Experimental Study to Evaluate the Impact of 18F-PSMA PET / CT in the Management of Patients with Prostate Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Diagnostic role of 18F- PSMA PET /CT (sensitivity)
研究概览
简要总结
Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer.
详细描述
Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer. The aim of this study is to evaluate the additional diagnostic role of 18F- PSMA PET /CT (sensitivity) in patients with prostate cancer with biochemical relapse compared to other diagnostic methods routinely used. The primary objective is to evaluate the sensitivity of 18F-PSMA PET/CT defined as the ratio between the number of 18F-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging.Patients enrolled in the study would benefit from a more accurate but above all earlier diagnosis of disease recurrence sites, thus being able to undergo targeted therapies, with a clear impact on the clinical management of the disease.
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 histologically or cytologically confirmed prostate cancer
- •Male, aged >18 years on the day of signing and dating the informed consent form.
- •Previous radical treatment for prostate cancer (radiotherapy or surgery)
- •Negativity of all the other traditional morphological and functional imaging or doubtful imaging of 18F-FMC PET/CT
- •Patients with PSA progression defined as PSA ≥ 0.2 ng/mL and PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart.
- •Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
- •Participant is willing and able to give informed consent for participation in the study.
排除标准
- •Hormonotherapy in the last 6 months
- •No radiotherapy in the last 6 months.
- •Participation in another clinical trial with any investigational agents within 30 days prior to prior informed consent date
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent.
- •Medical or psychological conditions that would not permit the subject to sign the informed consent
研究组 & 干预措施
18F-PSMA PET/CT
Patients with evidence of biochemical recurrence of prostate cancer radically treated, with negative results to traditional diagnostic methods or doubtful imaging of 18F- Fluoro Methyl Choline (18F-FMC) PET/CT will perform a 18F-PSMA PET/CT as a tool for searching and location of recurrence.
干预措施: 18F-PSMA (Drug)
结局指标
主要结局
Diagnostic role of 18F- PSMA PET /CT (sensitivity)
时间窗: Up to 30 months
Sensitivity of 18F-PSMA PET/CT will be calculated as the ratio between the number of 18F- PSMA PET/CT positive patients and number of patients with radically treated prostate cancer with biochemical relapse and negativity of traditional morphological imaging.
次要结局
- predictive role of 18F-PSMA PET/CT on disease status according to standard imaging and PSA evaluation.(Up to 30 months)
- Sensitivity for different lesion sites(Up to 30 months)
- evaluation of the concordance between 18F-PSMA PET/CT and other methods(Up to 30 months)
- Sensitivity for different PSA values (ranges)(Up to 30 months)
- 18F-PSMA Safety: treated patients undergoing grade 1 to 4 adverse event(Up to 30 months)