The purpose of this research study is to evaluate prostate artery embolization (PAE) compared to Holmium laser enucleation of prostate (HoLEP) in improving a patient's overall prostate related symptoms.
Source : Importé depuis le centre
RECRUTEMENT
Profil des participants
Limites d'âge
minimum : 50 ans
Sexe(s) des participants
MALE
Source : Importé depuis le centre
Condition médicale (spécialité visée)
Domaine de recherche
Donnée non disponible
Critères de sélection
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
Embosphere Microspheres group
Participants in this group who are undergoing standard of care (SOC) prostate artery embolization (PAE) for treatment of their symptomatic benign prostatic hyperplasia (BPH) will receive Embosphere Microspheres during scheduled SOC PAE surgery.
Donnée non disponible
Inconnu
HoLEP Group
Participants in this group who are undergoing SOC PAE for treatment of their symptomatic benign prostatic hyperplasia (BPH) will receive SOC Holmium laser enucleation of prostate (HoLEP).
Donnée non disponible
Inconnu
Embosphere Microspheres group
État du recrutement
unknown
Participants in this group who are undergoing standard of care (SOC) prostate artery embolization (PAE) for treatment of their symptomatic benign prostatic hyperplasia (BPH) will receive Embosphere Microspheres during scheduled SOC PAE surgery.
HoLEP Group
État du recrutement
unknown
Participants in this group who are undergoing SOC PAE for treatment of their symptomatic benign prostatic hyperplasia (BPH) will receive SOC Holmium laser enucleation of prostate (HoLEP).
Données à jour depuis :
3 mai 2025
SITES ET CONTACTS
Centre principal
university of miami sylvester cancer center
MIAMI, FLORIDA, UNITED STATES
Recrutement local
—
FERMÉ
Dernière modification :
3 mai 2025
Données à jour depuis :
12 juil.
Origine des données :
clinicaltrials.gov
1. Patient is age 50 or older.
2. Patient has signed informed consent and agrees to attend all follow-up study visits.
3. Patient has had LUTS secondary to BPH or any complications secondary to BPH and qualifying for active intervention.
4. Patient has a baseline IPSS Score \> 13 at baseline.
5. Patient has a prostate size of at least 80 grams and not more than 250 grams, measured by magnetic resonance imaging (MRI) or transrectal ultrasonography (TRUS).
6. Patient has BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated, or refused.
7. Patient must be a candidate for HoLEP or PAE.
Exclusion Criteria:
1. Subject has untreated active infection (e.g., active urinary tract infection or prostatitis)
2. Subject has a diagnosis or received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis).
3. Patients with indwelling urinary catheters or those performing self-catheterization.
4. Biopsy proven prostate or bladder cancer.
- Patient with elevated PSA will be counselled by urologist and a shared decision will be made with the patient after discussion about pros and cons of prostate biopsy.
5. Patients with neurogenic bladder disorder.
6. Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition.
7. Patients with prior history transurethral resection of the prostate (TURP), Green Light laser treatment, or other prostate surgical treatments within past year(12 months).
8. Any known condition that limits catheter-based intervention or is a contraindication to embolization, such as intolerance to a vessel occlusion procedure or severe atherosclerosis.
9. Cardiac condition including congestive heart failure or arrhythmia, uncontrolled diabetes mellitus, significant respiratory disease or known immunosuppression which required hospitalization within the previous 6 months.
10. Acute myocardial infarction, open heart surgery, or cardiac arrest within 180 days prior to the date of informed consent.
11. Patient is interested in future fertility and wish to preserve ejaculation will be excluded from HoLEP arm
12. History of coagulation cascade disorders (which are not normalized by medical treatment before the procedure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperative or postoperative bleeding.
13. History of major allergic reaction to iodinated contrast agents will be excluded from PAE arm.
14. History of hypersensitivity to gelatin products will be excluded from PAE arm.
15. Subject has a life expectancy of less than 2 yrs.
16. Post void residual more than 500 ml at baseline.
17. Participation in any other BPH trials during the time of study.
Source : Importé depuis le centre
Cohortes
Thérapie ou Intervention proposée
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
Embosphere Microspheres group
Participants in this group who are undergoing standard of care (SOC) prostate artery embolization (PAE) for treatment of their symptomatic benign prostatic hyperplasia (BPH) will receive Embosphere Microspheres during scheduled SOC PAE surgery.
Donnée non disponible
Inconnu
HoLEP Group
Participants in this group who are undergoing SOC PAE for treatment of their symptomatic benign prostatic hyperplasia (BPH) will receive SOC Holmium laser enucleation of prostate (HoLEP).
Donnée non disponible
Inconnu
Embosphere Microspheres group
État du recrutement
unknown
Participants in this group who are undergoing standard of care (SOC) prostate artery embolization (PAE) for treatment of their symptomatic benign prostatic hyperplasia (BPH) will receive Embosphere Microspheres during scheduled SOC PAE surgery.
HoLEP Group
État du recrutement
unknown
Participants in this group who are undergoing SOC PAE for treatment of their symptomatic benign prostatic hyperplasia (BPH) will receive SOC Holmium laser enucleation of prostate (HoLEP).
Données à jour depuis :
3 mai 2025
Description de l'étude
Description de l'étude
Résumé de l'étude
The purpose of this research study is to evaluate prostate artery embolization (PAE) compared to Holmium laser enucleation of prostate (HoLEP) in improving a patient's overall prostate related symptoms.
Source : Importé depuis le centre
Centres participants
Sites
Centres participants
1
centres
UNIVERSITY OF MIAMI SYLVESTER CANCER CENTER
Miami
FLORIDA, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
Source d'information
Dernière modification :
3 mai 2025
Données à jour depuis :
12 juil.
Origine des données :
clinicaltrials.gov
