Prospective Single Institutional Study Evaluating the Outcomes for Patients Undergoing Ablative Therapies in the Management of Clinically Localized Prostate Cancer in the Primary and Salvage Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Oncologic outcomes as assessed by the rate of advancement to systemic therapy or radical salvage therapies (primary setting)
研究概览
简要总结
This study will be designed to define the efficacy and safety of ablative therapies in the management of localized prostate cancer and comprehensively evaluate quality of life outcomes and oncologic control following treatment.
详细描述
This study will be designed to define the efficacy and safety of ablative therapies in the management of localized prostate cancer and comprehensively evaluate quality of life outcomes and oncologic control following treatment.
There are several commercially available standard of care treatments available for local therapy of the prostate. Ablative therapies may be delivered via a whole gland or focal approach by systems including cryoablation (CA), brachytherapy, irreversible electroporation (IRE), high intensity focused ultrasound (HIFU), MRI-guided transurethral ultrasound ablation (TULSA) procedure or future novel prostate ablation systems.
These are single, outpatient treatments lasting between 2-4 hours and include treatment planning and energy delivery under guidance and are either administered via transperineally approach (cryoablation, IRE, brachytherapy) or via the urethral (TULSA-Pro) or rectum (HIFU).
This study protocol will not include experimental therapy and the enrolled subjects will undergo the ablative therapy as part of their standard of care treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with histologically confirmed prostate adenocarcinoma diagnosed on prostate biopsy
- •Men with histologically confirmed local recurrence of prostate cancer diagnosed on prostate biopsy and standard of care imaging excluding locoregional or metastatic disease
- •Age 18-90 years.
- •Life expectancy > 1 year
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Anatomic abnormalities that do not allow for focal ablation
- •Evidence of non-organ confined disease that is not feasible for ablation
- •Has active urinary traction infection
研究组 & 干预措施
Ablative Therapy Group
Enrolled subjects will undergo the ablative therapy as part of their standard of care treatment
结局指标
主要结局
Oncologic outcomes as assessed by the rate of advancement to systemic therapy or radical salvage therapies (primary setting)
时间窗: 3 years post treatment
Oncologic outcomes will be assessed by the rate of advancement to systemic therapy or radical salvage therapies which is defined by prostatectomy, radiation or hormone therapy.
Oncologic outcomes as assessed by the rate of progression to systemic therapy or radical salvage therapies (salvage setting)
时间窗: 3 years post treatment
Oncologic outcomes will be assessed by the rate of progression to systemic therapy or radical salvage therapies which is defined by prostatectomy, radiation or hormone therapy.
Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (primary setting)
时间窗: 12 months post treatment
Oncologic outcomes will be assessed by the rate of negative in-field biopsy at 12 months which is defined by the Delphi consensus criterion of absence of clinically significant disease (≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is insignificant)
Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (primary setting)
时间窗: Baseline and 12 months post treatment
Change in urinary function is measured by International Prostate Symptom Score (IPSS) questionnaire which measures urinary symptoms and continence and the scores range from 0 to 35. A change \> 3 points between baseline and follow-up assessments is defined as meaningful for the IPSS. Therefore, increases in IPSS scores larger than 3 points will be categorized as reduced urinary function (worse outcome).
Change in erectile function as measured by International Index of Erectile Function (IIEF-5) score questionnaire (primary setting)
时间窗: Baseline and 12 months post treatment
Change in erectile function is measured by International Index of Erectile Function (IIEF-5) score questionnaire which classifies patients into five severity levels ranging from none (22-25 points) to severe (5-7 points). Patients whose IIEF-5 levels worsen from baseline to follow-up will be categorized as having reduced erectile function.
Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (salvage setting)
时间窗: 12 months post treatment
Oncologic outcomes will be assessed by the rate of negative in-field biopsy at 12 months which is defined by the Delphi consensus criterion of absence of clinically significant disease (≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is insignificant)
Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (salvage setting)
时间窗: Baseline and 12 months post treatment
Change in urinary function is measured by International Prostate Symptom Score (IPSS) questionnaire which measures urinary symptoms and continence and the scores range from 0 to 35. A change \> 3 points between baseline and follow-up assessments is defined as meaningful for the IPSS. Therefore, increases in IPSS scores larger than 3 points will be categorized as reduced urinary function (worse outcome).
Change in erectile function as measured by International Index of Erectile Function (IIEF-5) score questionnaire (salvage setting)
时间窗: Baseline and 12 months post treatment
Change in erectile function is measured by International Index of Erectile Function (IIEF-5) score questionnaire which classifies patients into five severity levels ranging from none (22-25 points) to severe (5-7 points). Patients whose IIEF-5 levels worsen from baseline to follow-up will be categorized as having reduced erectile function.
次要结局
- Number of participants with adverse events or short-term complications (primary setting)(30 days post treatment)
- Number of participants with adverse events or short-term complications (salvage setting)(30 days post treatment)
- Number of participants with adverse events or long-term complications (primary setting)(3 years post-treatment)
- Number of participants undergoing combined treatment of the transitional zone (TZ ) due to bladder outlet obstruction caused by Benign prostatic hyperplasia (BPH)(Baseline and 12 months post treatment)
- Number of participants with adverse events or long-term complications (salvage setting)(3 years post-treatment)
研究者
Daniel Segal
Assistant Professor
University of Texas Southwestern Medical Center