UroLift System With SAbR for Prostate Cancer and BPH

Prior treatment

• Prior transurethral resection of the prostate (TURP), median lobe manipulation, simple prostatectomy, or other ablative procedures for benign prostatic hyperplasia.
• Prior pelvic radiotherapy, chemotherapy, or surgery for prostate cancer.
• Current active androgen deprivation therapy

Other illness

• Urethral conditions (e.g. urethral strictures and neoplams) that may prevent insertion of UroLift System delivery system into the bladder
• 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
• 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.

Other

• Contraindications to UroLift System placement including:
• Prostate volume \>100 cc based on imaging-based estimation
• Urinary incontinence due to incompetent sphincter
• Foley / self-catheterization in the last 12 months.

• 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.