A Phase 4 Open-Label Multicenter Study of PYLARIFY® PET/CT or PET/MRI in Men With Newly Diagnosed Favorable Intermediate Risk (FIR) Prostate Cancer
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 274
- 试验地点
- 14
- 主要终点
- Detection rate
研究概览
简要总结
The purpose of this study is to learn whether PYLARIFY PET imaging (study scan) can safely and accurately detect the presence or absence of prostate cancer growing beyond the prostate gland in men with favorable intermediate risk prostate cancer.
Participants will receive a single dose of PYLARIFY injection followed by a single whole-body PET/CT or PET/MRI scan acquired at 1 to 2 hours after PYLARIFY injection. Participants with positive study scan results that are suspicious for prostate cancer outside of the prostate gland may be asked to undergo additional diagnostic test(s) and/or recommend certain treatment(s) for prostate cancer within 2 to 90 days after the study scan. Participants will be monitored for up to 12 months to collecting information about treatment they receive for prostate cancer and results of regular PSA blood draws if ordered by doctors for up to 12 months after the study scan.
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
- •Patients must have the ability to understand and sign an approved informed consent form (ICF)
- •Patients must have the ability to understand and comply with all protocol requirements
- •Patients must be ≥ 18 years of age
- •Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Patients with life expectancy of at least 13 months as determined by the investigator
- •Patients must have confirmed favorable intermediate risk (FIR) adenocarcinoma of the prostate per 2023 NCCN guidelines. FIR risk group confirmation includes all the following:
- •1 intermediate risk factor (cT2b-cT2c or ISUP Grade Group 2 or PSA 10-20 ng/mL)
- •ISUP Grade Group 1 or 2
- •<50% biopsy cores positive (e.g., <6 of 12 cores)
- •Note: Date of the prostate biopsy should be no sooner that 2 weeks and no later than 3 months prior to PYLARIFY PET imaging
排除标准
- •Patients administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1 (PYLARIFY imaging)
- •Previous Prostate cancer treatment including radiation, androgen deprivation therapy, brachytherapy, surgery, prostate ablation, hormonal therapies or investigational therapy
- •Known hypersensitivity to the components of PYLARIFY or its analogs
- •Patients with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or complete the study
- •Patients who have any radiographic evidence of T3, N1 or M1 disease on SOC imaging (if performed)
研究组 & 干预措施
PYLARIFY PET
干预措施: Piflufolastat F 18 Intravenous Solution [PYLARIFY] (Drug)
结局指标
主要结局
Detection rate
时间窗: Day 1
The proportion of participants with prostate cancer in whom PYLARIFY PET detected previously occult intraprostatic ISUP grade ≥3 lesions as assessed by pathology, or in whom PYLARIFY PET detected the presence of either/or extraprostatic extension, seminal vesicle invasion, regional lymph node involvement, distant metastases, divided by the number of subjects who undergo a PYLARIFY PET scan
次要结局
- Negative predictive value of PYLARIFY(up to day 90)
- Number of participants with Adverse Events(Day 1)
- Specificity of PYLARIFY(up to day 90)
- True detection rate(Day 1)
- Sensitivity of PYLARIFY(up to day 90)
- Change in intended patient clinical management(Day 30)
- Positive predictive value of PYLARIFY(up to day 90)
- Correct localization rate(up to day 90)