None listed
Conditions
Brief summary
Prostate artery embolisation (PAE) is a minimally invasive technique that has proven effective in decreasing lower urinary tract symptoms (LUTS) in men with medically refractive benign prostatic hyperplasia (BPH). BPH, or an enlarging prostate, affects more than 50% of males older than 60 years. LUTS include multiple night-time urination, urgency, hesitancy initiating urination, weak or interrupted urinary stream and post-urination dribble. The primary goals of BPH therapy are to decrease LUTS, improve quality of life (QoL) and prevent disease progression. For men with mild-to-moderate symptoms, sequential step-up therapy starting with watchful waiting and escalating to single or multiple medical therapies and, in some cases surgery, constitutes common clinical practice. A common combined medical therapy is Duodart, a fixed-dose combination of 0.5 mg Dutasteride and 0.4 mg Tamsulosin, that is usually prescribed for men with more severe prostate enlargement. The benefits of combined therapy can be explained by the synergistic mechanisms of action of the component drugs. Tamsulosin, an a-blocker, relaxes the smooth muscle tissue in the prostate and bladder neck, allowing urine to flow more freely. Treatment with Tamsulosin provides improvement of LUTS but has no effect on prostate growth. Dutasteride, a 5-alpha reductase inhibitor, blocks the production of dihydrotestosterone, the metabolic driver of prostate growth. Thus Dutasteride treatment reduces prostate size and impedes disease progression related to prostatic overgrowth. Adverse side effects associated with these medication include retrograde ejaculation, urinary incontinence and impotence. Overall, medications are generally ineffective for long-term control of LUTS, and medical therapies are often abandoned because of poor tolerance and inefficacy. PAE is emerging as a viable alternative to medication and invasive surgery for patients with LUTS. PAE has already shown promise as a short to medium-term treatment in patients who are not willing, or not able to undergo surgery. Medium-term follow-up in patients who have undergone PAE demonstrates that: • Improved symptoms and increased quality of life persist for at least 5 years in a majority of patients, • PAE is more efficacious than medical therapy alone, • PAE causes fewer side-effects than surgical resection, • PAE can be repeated if required, and does not preclude future surgical options. To date, a direct comparison between PAE and medical therapy in a randomised controlled trial has not been performed. The study proposed here will extend knowledge in this area by investigating whether PAE is a suitable intervention in treatment-naive men who would otherwise be prescribed medications as a first-line treatment.
Interventions
There are two treatment groups in this trial; prostate artery embolization (new intervention) and medical therapy (Duodart, current standard treatment).
Prostate artery embolisation procedures are performed by interventional radiologists experienced in prostate artery embolisation. The procedure takes approximately 120 minutes. Procedures will be performed with a right femoral or left brachial artery approach, using 4- or 5- French sheaths. 5-Fr 125 cm Impulse (Merit Medical, Utah, USA) and 4-
There are two treatment groups in this trial; prostate artery embolization (new intervention) and medical therapy (Duodart, current standard treatment). Prostate artery embolisation procedures are performed by interventional radiologists experienced in prostate artery embolisation. The procedure takes approximately 120 minutes. Procedures will be performed with a right femoral or left brachial artery approach, using 4- or 5- French sheaths. 5-Fr 125 cm Impulse (Merit Medical, Utah, USA) and 4-Fr 120 cm Cobra Glidecath (Terumo, New Jersey, USA) catheters are combined with 150 cm standard Glidewires (Terumo, New Jersey, USA) to access the internal iliac arteries. Microcatheters 2.0Fr Progreat (Terumo, New Jersey, USA) or 1.7Fr SL-10 (Stryker, Michigan, USA) are used to selectively catheterise the prostate arteries over microwires, either 0.016” Radifocus Guidewire GT (Terumo, New Jersey, USA) or 0.014” Synchro Standard (Stryker, Michigan, USA). Following selective catheterisation of the prostate arteries and positioning of the microcatheter tip within the distal prostate artery, an on-table Dyna CT scan using hand-injected 1-2 ml contrast (Ultravist 300, Bayer, Leverkusen, Germany) in a 3 ml Medallion syringe (Merit Medical, Utah, USA) is performed and reviewed in three planes to assess for non-prostatic enhancement. Once the operators are confident that no off-target enhancement is evident, a single unit syringe of 250 micron Embozene (Celenova Biosciences, Texas, USA) is prepared by diluting the Embozene particles with full contrast to 1/16 (6.25%) of the original concentration. Embolisation is then performed by slowly injecting the diluted particles until complete stasis of the prostate artery has been achieved. Medical therapy with Duodart, a fixed-dose combination of 0.5 mg Dutasteride (a 5-alpha reductase inhibitor) and 0.4 mg Tamsulosin (a-blocker) will be taken as a once daily oral tablet. Patients in each group will be followed-up at six months post-treatment commencement and any patient who has not satisfactorily responsed to their treatment will be offered the other treatment option. Response to treatment will be assessed based on a range of parameters, these include; severity of symptoms (IPSS questionnaire with quality of life question); change in prostate volume (measured by ultrasound); change in bladder function (ultrasound and urodynamic testing); treatment side effects (questionnaire designed specifically for this study); and the patient's satisfaction with their response to treatment (questionnaire designed specifically for this study). Patient eligibility for cross over will be assessed on a case-by-case basis and permitted if; a) the patient is unsatisfied with their response to treatment and b) if the treating specialists (urologist and interventional radiologist) agree an improved response is likely with treatment crossover.
Sponsors
Wesley Medical Imaging
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
BPH with prostate volume > 50cc Moderate-severe lower urinary tract symptoms (IPSS >8) Peak urinary flow <12ml/sec Obstructive urodynamics Treatment-naive, i.e. no previous medical therapy for BPH.
Exclusion criteria
Prostate malignancy Neurogenic bladder Renal failure eGFR <35ml/min Severe peripheral vascular disease Urethral or bladder pathology History of medical therapy for BPH.
Outcome results
None listed