MC230504 Safe Omission of Pelvic Lymph Node Dissection (SOuND ) During Radical Prostatectomy: Diagnostic Accuracy of rhPSMA-7.3(18F) PET/CT, mpMRI and Patient Clinical Factors to Predict Lymph Node Metastasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Sensitivity of flotufolastat F-18 gallium (18F-rhPSMA-7.3) positron emission tomography (PET)/magnetic resonance (MRI) for the detection of lymph node metastasis
研究概览
简要总结
This clinical trial evaluates the use of an imaging scan (18F-rhPSMA-7.3 positron emission tomography [PET]/magnetic resonance imaging [MRI]) for identifying patients who are at risk of having their disease spread to the lymph nodes in those undergoing radical prostatectomy for prostate cancer that has not spread to other parts of the body (localized). Prostate specific membrane antigen (PSMA) PET/computed tomography (CT) has emerged as an option to stage newly diagnosed high risk prostate cancer patients. PSMA PET/CT has demonstrated improved diagnostic accuracy for identifying metastasis. PET is procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is used. Because cancer cells often use more glucose than normal cells, the pictures can be used to find cancer cells in the body. MRI is procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. This study may help researchers learn whether 18F-rhPSMA-7.3 PET/ MRI may improve predicting which patients are at risk of lymph node metastases and who are suitable candidates for pelvic lymph node dissection in patients with localized high-risk prostate cancer undergoing radical prostatectomy.
详细描述
PRIMARY OBJECTIVE:
I. To investigate the diagnostic ability of flotufolastat F-18 gallium (18F-rhPSMA-7.3) PSMA PET/MRI prior to radical prostatectomy in newly diagnosed, high-risk prostate cancer patients.
SECONDARY OBJECTIVES:
I. Calculating the specificity, positive-predictive value, and negative-predictive value for the detection of lymph node positivity.
II. Investigating the rates of biochemical recurrence (BCR) as measured by post-operative prostate specific antigen (PSA) (PSA > 0.20) at pre-defined timepoints in patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects ≥ 30 and ≤ 85 years old
- •Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy with extended lymph node dissection)
- •Primary diagnosis of untreated American Urological Association (AUA) guidelines high-risk localized prostate cancer, hormone-naïve prostate cancer via contrast enhanced prostate MRI + tissue sampling
- •Planned elective radical prostatectomy with extended pelvic lymph node dissection
- •Clinical oligometastatic disease with ≤ 3 nodes positive on preoperative standard of care imaging of prostate region within 6 months of surgery
- •Patient agrees to comply with the investigator instructions
- •Patient agrees to comply with the follow-up surveillance schedule
- •Have ability to provide full written consent
排除标准
- •High-risk cancer planned for neoadjuvant therapy
- •Patients with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study
- •Patients that have had prior hormonal therapy such as Lupron or oral antiandrogens ≤ 12 weeks prior to registration
- •Clinical oligometastatic disease with > 3 nodes positive preoperative standard of care imaging of prostate region
- •Previous history of pelvic radiation
- •Patients with obesity defined as body mass index (BMI) > 40 kg/m^2
- •History of prior laparoscopic inguinal hernia repair with mesh
- •Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period
- •Inability to lie still for 75 minutes during 18F-rhPSMA-7.3 PSMA PET-MRI imaging
- •Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments
- •Has any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment
- •Received administration of an investigational drug within 30 days prior to study registration, and/or has planned administration of another investigational product or procedure during participation in this study
研究组 & 干预措施
Screening (18F-rhPSMA-7.3 PET/MRI)
Patients receive 18F-rhPSMA-7.3 IV and undergo PET/MRI up to 30 days prior to SOC robotic radical prostatectomy with bilateral pelvic lymph node dissection. Patients also undergo CT/MRI or bone scan/PT, as well as tissue collection during screening.
干预措施: Bilateral Pelvic Lymph Node Dissection (Procedure)
Screening (18F-rhPSMA-7.3 PET/MRI)
Patients receive 18F-rhPSMA-7.3 IV and undergo PET/MRI up to 30 days prior to SOC robotic radical prostatectomy with bilateral pelvic lymph node dissection. Patients also undergo CT/MRI or bone scan/PT, as well as tissue collection during screening.
干预措施: Biospecimen Collection (Procedure)
Screening (18F-rhPSMA-7.3 PET/MRI)
Patients receive 18F-rhPSMA-7.3 IV and undergo PET/MRI up to 30 days prior to SOC robotic radical prostatectomy with bilateral pelvic lymph node dissection. Patients also undergo CT/MRI or bone scan/PT, as well as tissue collection during screening.
干预措施: Bone Scan (Procedure)
Screening (18F-rhPSMA-7.3 PET/MRI)
Patients receive 18F-rhPSMA-7.3 IV and undergo PET/MRI up to 30 days prior to SOC robotic radical prostatectomy with bilateral pelvic lymph node dissection. Patients also undergo CT/MRI or bone scan/PT, as well as tissue collection during screening.
干预措施: Computed Tomography (Procedure)
Screening (18F-rhPSMA-7.3 PET/MRI)
Patients receive 18F-rhPSMA-7.3 IV and undergo PET/MRI up to 30 days prior to SOC robotic radical prostatectomy with bilateral pelvic lymph node dissection. Patients also undergo CT/MRI or bone scan/PT, as well as tissue collection during screening.
干预措施: Electronic Health Record Review (Other)
Screening (18F-rhPSMA-7.3 PET/MRI)
Patients receive 18F-rhPSMA-7.3 IV and undergo PET/MRI up to 30 days prior to SOC robotic radical prostatectomy with bilateral pelvic lymph node dissection. Patients also undergo CT/MRI or bone scan/PT, as well as tissue collection during screening.
干预措施: Flotufolastat F-18 Gallium (Other)
Screening (18F-rhPSMA-7.3 PET/MRI)
Patients receive 18F-rhPSMA-7.3 IV and undergo PET/MRI up to 30 days prior to SOC robotic radical prostatectomy with bilateral pelvic lymph node dissection. Patients also undergo CT/MRI or bone scan/PT, as well as tissue collection during screening.
干预措施: Laparoscopic Radical Prostatectomy with Robotics (Procedure)
Screening (18F-rhPSMA-7.3 PET/MRI)
Patients receive 18F-rhPSMA-7.3 IV and undergo PET/MRI up to 30 days prior to SOC robotic radical prostatectomy with bilateral pelvic lymph node dissection. Patients also undergo CT/MRI or bone scan/PT, as well as tissue collection during screening.
干预措施: Magnetic Resonance Imaging (Procedure)
Screening (18F-rhPSMA-7.3 PET/MRI)
Patients receive 18F-rhPSMA-7.3 IV and undergo PET/MRI up to 30 days prior to SOC robotic radical prostatectomy with bilateral pelvic lymph node dissection. Patients also undergo CT/MRI or bone scan/PT, as well as tissue collection during screening.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Sensitivity of flotufolastat F-18 gallium (18F-rhPSMA-7.3) positron emission tomography (PET)/magnetic resonance (MRI) for the detection of lymph node metastasis
时间窗: Up to 12 months
Defined as the presence of lymph node positivity determined on final pathologic analysis compared to findings on preoperative 18F-rhPSMA-7.3 PSMA PET/MRI. Continuous variables will be summarized as mean (standard deviation) or median (range) while categorical variables will be reported as frequency (percentage).
次要结局
- Specificity(Up to 12 months)
- Positive predictive value//negative predictive value (PPV/NPV)(Up to 120 months)
- Prostate specific antigen (PSA): < 5, 5-10, 10-20, > 20(Up to 12 months)
- Gleason score(Up to 12 months)
- Digital rectal examination(Up to 12 months)
- Rates of biochemical recurrent disease (BCR)(Up to 12 months)
- Number of patients where management has changed(Up to 12 months)