Pilot Study to Determine the Effect of Androgen Deprivation Therapy on the Sensitivity of PSMA-PET Scanning for Patients Undergoing Initial Staging Prior to Robot-Assisted Laparoscopic Radical Prostatectomy and Pelvic Lymphadenectomy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 1. Mean change in maximum standardized uptake value (SUVmax) per lesion as measured by PSMA-PET (POSLUMA®) from baseline to post-ADT
研究概览
简要总结
This is a pilot, non-randomized, two-cohort interventional study in patients who meet the inclusion criteria, using an FDA- approved androgen deprivation agent for a 3 or 6-week course of treatment prior to standard-of-care RALP with PLND. The intent of the study is to determine the effect of ADT on PSMA expression as measured by PSMA-PET scan. A second PSMA-PET scan will be performed after ADT for either 3 or 6 weeks, depending on cohort, prior to RALP and PLND.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men diagnosed with unfavorable intermediate or high-risk prostate cancer where RALP and PLND is planned and consulted with primary urologist
排除标准
- 未提供
研究组 & 干预措施
Cohort A
5 patients (Cohort A) undergo a second study PSMA-PET with POSLUMA® 3 weeks after initiation of ADT and discontinue ADT immediately after the scan is completed.
干预措施: flotufolastat F 18 (Diagnostic Test)
Cohort A
5 patients (Cohort A) undergo a second study PSMA-PET with POSLUMA® 3 weeks after initiation of ADT and discontinue ADT immediately after the scan is completed.
干预措施: Relugolix 120 MG (Drug)
Cohort A
5 patients (Cohort A) undergo a second study PSMA-PET with POSLUMA® 3 weeks after initiation of ADT and discontinue ADT immediately after the scan is completed.
干预措施: Serum PSA and Testosterone (Diagnostic Test)
Cohort B
5 patients (Cohort B) undergo a second study PSMA-PET with POSLUMA® 6 weeks after initiation of ADT and discontinue ADT immediately after the scan is completed.
干预措施: flotufolastat F 18 (Diagnostic Test)
Cohort B
5 patients (Cohort B) undergo a second study PSMA-PET with POSLUMA® 6 weeks after initiation of ADT and discontinue ADT immediately after the scan is completed.
干预措施: Relugolix 120 MG (Drug)
Cohort B
5 patients (Cohort B) undergo a second study PSMA-PET with POSLUMA® 6 weeks after initiation of ADT and discontinue ADT immediately after the scan is completed.
干预措施: Serum PSA and Testosterone (Diagnostic Test)
结局指标
主要结局
1. Mean change in maximum standardized uptake value (SUVmax) per lesion as measured by PSMA-PET (POSLUMA®) from baseline to post-ADT
时间窗: 3-6 weeks
Time Frame: Baseline and 3-6 weeks after initiation of ADT Description: SUVmax will be measured on PSMA-PET for each lesion identified prior to ADT and again after 3 or 6 weeks of ADT (depending on cohort). The primary metric will be the mean change in SUVmax per lesion, per participant. Data will be summarized as mean ± SD, and analyzed using paired statistical testing to determine significance of change.
New lesions not identified pre-treatment are detectable after ADT
时间窗: 3-6 weeks
Time Frame: Baseline and 3-6 weeks post-ADT initiation Description: PSMA-PET scans performed at 3 or 6 weeks after ADT will be compared to baseline scans to identify newly visible lesions. The outcome will be reported as the number and proportion of participants with new lesions. Descriptive statistics will be used to summarize findings.
Establish the optimal duration of ADT necessary to achieve castrate level of testosteroneTime to castration-level testosterone (≤50 ng/dL) following initiation of oral ADT (relugolix 120 mg daily)
时间窗: 3-6 weeks
Time Frame: 0 to 6 weeks after initiation of ADT Description: Serum testosterone will be measured at baseline, 3 weeks, and 6 weeks. The time point at which testosterone ≤50 ng/dL is first achieved will be recorded for each participant. Data will be summarized by frequency, proportion, and median time to castration levels.
Proportion of lesions visible on baseline PSMA-PET that remain detectable on post-ADT PSMA-PET
时间窗: 3-6 weeks
Time Frame: Baseline and 3-6 weeks after initiation of ADT Description: Lesions identified at baseline will be matched to post-ADT PSMA-PET scans. The number and proportion of lesions that remain visible after ADT will be recorded. This will help assess whether ADT obscures PSMA-positive disease on imaging.
次要结局
- Correlation between PSMA-PET findings and surgical pathology(3-6 weeks)
- Concordance between study PSMA-PET and conventional imaging or alternative PSMA-PET agents (if available)(3-6 weeks)