EUCTR2019-002000-41-IT进行中（未招募）1 期
Experimental study to evaluate the impact of 18F-PSMA PET / CT in the management of patients with prostate cancer. - F-PSMA
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS0 个研究点目标入组 500 人开始时间: 2021年1月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Patients must have histologically or cytologically confirmed prostate cancer
- •2. Male, aged >18 years on the day of signing and dating the informed consent form.
- •3. Previous radical treatment for prostate cancer (radiotherapy or surgery)
- •4. Negativity of all the other traditional morphological and functional imaging or doubtful imaging of 18F-FMC PET/CT
- •5. 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.
- •6. 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
- •7. Participant is willing and able to give informed consent for participation in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •1. Hormonotherapy in the last 6 months
- •2. No radiotherapy in the last 6 months.
- •3. Participation in another clinical trial with any investigational agents within 30 days prior to prior informed consent date
- •4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent.
- •5. Medical or psychological conditions that would not permit the subject to sign the informed consent.
研究者
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