NCT05381103招募中2 期
PSMA-PET to Guide Prostatectomy: A Randomized Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 288
- 试验地点
- 2
- 主要终点
- IIEF-EF sub scale score
研究概览
简要总结
In this study, 196 patients will be randomized 1:1 to either having only the standard of care MRI prior to surgery versus having the standard of care MRI and the PSMA PET scan. PET (and MRI) findings will be validated against whole mount pathology. Pre-surgical imaging findings will also be evaluated in the context of affecting subsequent surgical plans and impacting actual patient outcomes.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Significant prostate cancer:
- •Gleason 3+4 ≥1 core with pattern 4 ≥20%
- •Gleason 3+4 ≥1 core with ≥50% total involvement of core OR ≥3 cores of Gleason 3+4 OR
- •NCCN unfavorable intermediate risk OR
- •Any Gleason 4+3, 4+4, 4+5, 5+4, or 5+5 AND
- •Baseline sexual function (IIEF-EF > 17): No erectile dysfunction OR mild-to- moderate erectile dysfunction (International Index of Erectile Function Domain ≥ 17) AND
- •The patient desires to maintain erections following treatment
- •Planned to undergo a standard of care MRI or recently completed standard of care MRI within 6 months of scheduled date of surgery. Note: For subjects whose SOC MRI is not within 6 months or not 3Tesla, they may be enrolled in the study and the MRI will be repeated as a research study. The research MRI will not be billed to the subject's insurance, but will be scheduled at IU ORI, at no cost to study participant.
- •Planned Prostatectomy candidate per treating oncologist with prostatectomy planned within 90 days of consent.
排除标准
- •Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
- •Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed, since MRI is required for comparison).
- •Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
结局指标
主要结局
IIEF-EF sub scale score
时间窗: 18 months
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
次要结局
- Change in treatment plan(1 month)
- Ratio of positive surgical margins to nerve bundles spared(1 month)
- EPE detection(1 month)
- Incontinence bother(18 months)
- Surgical margins(1 month)
- Incontinence: using 0-1 pads per day(18 months)
- Urgency/frequency(18 months)
- Erectile dysfunction: ability to achieve erection sufficient for penetration(18 months)
- Overall mental and physical health(18 months)
研究者
研究点 (2)
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