Prostate Artery Embolization for the Treatment of Benign Prostatic Hyperplasia

Prostatic Hyperplasia Clinical Trial

Official title:

Phase II, Single Arm Prospective Study To Evaluate Safety And Efficacy Of Prostate Artery Embolization In Patients With Lower Urinary Tract Symptoms Due To Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03179228
• Other study ID #: PAE-01
• Status: Withdrawn
• Phase: N/A
• First received: May 30, 2017
• Last updated: October 13, 2017
• Start date: October 14, 2017
• Est. completion date: June 1, 2028

Study information

• Verified date: October 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary study objective is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) at 12 months post prostatic artery embolization (PAE) with bland microspheres.

Description:

This is a phase II, single center, prospective, single arm, investigational study to evaluate the safety and efficacy of prostate artery embolization (PAE) for treatment of severe lower urinary tract symptoms (LUTS) related to BPH in patients with prostate size greater than 40 grams that either refuse surgical treatment or are considered poor candidates for traditional surgical therapy. Two hundred patients will be enrolled in the single treatment arm with follow-up for no less than 12 months.

The study will involve a screening period in which patient eligibility will be determined. Once eligibility is confirmed, patients will receive PAE with bland microspheres within 4 weeks of screening baseline imaging. After treatment, patients will return for follow-up visits at 1 month, 3 months, 6 months, and 12 months post PAE. At each of these visits, patients will complete IPSS and IIEF questionnaires, undergo a physical exam, laboratory assessment (including PSA) and perform a medication review. Repeat TRUS and uroflowmetry will be performed at the 3, 6, and 12 month post PAE follow-up visits. MRI or CT will be conducted at the 3 and 12 month visit. Cystoscopy and proctoscopy will be performed if medically indicated.

The primary endpoint will be improvement of BPH symptoms as assessed by the IPSS at 12 months post PAE. Patients will continue to be followed according to the institutional standard of care follow-up schedule after they complete the study.

Safety will be evaluated throughout the initial 12 months of the study by assessing adverse events and findings on physical examination. Concomitant medication usage will be assessed.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2028
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Patient is aged 50 years or older.

2. Patient has signed informed consent

3. Patient has experienced lower urinary tract symptoms (LUTS) for at least 6 months prior to study enrollment

4. Patient has a prostate size larger than 40g as measured by MRI or CT (if MR not possible)

5. Patient has an IPSS score greater than or equal to 13

6. Patient either:

i. Refuses surgical treatment ii. Is considered high risk for surgical treatment

7. Patient is either:

i. Refractory to medical treatment ii. Contraindicated for medical treatment

8. Patient must meet ONE of the following criteria:

• Baseline PSA = 2.5ng/mL

• Baseline PSA > 2.5 ng/mL and = 10 ng/mL AND free PSA = 25% of total PSA (no biopsy required)

• Baseline PSA > 2.5 ng/mL and = 10 ng/mL AND free PSA < 25% of total PSA AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months

• Baseline PSA >10 ng/mL AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months

9. Patient has a peak urine flow rate < 12ml/sec.

Exclusion Criteria:

1. Active prostatitis or urinary tract infection

2. History of prostate or bladder cancer, or currently being evaluated for cancer

3. Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function.

4. Urethral stricture, bladder neck contracture, other potentially confounding bladder pathology, bladder disease, or confounding urethral pathology

5. Patient has taken beta blockers, antihistamines, anticonvulsants, or antispasomodics within 1 week of study treatment AND has not been on the same drug dosage for 6 months with a stable voiding pattern.

6. Patient has taken antidepressant, anticholinergics, androgens or gonadotropin-releasing hormonal analogues within 2 months of study treatment AND has not been on the same drug dosage for at least 3 months with a stable voiding pattern.

7. Patient has taken alpha blockers within 4 weeks of study treatment AND has not been on the same drug dosage for at least 3 months with a stable voiding pattern.

8. Patient has taken 5-alpha reductase inhibitors within 3 months of study treatment AND has not been on the same drug for at least 6 months with a stable voiding pattern

9. History of open prostate surgery, radiofrequency, or microwave therapy

10. Previous open bladder or rectosigmoid colon surgery

11. Acute urinary retention requiring an indwelling catheter

12. Cystolithiasis within the past 3 months

13. Coagulation disturbances not normalized by medical treatment

14. Iodinated contrast allergy not controlled with 24-hour steroid preparation

15. History of pelvic irradiation

16. History of severe peripheral vascular disease or known major iliac arterial occlusive disease

17. Interest in future fertility

18. Significant cardiac or respiratory disease that the Investigator believes puts the patient at risk for a complication during the procedure

19. Acute urinary retention requiring an indwelling catheter

20. Life expectancy less than 6 months

21. History of rectal disease

22. Known immunosuppression either pathological or pharmacological

23. Presence of collateral vessel pathways potentially endangering normal anatomy during embolization that cannot be bypassed with the microcatheter

24. History of any illness or surgery that might confound the results of the study, by producing symptoms which may be confused with those of the disease process under consideration (e.g., Parkinson's, multiple Sclerosis), or which pose an additional risk to the patient.

Related Conditions & MeSH terms

• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Device:
• Prostate Embolization
Embolization of the prostate with acrylic polymer microspheres impregnated with porcine gelatin

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
John D Louie

Country where clinical trial is conducted

United States, 

References & Publications (2)

Carnevale FC, Iscaife A, Yoshinaga EM, Moreira AM, Antunes AA, Srougi M. Transurethral Resection of the Prostate (TURP) Versus Original and PErFecTED Prostate Artery Embolization (PAE) Due to Benign Prostatic Hyperplasia (BPH): Preliminary Results of a Single Center, Prospective, Urodynamic-Controlled Analysis. Cardiovasc Intervent Radiol. 2016 Jan;39(1):44-52. doi: 10.1007/s00270-015-1202-4. Epub 2015 Oct 27. — View Citation

Uflacker A, Haskal ZJ, Bilhim T, Patrie J, Huber T, Pisco JM. Meta-Analysis of Prostatic Artery Embolization for Benign Prostatic Hyperplasia. J Vasc Interv Radiol. 2016 Nov;27(11):1686-1697.e8. doi: 10.1016/j.jvir.2016.08.004. Epub 2016 Oct 12. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate improvement of symptoms from benign prostatic hyperplasia	The primary study objective is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) in a whole number score.	12 months
Secondary	prostate specific antigen (PSA)	Change in ng/mL from baseline	12 months
Secondary	prostate size	prostate size measured in grams, as determined by TRUS or MRI	12 months
Secondary	peak urine flow rate (Qmax)	Change from baseline in as measured in ml/sec	12 months
Secondary	post-void residual urine volume (PVR)	ml of urine in the bladder after urination	12 months
Secondary	Erectile Function Survey	as measured in 5. Change from baseline in erectile function as assessed by the International Change from baseline in erectile function as assessed by the International Index of Erectile Function (IIEF) in whole numbers	12 months