EUCTR2017-005010-59-GB进行中（未招募）1 期
A Phase II, Open-label Study to Assess Safety and Clinical Utility of 68Ga-THP-PSMA PET/CT in Patients with High Risk Primary Prostate Cancer or Biochemical Recurrence after Radical treatment
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
入选标准
- •Group A: Inclusion Criteria
- •- The patient is a male equal to/ over 18 years old.
- •- Histologically proven adenocarcinoma of the prostate gland.
- •- Gleason score 4+3 and above, or PSA >20 ng/mL or clinical stage >T2c.
- •- The patient is to be suitable for surgical treatment as part of their standard of care management.
- •- The patient is able and willing to comply with study procedures, and signature and dating of the informed consent form (ICF) is obtained before any study-related procedure is performed.
- •- The patient has a normal or clinically acceptable medical history and vital signs findings at screening (up to 4 weeks before administration of 68Ga-THP-PSMA).
- •- The patient should not have received hormone therapy related to PCa within the past 3 months (other types of hormone therapy are not excluded).
- •- The patient’s Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 2.
- •Group B: Inclusion Criteria
- •- The patient is a male equal to or over 18 years old.
- •- The patient has had an original diagnosis of PCa, underwent radical curative therapy at least 3 months before enrolment, and has been diagnosed with BCR based on:
- •- Post RP: 2 consecutive rises in PSA with a 3-month interval in between reads and final PSA >0.l ng/mL or PSA level 0.5 mg/mL at time of recruitment. The PSA doubling time will be calculated using the Memorial Sloan Kettering Cancer
- •Center nomogram based on a minimum of 2 PSA levels within 12 months of screening, taken after the last recorded nadir PSA available at time of screening.
- •- The patient has not had previous recurrences of PCa, i.e. this is the first diagnosis of BCR.
- •- The patient is being considered for radical salvage therapy.
- •- The patient is able and willing to comply with study procedures, and signature and dating of the ICF is obtained before any study-related procedure is performed.
- •- The patient’s ECOG performance status is 0 to 2.
- •The patient should not have received androgen-deprivation therapy within 3 months of screening.
- •- The patient has a normal or clinically acceptable medical history and vital signs findings at screening (up to 14 days before administration of 68Ga-THP-PSMA).
- •- The patient should not have received hormone therapy related to PCa within the past 3 months (other types of hormone therapy are not excluded).
- •Group C: Inclusion Criteria
- •- The subject is a male equal to or over 18 years old.
- •- The subject has had an original diagnosis of PCa and underwent radical curative therapy at least 3 months before enrolment, and has been diagnosed with BCR on the basis of:
- •o Increase in PSA level ~2.0 ng/mL above the nadir level after radiotherapy or brachytherapy31.
- •- The patient has not had previous recurrences of PCa, i.e. this is the first diagnosis of BCR.
- •- The patient is being considered for radical salvage therapy.
- •- The patient is able and willing to comply with study procedures, and signature and dating of the ICF is obtained before any study-related procedure is performed.
- •- The patient’s ECOG performance status is
排除标准
- •Group A exclusion criteria
- •- Any prior treatment for prostate gland tumours.
- •- The patient has received, or is scheduled to receive, another investigational medicinal product (IMP) from 1 month before to 1 week after administration of 68Ga-THP-PSMA injection.
- •- The patient has known hypersensitivity to 68Ga-THP-PSMA injection or any of its constituents.
- •- The patient has been previously included in this study.
- •- Estimated glomerular filtration rate <20 mL/min per 1.73 m2 as assessed by local practices.
- •Group B and Group C exclusion criteria
- •- The patient has been previously included in this study.
- •- The patient has received, or is scheduled to receive, another IMP from 1 month before to 1 week after administration of 68Ga-THP-PSMA injection.
- •- The patient has known hypersensitivity to 68Ga-THP-PSMA injection or any of its constituents.
- •- Hormone therapy within the past 3 months.
- •- Estimated glomerular filtration rate <20 mL/min per 1.73 m2 as assessed by local practices.
研究者
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