A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches: Transrectal Ultrasound-guided Biopsy Compared With a Transperineal Approach
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Gleason Grade
研究概览
简要总结
This randomized trial will compare the safety and efficacy of TPM versus TRUS biopsies performed in the outpatient setting. Primary endpoints will be pain as well as detection of clinically significant disease (defined as Gleason Score >=7 or cancer core length >=6 mm). Secondary endpoints will be detection of any prostate cancer, hospital re-admissions within 30 days, aborted procedures due to discomfort, procedure time, adverse events including hematuria, urinary retention, hematospermia, hematochezia, and infection, and patient-reported outcomes as measured on validated instruments such as International Prostate Symptom Scores (IPSS) and International Index of Erectile Function (IIEF-5). In men who subsequently elect to undergo radical prostatectomy for definitive treatment of their prostate cancer, Gleason scores at final pathology will be correlated to the Gleason scores obtained at time of biopsy.
详细描述
The feasibility of outpatient TPM has been well demonstrated.(Bianco & Martínez-Salamanca, 2016; Merrick et al., 2016; Smith et al., 2014) New technology now allows for fusion of MRI images with TPM devices, allowing for targeting of cancerous-appearing lesions on MRI. Such technology that fuses MRI-imaging with TRUS biopsy has become routine in U.S. clinical practice, with improved cancer detection rates as compared with standard TRUS.(Ahmed et al., 2017; Robertson, Emberton, & Moore, 2013)
This randomized trial will compare the safety and efficacy of TPM versus TRUS biopsies performed in the outpatient setting. Men will be randomized to receiving either TPM or TRUS targeted biopsy. All men will receive a urine culture within 2 weeks of biopsy and will be started on antibiotic prophylaxis prior to biopsy in accordance with AUA antimicrobial prophylaxis guidelines. Men with a positive urine culture will be treated with culture-specific antibiotics and must have a documented negative urine culture prior to biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men 18 years or older with suspicion for prostate cancer based upon an elevated PSA, abnormal digital rectal examination, abnormal MRI
- •Men on active surveillance with indication for biopsy
排除标准
- •Men with active urinary tract infection, metastatic prostate cancer, history of colorectal surgery limiting insertion of transrectal probe, evidence of acute or chronic prostatitis, or concern for perineal cellulitis or fistula
- •Men unfit to undergo prostate biopsy under local anesthesia
- •Men with prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation
- •Men with contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease)
结局指标
主要结局
Gleason Grade
时间窗: 7 days post-biopsy
Detection of clinically significant disease Typical Gleason Scores range from 6-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly. * Scores of 6 or less describe cancer cells that look similar to normal cells and suggest that the cancer is likely to grow slowly. * A score of 7 suggests and intermediate risk for aggressive cancer. Scoring a 7 means that the primary score (largest section of the tumor) scored a 3 or 4. Tumors with a primary score of 3 and a secondary score of 4 have a fairly good outlook, whereas cancers with a primary Gleason Score of 4 and a secondary score of 3, are more likely to grow and spread. * Scores of 8 or higher describe cancers that are likely to spread more rapidly, these cancers are often referred to as poorly differentiated or high grade.
次要结局
- Patient-reported Erectile Function, as Measured by International Index of Erectile Function (IIEF-5) Questionnaire(baseline, 7 days post-biopsy, 30 days post-biopsy)
- Patient-reported Pain, as Measured on a 0-10 Likert Scale(At time of local anesthesia administration, initiation of biopsy, immediately following biopsy, 7 days post-biopsy, 3 months post-biopsy)
- Patient-reported Symptoms, as Measured by International Prostate Symptom Scores (IPSS) Questionnaire(baseline, 7 days post-biopsy, 30 days post-biopsy)
- Adverse Events(initiation of biopsy, immediately following biopsy, 7 days post-biopsy, 30 days post-biopsy)
- Patient-reported Quality of Life, as Measured by EPIC-CP Questionnaire(baseline, 7 days post-biopsy, 30 days post-biopsy)