Phase III Multicentre Prospective Comparative Study of Detection Rate of 18F-JK-PSMA-7 and of 18F-fluorocholine in Patients With Biochemical Recurrence of Prostate Cancer After Previous Treatment With Curative Intent
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Detection rate of 18F-JK-PSMA-7 PET/CT
研究概览
简要总结
The present study in patients with Prostate cancer and biochemical failure after surgery and/or radical-postoperative Radio Therapy (RT) will evaluate if PET/CT with 18F-JK-PSMA-7 compared to PET-CT 18F-Choline is able to identify the early pattern of biochemical recurrence and/or metastatic sites, so that the patient could be better managed, with a benefit in survival.
详细描述
Investigational Product:
The investigational product in this study is 18F-JK-PSMA-7, a fluorine-18 labelled ligand binding specifically to prostate specific membrane antigen (PSMA).
The investigational product 18F-JK-PSMA-7 is a diagnostic radiopharmaceutical for use with positron emission tomography (PET).
The active substance of the diagnostic radiopharmaceutical product is 18F-JK-PSMA-7.
Fluorine (F) decays to stable oxygen (O) with a half-life of 110 minutes by emitting a positronic radiation of maximum energy of 634 keV, followed by photonic annihilation radiations of 511 keV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The blind readers of PET/CT examinations with Investigational product (18F-JK-PSMA-7) and with Comparator (18F-fluorocholine) will be blinded to any clinical data of patient.
The analysis of images obtained with IMP (18F-JK-PSMA-7) and with Comparator (18F-fluorocholine) will be performed by two independent off-site experts blinded to any patient´s clinical data, using the defined grid (Appendix I). Discrepancies between results of the two observers will be recorded by the clinical manager and a consensus reading with third expert will be organized. This reading will be used for determination of imaging performances.
Wash-out period of at least one month is ensured between reading of examinations with Investigational product (18F-JK-PSMA-7) and with Comparator (18F-Fluorocholine) for each blind reader.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of prostate malignancy
- •Patient must have had their primary PCa treated with surgery and/or radiation therapy; salvage radiation to the prostate bed or pelvis is allowed
- •Patient must be ≥ 18 years of age
- •Patient must have an Eastern Cooperative Oncology Group performance status ≤ 2
- •For patients treated with radical prostatectomy: arise of PSA ≥ 0.2 ng/mL (performed in the last month) or a rise of 2 ng/mL or more above the nadir PSA after definitive radiation therapy defined by two subsequent PSA assessments performed over a 3-month period in the same laboratory
- •Absence of any of the exclusion criteria
- •Signed informed consent
排除标准
- •Absence of any of the inclusion criteria;
- •More than 3 years of androgen deprivation therapy (ADT), with less than 3 months from the last treatment
- •Spinal cord compression or impending spinal cord compression
- •Receipt of any other investigational agents in the previous 3 months
- •Inability to lie flat during or tolerate PET/CT
- •Hypersensitivity to active substance or any of excipients of Investigational Medicinal Product or Comparator
- •Life expectancy <6 months
- •ECOG performance status >2
- •Refusal to sign informed consent
- •Participation in a concurrent clinical trial
- •Concomitant active malignancy
- •Subject deprived of its freedom by administrative or legal decision or who is under guardianship
研究组 & 干预措施
Interventional and Comparator
The subject participation in the study consists from performing of one non-contrast enhanced PET/CT with Investigational Product (18F-JK-PSMA-7) and of one PET/CT with Comparator (18F-Fluorocholine) This sequence of administration is established in advance as the organizational model, linked to the availability and management of the radiopharmaceutical, not allow to perform a randomization.
干预措施: Radiopharmaceutical 18F-JK-PSMA-7 (Drug)
Interventional and Comparator
The subject participation in the study consists from performing of one non-contrast enhanced PET/CT with Investigational Product (18F-JK-PSMA-7) and of one PET/CT with Comparator (18F-Fluorocholine) This sequence of administration is established in advance as the organizational model, linked to the availability and management of the radiopharmaceutical, not allow to perform a randomization.
干预措施: Radiopharmaceutical 18F-Fluorocholine (Drug)
结局指标
主要结局
Detection rate of 18F-JK-PSMA-7 PET/CT
时间窗: 1 Months
To evaluate the diagnostic accuracy of 18F-JK-PSMA-7 versus 18F- Fluorocholine even for low PSA levels, where the 18F- Fluorocholine is considered to be insensitive in these conditions. Hypothesis: a 20% diagnostic superiority of 18F-JK-PSMA-7 versus 18F- Fluorocholine.
次要结局
- Evaluation of the safety profile of 18F-JK-PSMA-7(6 months)
- Evaluation of specificity of 18F-JK-PSMA-7(6 months)
- Evaluation of the discordance rate between IMP and Comparator(1 month)
- Influence of 18F-JK-PSMA-7 in the therapeutic management decision(6 months)
- Evaluation of sensitivity of 18F-JK-PSMA-7(6 months)