Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostatic Artery Embolization (PAE) | Experimental | Participants who receive PAE with Merit Medical Embospheres. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Merit Medical Embospheres | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | At screening, Day of PAE, and 6 weeks & 12 weeks after PAE |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 12 weeks |
| Change in American Urologic Association Score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
male
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nainesh S Parikh, MD, MBA | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
Not provided
| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Radiation Therapy | Radiation | Patients will undergo standard of care definitive radiation therapy. |
|
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".
| At 18 weeks |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |