A Pilot Study of rhPSMA-PET MRI Imaging for the Detection of Clinically Actionable Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Radio-pathological correlation between positron emession tomography-magnetic resonance imaging (PET-MRI) and prostate biopsy or radical prostatectomy
研究概览
简要总结
This clinical trial evaluates whether positron emission tomography-magnetic resonance imaging (PET-MRI) using the radioactive drug radiohybrid prostate-specific membrane antigen (rhPSMA)-7.3 may help in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer who are candidates for active surveillance. A PET scan is a test that uses a radioactive drug and a computer to create images of how organs and tissues in the body are functioning. The radioactive drug used in this study, rhPSMA-7.3, attaches to the abnormal cells in the body at a different rate than normal cells which allows the scanner to create a detailed picture of how the body is working. An MRI scan uses strong magnets and computers to create detailed images of the soft tissue in your body. A multiparametric (mp)MRI is a type of MRI scan that creates a more detailed picture of the prostate gland. Using rhPSMA-73 with PET-MRI and mpMRI may be more effective in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer.
详细描述
PRIMARY OBJECTIVE:
I. Measure the rate of rhPSMA-7.3-PET-MRI identified Gleason Grade Group (GG) 3-5 disease on pathology or locally advanced disease. A threshold rate of 15% detection will be considered clinically significant.
SEONDARY OBJECTIVE:
I. Assessment of safety.
EXPLORATORY OBJECTIVES:
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
盲法说明
A read will completed for the PET portion of the examination by a nuclear medicine trained radiologist who is blinded to the mpMRI portion of the exam.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men (Eastern Cooperative Oncology Group [ECOG] 0-1), >= 18 years old with at least 10 year life expectancy
- •Histologically proven Gleason Grade Group 1 or 2 adenocarcinoma of the prostate
- •Last prostate cancer containing biopsy performed within 3-15 months (mo.) prior to screening. Biopsy must have been >= 10 core biopsy and informed by prior mpMRI
- •Prostate cancer categorized as low risk or favorable risk by National Comprehensive Cancer Network (NCCN) criteria (low risk is defined as T1c-T2a, prostate-specific antigen [PSA] < 10ng/ml, Gleason Grade Group 1 [Gleason 3+3=6] disease) and favorable intermediate risk as having no more than one of the following intermediate risk features, clinical T2b-T2c disease, PSA 10-20ng/ml, Gleason Grade Group 2 [Gleason score 3+4=7])
- •Decipher genomic classifier score from prior biopsy >= 0.45
- •Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures
- •Concurrent diseases and malignancies are permitted
- •Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study
- •Willing to undergo prostate biopsy prior to non-surgical treatment of prostate cancer and within 90 days of PET-MRI imaging
排除标准
- •Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer
- •NCCN very low risk category (T1c and Gleason Grade Group 1 [Gleason score 3+3=6], PSA < 10 ng/mL, fewer than 3 prostate biopsy cores positive, =< 50% cancer in any core, PSA density < 0.15 ng/mL/g)
- •Decipher score < 0.45
- •Prior bladder outlet procedure (i.e,. holmium laser enucleation of the prostate [HoLEP], transurethral resection of the prostate [TURP], Urolift, Rezum)
- •Prohibited medications: use of 5 alpha reductase inhibitor or androgen deprivation therapy (i.e., leuprolide, relugolix) within 1 month of screening
- •Contra-indication or relative contra-indication to MRI (i.e., pacemaker)
- •History of hip replacement
- •Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening
研究组 & 干预措施
Treatment (rhPSMA, PET-MRI, mpMRI)
Patients receive rhPSMA-7.3 IV then undergo PET-MRI and mpMRI of the prostate on study. Patients also undergo Decipher test at screening and MRI-PET prostate biopsy or radical prostatectomy within 90 days per standard of care.
干预措施: Biopsy of Prostate (Procedure)
Treatment (rhPSMA, PET-MRI, mpMRI)
Patients receive rhPSMA-7.3 IV then undergo PET-MRI and mpMRI of the prostate on study. Patients also undergo Decipher test at screening and MRI-PET prostate biopsy or radical prostatectomy within 90 days per standard of care.
干预措施: Flotufolastat F-18 Gallium (Other)
Treatment (rhPSMA, PET-MRI, mpMRI)
Patients receive rhPSMA-7.3 IV then undergo PET-MRI and mpMRI of the prostate on study. Patients also undergo Decipher test at screening and MRI-PET prostate biopsy or radical prostatectomy within 90 days per standard of care.
干预措施: Magnetic Resonance Imaging (Procedure)
Treatment (rhPSMA, PET-MRI, mpMRI)
Patients receive rhPSMA-7.3 IV then undergo PET-MRI and mpMRI of the prostate on study. Patients also undergo Decipher test at screening and MRI-PET prostate biopsy or radical prostatectomy within 90 days per standard of care.
干预措施: Multiparametric Magnetic Resonance Imaging (Procedure)
Treatment (rhPSMA, PET-MRI, mpMRI)
Patients receive rhPSMA-7.3 IV then undergo PET-MRI and mpMRI of the prostate on study. Patients also undergo Decipher test at screening and MRI-PET prostate biopsy or radical prostatectomy within 90 days per standard of care.
干预措施: Positron Emission Tomography (Procedure)
Treatment (rhPSMA, PET-MRI, mpMRI)
Patients receive rhPSMA-7.3 IV then undergo PET-MRI and mpMRI of the prostate on study. Patients also undergo Decipher test at screening and MRI-PET prostate biopsy or radical prostatectomy within 90 days per standard of care.
干预措施: Radical Prostatectomy (Procedure)
Treatment (rhPSMA, PET-MRI, mpMRI)
Patients receive rhPSMA-7.3 IV then undergo PET-MRI and mpMRI of the prostate on study. Patients also undergo Decipher test at screening and MRI-PET prostate biopsy or radical prostatectomy within 90 days per standard of care.
干预措施: Decipher Prostate Cancer Test (Genetic)
结局指标
主要结局
Radio-pathological correlation between positron emession tomography-magnetic resonance imaging (PET-MRI) and prostate biopsy or radical prostatectomy
时间窗: Up to 90 days
Will report agreement between pathology and imaging and ability of radiohybrid prostate-specific membrane antigen-7-PET-MRI to identify higher grade and stage disease as a raw percentage.
次要结局
- Incidence of Treatment-Related Adverse Events [Safety and Tolerability](Within 24 hours of radio-tracer injection)
研究者
Ashley Ross MD, PhD
Associate Professor, Department of Urology
Northwestern University