose of prostatic size reduction
- Inability to receive prostatic artery embolization (PAE) within 6-12 weeks of definitive radiation therapy
- Active urinary tract infection (UTI)
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- History of severe allergic reaction to intravenous contrast media (iodinated and gadolinium- based) or any agents used during the PAE; patient cannot be medicated against allergic reaction prior to PAE.
- Active cystolithiasis or prostatitis
- Inability to have multi-parametric magnetic resonance imaging (mpMRI)
- Prior transurethral resection of the prostate (TURP) within 2 years
- Prostate size greater than or equal to150 grams
- Vulnerable subjects (e.g., inmates and developmentally delayed adults) who are subjects for whom the study may be unsafe or whose rights may be violated with enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization in Patients With Localized Prostate Carcinoma and Obstructive Lower Urinary Tract Symptoms
This is a Phase II prospective clinical trial in which patients with prostate carcinoma and obstructive lower urinary tract symptoms electing for radiation therapy will undergo Prostatic Artery Embolization (PAE) prior to treatment. PAE will be administered by Interventional Radiology. Patients will be seen for follow-up at 6 weeks and 12 weeks following PAE after which they will start definitive radiotherapy. After completion of radiotherapy the patient will be seen at 12 weeks
- Conditions
- Prostate Carcinoma, Benign Prostatic Hyperplasia
- Being tested
- Merit Medical Embospheres, Radiation Therapy
- Medical subject headings
- Prostatic Neoplasms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Merit Medical EmbospheresDevice
Prostatic Artery Embolization will performed as an outpatient procedure in Interventional Radiology. Bilateral selective pelvic angiograms will be performed to localize the prostatic arteries. Cone-beam or 3D computed tomography (CT) will be performed prior to embolization, if technically feasible and necessary. Embolization will be performed using Merit Medical Embospheres.
Radiation TherapyRadiation
Patients will undergo standard of care definitive radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Prostatic Artery Embolization (PAE) | Experimental | Participants who receive PAE with Merit Medical Embospheres. Receives: Device: Merit Medical Embospheres; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Prostate Symptom Score
Participants will take quality of life questionnaires including the International Prostate Symptom Score (IPSS)questionnaire to determine changes in prostate symptoms. Questionnaire will be taken at screening, Day 0- day of prostatic artery embolization (PAE), and at 6 weeks and 12 weeks after PAE. The IPSS asks the patient to rate urinary symptoms on a scale of 0-5, 0 indicating the participant has not had a symptom at all, and 5 indicating the symptom "almost always".
Measured: At screening, Day of PAE, and 6 weeks & 12 weeks after PAE
Secondary outcomes (2)
Prostate Volume Reduction after PAE
Prostate volume will be determined by MRI prior to PAE and at 12 weeks post PAE to determine changes in volume.
Measured: At 12 weeks
Change in American Urologic Association Score
Participants will take quality of life questionnaires including the American Urologic Association (AUA) test to assess genitourinary toxicity after PAE and radiation therapy. The AUA questionnaire asks the patient to rate urinary symptoms on a scale of 0-5, 0 indicating indicating the participant has not had a symptom at all, and 5 indicating the symptom "almost always".
Measured: At 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start23 Feb 2022
- Primary completion16 Jun 2026
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nainesh S Parikh, MD, MBA, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879940
- Sponsor's protocol ID
- MCC-20832
- Status last verified
- Jul 2026
- First submitted
- 5 May 2021
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization in Patients With Localized Prostate Carcinoma and Obstructive Lower Urinary Tract Symptoms
- ClinicalTrials.gov ID
- NCT04879940
- Acronym / sponsor ID
- MCC-20832
- Conditions
- Prostate Carcinoma, Benign Prostatic Hyperplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 16 Jun 2026 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 10 May 2021 (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.
This is a Phase II prospective clinical trial in which patients with prostate carcinoma and obstructive lower urinary tract symptoms electing for radiation therapy will undergo Prostatic Artery Embolization (PAE) prior to treatment. PAE will be administered by Interventional Radiology. Patients will be seen for follow-up at 6 weeks and 12 weeks following PAE after which they will start definitive radiotherapy. After completion of radiotherapy the patient will be seen at 12 weeks
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) | Experimental | Device: Merit Medical Embospheres, Radiation: Radiation TherapyParticipants who receive PAE with Merit Medical Embospheres. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed prostate adenocarcinoma in the very low or low or favorable intermediate risk risk stratification groups (i.e. Gleason Grade groups 1 and 2) who are eligible for and who select XRT as their cancer management method.
- Ability to receive prostatic artery embolization within 6-12 weeks of definitive radiation therapy.
- Ability to understand and the willingness to sign a written informed consent document
- Prostate larger than 60 grams but less than 150 grams, as assessed by imaging scans
- American Urologic Association (AUA) or International Prostate Symptom Score (IPSS) Score ≥ 15
Key exclusion criteria (12 listed)
- Patients with Gleason Grade Group 1 or 2 PCa who select active surveillance as their cancer management method.
- Receiving androgen deprivation therapy (ADT)
- Patients with unfavorable intermediate (Gleason Grade Group 3) or high risk localized PCa (Gleason Grade Groups 4 and 5)
- Receiving any investigational agents for the explicit purpose of prostatic size reduction
- Inability to receive prostatic artery embolization (PAE) within 6-12 weeks of definitive radiation therapy
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 |
|---|---|---|
| Merit Medical EmbospheresProstatic Artery Embolization will performed as an outpatient procedure in Interventional Radiology. Bilateral selective pelvic angiograms will be performed to localize the prostatic arteries. Cone-beam or 3D computed tomography (CT) will be performed prior to embolization, if technically feasible and necessary. Embolization will be performed using Merit Medical Embospheres. | Device | Prostatic Artery Embolization (PAE) |
| Radiation TherapyPatients will undergo standard of care definitive radiation therapy. | Radiation | Prostatic Artery Embolization (PAE) |
Primary outcome
Change in International Prostate Symptom Score
Time frame: At screening, Day of PAE, and 6 weeks & 12 weeks after PAE
Participants will take quality of life questionnaires including the International Prostate Symptom Score (IPSS)questionnaire to determine changes in prostate symptoms. Questionnaire will be taken at screening, Day 0- day of prostatic artery embolization (PAE), and at 6 weeks and 12 weeks after PAE. The IPSS asks the patient to rate urinary symptoms on a scale of 0-5, 0 indicating the participant has not had a symptom at all, and 5 indicating the symptom "almost always".
2 secondary outcomes
Prostate Volume Reduction after PAE
Time frame: At 12 weeks
Change in American Urologic Association Score
Time frame: At 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Nainesh S Parikh, MD, MBA principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Merit Medical Embospheres and Radiation Therapy in people with Prostate Carcinoma and Benign Prostatic Hyperplasia, run by H. Lee Moffitt Cancer Center and Research Institute 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 6 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in International Prostate Symptom Score (time frame: At screening, Day of PAE, and 6 weeks & 12 weeks after PAE). 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 30 Jul 2026.