Status:
COMPLETED
UroLift System With SAbR for Prostate Cancer and BPH
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
NeoTract, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
45+ years
Phase:
NA
Brief Summary
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 i...
Detailed 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 cyst...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05311527
Start Date
January 11 2023
End Date
October 29 2025
Last Update
October 31 2025
Active Locations (1)
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1
University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390