UroLift System With SAbR for Prostate Cancer and BPH

The University of Texas System (UT)

Status and phase

Enrolling

Phase 1

Conditions

Prostate Cancer

Treatments

Device: Urolift

Radiation: SABR

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05311527

STU 2022-0261

Details and patient eligibility

About

Confirming safety of combining UroLift System prior to SAbR for patients with newly diagnosed prostate cancer and a history of BPH, by measuring the acute complication rate of UroLift System implant in patients with BPH undergoing SAbR (within 90 days of treatment completion)

Full description

UroLift System implant will be implanted transurethrally under cystoscopic guidance with a UroLift System Delivery Device by a trained provider. Optimal placement of the implants will be verified cystoscopically. On average, 4-6 UroLift System implants are typically implanted but more or less can be placed per provided discretion, up to a maximum of 10 implants per manufacturer specifications.

Given that patients will also undergo UroLift System placement, patients will be offered to undergo UroLift System, fiducial marker placement and rectal gel spacer placement in one single procedure, under general anesthesia.

SAbR will be performed following placement of UroLift System, prostate fiducials, rectal spacer, and MR/CT simulation, using stereotactic immobilization/localization, rectal enema, prophylactic medication support (tamsulosin, dexamethasone unless contraindicated), bladder filling protocol, and appropriate imaging verification.

Enrollment

15 estimated patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

AJCC 8th edition clinical stage T1 (a, b, or c) or T2 (a, b, or c) adenocarcinoma of the prostate gland, Gleason 3+3 = 6 or 3+4 = 7, with no direct evidence of regional or distant metastases following appropriate staging studies. See Appendix I for details on AJCC 8th Edition staging criteria. T-staging may be assessed by multi-parametric imaging alone if digital rectal examination was deferred
Histologic confirmation of prostate cancer is required by biopsy performed within 18 months of registration.
Age > 45 years.
Eastern Cooperative Oncology Group (ECOG) Performance status 0-1.
American Society of Anesthesia (ASA) physical status score of 1-3
Baseline AUA symptom score ≥ 17 regardless of medical therapy
The serum PSA should be < 20 ng/ml within 120 days of registration
Study entry PSA must not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of ADT or anti-androgen therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasteride; (5) within 5 days of a digital rectal examination
Ultrasound or MRI based volume estimation of prostate gland < 100 grams, regardless of cytoreduction with pharmacotherapy
Ability to undergo general anesthesia for <60 minutes
Ability to understand and the willingness to sign a written informed consent.
All men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.

Exclusion criteria

Contraindications to UroLift System placement including:
Prostate volume >100 cc based on imaging-based estimation
Urethral conditions (e.g. urethral strictures and neoplams) that may prevent insertion of UroLift System delivery system into the bladder
Urinary incontinence due to incompetent sphincter
An active urinary tract infection
Current gross hematuria
In addition to the contraindications if there is a known allergy to nickel, titanium, or stainless steel these patients should be excluded
Prior transurethral resection of the prostate (TURP), median lobe manipulation, simple prostatectomy, or other ablative procedures for benign prostatic hyperplasia.
Foley / self-catheterization in the last 12 months.
Patients with all three intermediate risk factors (PSA >10 and ≤ 20, Gleason 7, clinical stage T2b-T2c) who ALSO have ≥50% of the number of their template biopsy cores positive for cancer are ineligible.
Prior pelvic radiotherapy, chemotherapy, or surgery for prostate cancer.
Current active androgen deprivation therapy