EUCTR2019-003382-18-NL进行中（未招募）1 期
A prospective, Phase 3, multi-center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA-7.3 (18F) PET ligand in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy
Blue Earth Diagnostics Ireland Ltd.0 个研究点目标入组 316 人开始时间: 2020年5月27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
- 316
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. Patient willing to provide signed informed consent and willing to comply with all required study schedule events, where safe and feasible.
- •2. Patient is male and aged >18 years old.
- •3. Patient with a history of localized adenocarcinoma of the prostate with prior curative intent treatment, experiencing BCR of PCa potentially eligible for salvage therapy with curative intent, following prior treatment with one or more of the following: a) RP, b) RP plus adjuvant RT, c) RP plus adjuvant androgen deprivation therapy (ADT), d) external beam radiation therapy or e) focal gland therapies (e.g. brachytherapy, high-intensity focused ultrasound [HIFU])
- •- At least 6 weeks must have elapsed after RP.
- •- If previously taking ADT, it should have been discontinued at least 16 weeks prior to
- •- In the case of focal gland therapies (e.g. HIFU) and RT, the treatment will have
- •occurred at least 1 year prior to screening.
- •4. An elevated PSA, clinically suspicious for biochemically recurrent disease, that meets one of the following conditions:
- •- Following RP with or without adjuvant or salvage therapy: PSA =0.2 ng/mL followed by a subsequent confirmatory PSA value =0.2 ng/mL.
- •- Following RT (e.g. radical radiotherapy or brachytherapy)as the primary treatment: nadir +2 ng/mL.
- •- Following focal gland therapies (e.g. HIFU) as the primary treatment: nadir +2 ng/mL.
- •5. Patient willing to undergo biopsy for histological confirmation of rhPSMA-7.3 (18F) PET findings, where safe and feasible.
- •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 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 126
排除标准
- •1. Patients with any medical condition or circumstance (including receiving an IP) that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements.
- •2. Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan.
- •3. Patients currently receiving ADT (defined as surgical orchidectomy; luteinizing hormone-releasing hormone [LHRH] agonist alone [continuous or intermittent]; LHRH antagonist alone [continuous or intermittent]; administration or use of a first generation or second generation anti-androgen alone or in combination with an LHRH agonist/antagonist).
- •4. Patients participating in an interventional clinical trial within 30 days and having received an IP within five biological half-lives prior to administration of rhPSMA-7.3 (18F).
- •5. Patients with known hypersensitivity to the active substance or to any of the excipients of the IP.
研究者
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