NCT05582876招募中不适用
Multicenter Assessment of Clinical Utility PET / MR With the Use of the Radiotracer 68Ga-PSMA-11 in Therapy Planning Personalized in Patients With Prostate Cancer
Medical University of Bialystok14 个研究点 分布在 1 个国家目标入组 366 人开始时间: 2023年1月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 366
- 试验地点
- 14
- 主要终点
- Sensivity of the radiopharmaceutical 68Ga-PSMA-11 compared to PET/MR and PET/CT
研究概览
简要总结
The aim of multicentre phase 3 trial is evidence diagnostic value of 68Ga-PSMA-11 (in PET / CT and PET / MR techniques) in patients with high-risk and intermediate prostate cancer before radical treatment and in diagnosed patients biochemical recurrence after radical treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis or high probability of medium and high prostate cancer according International Society of Urological Pathology (ISUP) risk for whom radical treatment is planned
- •Prostate adenocarcinoma confirmed by biopsy and histopathological examination
- •Results indicating a moderate RGK (Gleason score 7 or cT2b or PSA 10-20 ng / ml) or high (Gleason score> 7 or cT2c or PSA> 20 ng / ml) risk according to ISUP
- •Creatinine value allowing for safe PET / MR examination with a contrast agent: creatinine less than or equal to 1.5 times the upper limit of normal, creatinine clearance> 60 mL / min
- •Age ≥18 years
- •Signing informed consent to participate in the study
- •Pelvic / prostate mpMR examination performed, not earlier than 30 days before inclusion in the study
- •Patients with RGK after radical treatment, with biochemical recurrence according to EAU criteria, who are scheduled for further treatment and the result of the imaging / molecular examination may affect change of therapeutic decision:
- •Prostate adenocarcinoma confirmed by biopsy and histopathological examination
- •After radical treatment
- •In patients after radical prostatectomy: with at least two PSA measurements ≥0.2 ng / ml not earlier than after 6-13 weeks after radical prostatectomy or PSA≥0.1 with PSAdt (PSA doubling time) <3 months PSA on at least two consecutive studies in consecutive last 6 months before qualification (last determination within 6 weeks before qualification) Or
- •In patients after radical radiotherapy: biochemical recurrence defined as nadir PSA + 2 ng / ml
- •Age ≥18 years
- •Signing informed consent
排除标准
- •Presence of metallic foreign bodies / implants / prostheses / stimulators etc. inside the body, the possession of which is a contraindication to the MR 3T examination
- •Claustrophobia
- •Patient size precluding PET / MR examination due to diameter gantry
- •Known contraindications for the use of radiopharmaceuticals or substances auxiliary (e.g. renal failure and allergy to ingredients in the preparation)
- •Treatment for malignant neoplasm not associated with the prostate gland
- •Participating in another clinical trial
- •Lack of informed consent to participate in the study
- •Age <18 years
结局指标
主要结局
Sensivity of the radiopharmaceutical 68Ga-PSMA-11 compared to PET/MR and PET/CT
时间窗: 24 months
Validation of the diagnostic value of 68Ga-PSMA-11 (in PET / CT and PET / MR techniques) in the assessment stage of prostate cancer and precise assessment of the location of neoplastic changes.
次要结局
- Number of participants with adverse events related to 68Ga-PSMA-11(24 months)
- Establishing a therapeutic path depending on the PET/MR and PET/CT(24 months)
- Detection of the site of recurrence(24 months)
- Determination of PSA concentration(24 months)
- Evaluation of pharmacoeconomic data(24 months)
- Absorbed radiation dose(24 months)
研究者
研究点 (14)
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