A Phase 2 Study of 68Ga-PSMA-11 PET in Patients With Metastatic Castration Resistant Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Thomas Hope
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Mean Maximum Standard Uptake Value (SUVmax)
研究概览
简要总结
This phase II trial studies the use of 68Ga-PSMA-11 positron emission tomography (PET) in diagnosing patients with prostate cancer that continues to grow despite the surgical removal of the testes or medical intervention to block androgen production (castration resistant), and has spread to other places in the body (metastatic). 68Ga- PSMA-11 is a new imaging agent that may help get more detailed pictures of the tumor. This trial aims to see whether using 68Ga-PSMA-11 PET scans may help doctors learn more about where disease is located in the body.
详细描述
PRIMARY OBJECTIVE:
I. To determine whether the percent change from baseline to 16 weeks (+/- 8 weeks) in maximum standard uptake value (SUVmax) averaged across up to 16 lesions per patient (SUVmax-ave) is associated with >= 50% decline from baseline in serum prostate specific antigen (PSA50) response.
SECONDARY OBJECTIVES:
I. To determine whether the percent change from baseline in SUVmax-ave on PSMA PET is associated with time-to-event endpoints including PSA progression-free survival and overall survival.
II. To determine whether the percent change from baseline in SUVmax on PSMA PET is associated with objective response by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 on a per-lesion basis among measurable soft tissue lesions present at baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Sub-cohort A1: Patients must have baseline evaluations performed within 12 weeks prior to the start of systemic therapy.
- •Sub-cohort A2: Patients must meet all the following requirements:
- •Have had a baseline pre-treatment 68Ga-PSMA-11 PET scan and PSA measurement performed within 12 weeks prior to the start of current systemic therapy.
- •Able to have an on-treatment 68Ga-PSMA-11 PET and a PSA measurement within 16 weeks (+/- 8 weeks) after the start of current systemic therapy.
- •Note: The screening period for sub-cohort A2 is within 24 weeks after the patient started their current systemic therapy.
- •Patients must have progressive castration resistant prostate cancer, according to PCWG3 criteria.
- •Patients must have planned initiation of systemic treatment (sub-cohort A1), or ongoing systemic treatment (sub-cohort A2) for castration resistant prostate cancer within 12 weeks of baseline Ga-PSMA PET.
- •Patients must have at least one metastatic lesion with PSMA uptake at or above the blood pool on their baseline PSMA PET scan.
- •The patient must be able and willing to comply with study procedures and provide signed and dated informed consent.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Patient must be Aged 18 years or older at the time of study entry.
- •Patients who undergo optional metastatic tumor biopsy following completion of baseline Ga-PSMA PET must additionally meet all of the following criteria:
- •Presence of one or more metastases by standard radiographic scans that is safely accessible to tumor biopsy in the judgment of treating clinician and/or Interventional Radiology.
- •No history of radiation therapy to the target metastatic lesion selected for tumor biopsy.
- •No contra-indication to biopsy including uncontrolled bleeding diathesis.
- •Platelets > 75,000/ul and prothrombin time (PT) or institution normalized ratio (INR) and a partial thromboplastin time (PTT) < 1.5 times the institutional upper limit of normal (ULN) within 14 days prior to biopsy.
排除标准
- •Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
- •Patients with any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
- •Patients with any contra-indication to magnetic resonance imaging (MRI) (e.g. pacemaker placement, severe claustrophobia) Note: The exclusion criteria above (3) is only applicable for patients scheduled for a Positron Emission Tomography (PET) MRI (PET/MRI).
研究组 & 干预措施
Experimental (68Ga-PSMA-11 PET)
Patients receive gallium 68Ga-PSMA-11 IV and undergo PET at baseline, 16 weeks after initiating therapy, and at time of disease progression.
干预措施: 68Ga-PSMA-11 (Drug)
Experimental (68Ga-PSMA-11 PET)
Patients receive gallium 68Ga-PSMA-11 IV and undergo PET at baseline, 16 weeks after initiating therapy, and at time of disease progression.
干预措施: Positron Emission Tomography (PET) (Procedure)
结局指标
主要结局
Mean Maximum Standard Uptake Value (SUVmax)
时间窗: Baseline, and up to 16 weeks after initiation of therapy
The mean SUVmax and standard deviation across the primary tumor and the 5 largest lesions in each of three metastatic sites (nodal, visceral and osseous; for a maximum of 16 lesions per patient) will be descriptively reported.
Median SUVmax
时间窗: Baseline, and up to 16 weeks after initiation of therapy
The median and range of SUVmax across the primary tumor and the 5 largest lesions in each of three metastatic sites (nodal, visceral and osseous; for a maximum of 16 lesions per patient) will be descriptively reported.
Percentage of Participants Who Progressed by Prostate-specific Antigen (PSA) Response Group
时间窗: Baseline, and up to 16 weeks after initiation of therapy
The percent of participants who fall into the PSA50 responders vs. non-responders based on PSMA treatment response criteria (PPP) for progression status will be reported. PPP uses 3 different criteria to determine response: 1) Appearance of 2 or more new PSMA positive distant lesions, 2) Appearance of 1 new PSMA positive lesion plus consistent clinical and/or laboratory data and recommended confirmation by biopsy or correlative imaging within 3 months of PSMA PET, and 3) Increase in size or PSMA uptake of 1 or more existing lesions by 30% plus consistent clinical and/or laboratory data and/or confirmation by biopsy or correlative imaging within 3 months of PSMA PET.
次要结局
- Comparison of Change in SUVmax-ave Group on Progression Free Survival (PFS)(Up to 24 months)
- Comparison of Change in SUVmax-ave Group on Overall Survival (OS)(Up to 24 months)
- Comparison Between Mean Percent Change in SUVmax With Objective Response Group(Baseline, and up to 16 weeks after initiation of therapy)
研究者
Thomas Hope
Co-Principal Investigator (IND Holder)
University of California, San Francisco