EUCTR2016-000842-79-BE进行中（未招募）1 期
Prospective evaluation of 68Ga-PSMA PET-CT for Recurrence detection of Prostate Cancer and its impact on patient management The ProsPERo Trial - PROSPERO
Institut Jules Bordet0 个研究点目标入组 75 人开始时间: 2016年7月4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
- 75
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
- •Age = 18 years old.
- •Histologically-proven prostate adenocarcinoma.
- •Biochemical recurrence after initial treatment with radical curative intent based on PSA values 1:
- •a) Following Radical Prostatectomy (RP) +/- Radiotherapy (RT): a serum PSA increase confirmed by a second PSA measurement higher than the first one with a value of 0.2 ng/mL or more within minimum of one week.
- •b) Following primary RT: PSA value of 2 ng/ml above the nadir.
- •c) A continued rise in PSA level despite treatment with curative intent.
- •Patients with negative, inconclusive or oligometastatic disease on the RIW and susceptible to be treated with curative radical intent (salvage treatment).
- •RIW exams are accepted when performed within 1 month before PSMA-PET/CT (this includes WB-MRI, prostatic/pelvic MRI, and/or Bone Scintigraphy).
- •Patient treatment strategy based on routine diagnostic work-up needs to be recorded after discussion at the UTB and available before the PSMA-PET/CT.
- •ECOG performance status = 2.
- •Signed informed consent prior to any study related procedure.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •Previous malignancy other than PCa (except basocellular or squamous cell skin cancer).
- •Patients previously treated with palliative chemotherapy or new hormonal therapies like Abiraterone/Enzalutamide.
- •PSA rise while on active treatment (LHRH-agonist, LHRH-antagonist, anti-androgen, maximal androgen blockade, oestrogen). A minimal time window of 1 month is required.
- •Medical castration with Testosterone < 50 ng/dl (1.7 nmol/L).
- •Previous treatment with isotopes (Radium, Samarium, Strontium, etc.)
- •All medical conditions that might interfere with the correct performance of imaging scans.
- •Known allergy/sensitivity to 68Ga or HBED-CC coupled substance, or any of the ingredient(s) or excipient(s) of the study medication(s)
研究者
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