A Single-center Observational Study of Clinical Outcomes of Clinically Localized Prostate Cancer Undergoing HIFU Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment Imaging
研究概览
简要总结
Many reports of clinical outcomes following treatment of localized prostate cancer suffer from lack of prospective long-term data using objective and validated outcome instruments. The purpose of this research database is to prospectively collect data to assess treatment related complications, oncologic outcomes and urinary/sexual function, and identify predictors of complications, oncological control and functional outcomes after Hhigh-intensity focused ultrasound (HIFU) ablation of prostate cancer with the intent to guide further research and improve patient care. We will include subjects who will have a HIFU procedure performed from all Sub-Investigators included in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 95 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males, ages 40-95
- •Evidence of focal prostate cancer confined to the prostate based on MRI imaging and prostate biopsy
- •Patients with clinically localized prostate cancer (no evidence for or concern for metastatic spread of cancer outside of the prostate) that select focal HIFU prostate ablation as their treatment option will be offered inclusion into this prospective data collection research database.
- •Patients who have early (Gleason 6 or 7), low grade cancer that is confined to the prostate.
- •Willing and able to provide consent.
排除标准
- •Patients that are not diagnosed with prostate cancer.
- •Patients that are diagnosed with clinically localized prostate cancer, but select other tratment options as their desired treatment.
- •Patients that are not willing or are not able to give consent.
结局指标
主要结局
Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment Imaging
时间窗: Up to Month 60
Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment Prostate Biopsy
时间窗: Up to Month 60
Number of Participants with New Lesions in the Non-Treated Prostate on Post-Treatment Prostate Biopsy
时间窗: Up to Month 60
Change in Prostate-Specific Antigen (PSA) Levels
时间窗: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Change in Urinary Function Score
时间窗: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Urinary Function is assessed using an 8-item questionnaire; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 0 - 41; lower scores indicate greater urinary function.
Change in Urinary Continence Score
时间窗: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Urinary Continence is assessed using an 2-item questionnaire; each item is rated on a Likert scale from 0-3. The total score is the sum of responses and ranges from 0 - 6; higher scores indicate greater urinary continence.
Change in Sexual Function Score
时间窗: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Sexual Function is assessed using a 6-item questionnaire; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 0 - 29; lower scores indicate greater sexual function.
Change in Ejaculatory Function Score
时间窗: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Ejaculatory Function is assessed using a 4-item questionnaire; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 1 - 20; higher scores indicate greater ejaculatory function.
Change in Sexual Health Inventory for Men (SHIM) Score
时间窗: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
SHIM is a 5-item questionnaire assessing sexual health in men; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 1-20; higher scores indicate greater sexual health.
Decision Regret Score
时间窗: Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Regret toward receiving HIFU ablation focal therapy is assessed using a 5-item questionnaire. Each item is rated on a Likert scale from 1-5; the total score is the sum of responses and ranges from 5-25. Lower scores indicate less regret with the decision.
Change in Prostate-Specific Antigen (PSA) Levels
时间窗: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Change in Urinary Function Score
时间窗: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Urinary Function is assessed using an 8-item questionnaire; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 0 - 41; lower scores indicate greater urinary function.
Change in Urinary Continence Score
时间窗: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Urinary Continence is assessed using an 2-item questionnaire; each item is rated on a Likert scale from 0-3. The total score is the sum of responses and ranges from 0 - 6; higher scores indicate greater urinary continence.
Change in Sexual Function Score
时间窗: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Sexual Function is assessed using a 6-item questionnaire; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 0 - 29; lower scores indicate greater sexual function.
Change in Ejaculatory Function Score
时间窗: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Ejaculatory Function is assessed using a 4-item questionnaire; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 1 - 20; higher scores indicate greater ejaculatory function.
Change in Sexual Health Inventory for Men (SHIM) Score
时间窗: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
SHIM is a 5-item questionnaire assessing sexual health in men; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 1-20; higher scores indicate greater sexual health.
Decision Regret Score
时间窗: Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Regret toward receiving HIFU ablation focal therapy is assessed using a 5-item questionnaire. Each item is rated on a Likert scale from 1-5; the total score is the sum of responses and ranges from 5-25. Lower scores indicate less regret with the decision.
Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment Imaging
时间窗: Up to Month 60
Number of Participants with New Lesions in the Non-Treated Prostate on Post-Treatment Imaging
时间窗: Up to Month 60
Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment Prostate Biopsy
时间窗: Up to Month 60
Number of Participants with New Lesions in the Non-Treated Prostate on Post-Treatment Prostate Biopsy
时间窗: Up to Month 60
次要结局
未报告次要终点