Using UroLift System With Stereotactic Ablative Body Radiotherapy For Men With Prostate Cancer and Benign Prostatic Hyperplasia (BPH): a Phase I Safety Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Safety of UroLift implant when combined with SAbR for men with prostate cancer and benign prostatic hyperplasia
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Non-blinded
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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
结局指标
主要结局
Safety of UroLift implant when combined with SAbR for men with prostate cancer and benign prostatic hyperplasia
时间窗: 90 days
Analyses will be performed for all subjects having received at least one fraction of radiation therapy. The study will use CTCAE version 5.0 for reporting of adverse events and, for reporting purposes, will also capture Clavien-Dindo grading system for the classification of surgical complications for reporting adverse events related to the UroLift System procedure.
次要结局
- Quality of Life with UroLift System(90 days)
研究者
Aurelie Garant
Principal Investigator
University of Texas Southwestern Medical Center