- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04807010
PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia (PROARTE)
18. marts 2021 opdateret af: Society of Interventional Radiology Foundation
This is a trial to demonstrate the superiority of prostate artery embolization (PAE) over sham procedure in men with benign prostatic hyperplasia (BPH) induced lower urinary tract symptoms (LUTS).
The trial will aim to enroll 108 patients at a 2:1 allocation over a 2 year period.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
108
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Pooja Doshi
- Telefonnummer: 580 703-460-5580
- E-mail: pdoshi@sirweb.org
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
45 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
• Men ≥45 and ≤90 years presenting with benign prostatic hyperplasia with symptoms for at least 6 months that are refractory to medical management or in whom medications are contraindicated, not tolerated, or refused.
- International Prostate Symptom Score (I-PSS) score 14 or greater.
- Quality of Life (QoL) score ≥ 3
- Peak urinary flow (Qmax) less than or equal to 12 mL/s with void volume >125mL.
- Prostate volume greater than 30 cc as determined by ultrasound, MRI, or CT.
- Personal risk <40% based on the University of Texas San Antonio prostate cancer risk calculator or having a negative prostate biopsy for cancer within the last 24 months.
- Able to provide written consent.
- Not participating in any other investigational drug or device studies.
Exclusion Criteria:
• History of biopsy-proven prostate cancer
- Renal insufficiency (glomerular filtration rates (GFR) less than 40mL/min/1.73 m2 who are not already on dialysis)
- Prior prostate surgery or intervention, including trans-urethral resection of the prostate, balloon dilation, stent implantation, laser prostatectomy, radiation, UroLift®, or hyperthermia
- Other bladder or urethral pathology requiring therapy, either in the past or currently, including neurogenic bladder, sphincteric abnormalities, bladder cancer, or other causes of bladder atonia.
- Other causes of urinary obstruction, such as strictures of urethra or ureters, not related to BPH
- Current decompensated congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression.
- Neurological disease, including multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, and previous spinal nerve surgery
- Patients with platelet count <50,000/μL or International Normalized Ratio (INR) >1.8, unless corrected for the procedure
- Active urinary tract infection. Patients must have a negative culture within 7 days of the procedure.
- Allergy to iodinated contrast agents unless pre-treated by corticosteroids.
- Acute urinary retention.
- Post void residual (PVR) > 250 mL with urodynamic evidence of atonic bladder. Patients with a PVR >250 but urodynamic testing consistent with obstruction will be allowed.
- Bladder stone within three months prior to the procedure.
- Hematuria not evaluated by Urologist for causes other than BPH.
- Previous rectal surgery (excluding hemorrhoidectomy) or history of rectal disease.
- Prior pelvic irradiation or radical pelvic surgery.
Imaging exclusion criteria:
• Internal iliac artery occlusion as determined by either CT or MRI.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Sham-komparator: Falsk
|
Prostate artery embolization reduces symptoms from benign prostatic hyperplasia by delivering embolic materials to the prostate through the prostatic arteries.
Angiogram without embolization initially.
At 6 months patients will be allowed to crossover to prostate artery embolization.
|
Aktiv komparator: Prostate artery embolization
|
Prostate artery embolization reduces symptoms from benign prostatic hyperplasia by delivering embolic materials to the prostate through the prostatic arteries.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
International Prostate Symptom Score
Tidsramme: 6 months
|
A survey accessing patient symptomology from BPH induced LUTS
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
International Prostate Symptom Score
Tidsramme: 1, 3, 6, 9, 12, 24, 36 months
|
A survey accessing patient symptomology from BPH induced LUTS
|
1, 3, 6, 9, 12, 24, 36 months
|
Quality of Life
Tidsramme: 1, 3, 6, 9, 12, 24, 36 months
|
A survey accessing quality of life impact on patients from BPH induced LUTS.
|
1, 3, 6, 9, 12, 24, 36 months
|
Maximal urinary flow rate change from baseline
Tidsramme: 6, 12, 24, and 36 months
|
Maximal flow rate of urine stream
|
6, 12, 24, and 36 months
|
Post void residual change from baseline
Tidsramme: 6, 12, 24, and 36 months
|
Post void residual measures the volume of urine remaining in the bladder after complete emptying.
|
6, 12, 24, and 36 months
|
International Index of Erectile Function questionnaire (IIEF)
Tidsramme: 1, 3, 6, 9, 12, 24, 36 months
|
A questionnaire designed to asses erectile function
|
1, 3, 6, 9, 12, 24, 36 months
|
Freedom from secondary intervention to treat BPH
Tidsramme: 1, 3, 6, 9, 12, 24, 36 months
|
Recording of other surgical/procedural treatments with each procedure being recorded as an event.
|
1, 3, 6, 9, 12, 24, 36 months
|
Ejaculatory function
Tidsramme: 3, 6, 9, 12, 24, 36 months
|
Ejaculatory function will be assessed utilizing a four item questionnaire.
|
3, 6, 9, 12, 24, 36 months
|
Urinary Continence
Tidsramme: 1, 6, and 12 months
|
Urinary Continence will be assessed using a 2 item questionnaire
|
1, 6, and 12 months
|
Number of hospital days
Tidsramme: 1 month
|
Number of hospital days following the procedure will be recorded
|
1 month
|
Recover experience
Tidsramme: 1 month
|
Recover experience will be assessed using a quality of recovery visual analog scale
|
1 month
|
Adverse events
Tidsramme: 7 days and 1, 3, 6, 9, 12, 24, 36 months
|
All procedure related adverse events will be recoreded
|
7 days and 1, 3, 6, 9, 12, 24, 36 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Shamar Young, MD, University of Minnesota
- Ledende efterforsker: Jafar Golzarian, MD, University of Minnesota
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. august 2021
Primær færdiggørelse (Forventet)
1. august 2023
Studieafslutning (Forventet)
1. august 2026
Datoer for studieregistrering
Først indsendt
11. marts 2021
Først indsendt, der opfyldte QC-kriterier
18. marts 2021
Først opslået (Faktiske)
19. marts 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. marts 2021
Sidst verificeret
1. marts 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 001 (NavyGHB)
Plan for individuelle deltagerdata (IPD)
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