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临床试验/NCT03490032
NCT03490032已完成1 期

A Phase 1/2 Open-label, Multi-center, Safety and Tolerability Study of a Single Dose of 68Ga-PSMA-R2 in Patients With Biochemical Relapse (BR) and Metastatic Prostate Cancer (mPCa)

Advanced Accelerator Applications5 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年5月23日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
30
试验地点
5
主要终点
Number of Participants With Treatment Emergent Adverse Events
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This was an open-label, multicenter, single dose, Phase I/II study to evaluate the safety and tolerability of a single administration of 3 mega Becquerel (MBq)/kg, but not less than 150 MBq and not more than 250 MBq, of 68^Ga-PSMA-R2 in adult male patients with biochemical relapse (BR) and metastatic prostate cancer (mPCa).

详细描述

This study consisted of 2 parts.

  • During the first part (Phase I) of the study, 6 subjects with biochemically recurrent prostate cancer (PCa) received the investigational product (IP) and remained at the site for approximately 6 hours post-administration in order to assess the PK, biodistribution versus time, and dosimetry for critical organs. Subjects received a single dose of 3 MBq/kg, (>=150 and =<250 MBq), of 68^Ga-PSMA-R2 intravenously. Serial blood and urine samples were collected for PK characterization and dosimetry and whole-body PET/CT were acquired at selected time points (0 to 4 hours) to determine organ and tumor absorbed doses. Safety assessments were conducted after IP administration on Day 1, and during follow-up on Days 7 and 28.
  • In the second part of the study (Phase II), 2 groups of 12 subjects were enrolled (subjects with PCa in biochemical recurrence [PCa-BR], and subjects with prostate cancer in the metastatic stage [mPCa]). Based on the preliminary data analysis from the Phase I part of the study provided sufficient dosimetry data, all subjects underwent the whole body PET/CT imaging optimized for time (up to 2 time points) according to the data analysis from the Phase I part of the study.

This study was comprised of 4 clinical visits and conducted in 3 study periods: screening, administration/imaging, and safety follow-up period.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Diagnostic
盲法
None

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

  • •Males 18 years or older.
  • •Signed and dated written informed consent by the subject prior to any study-specific procedures.
  • •Histologically confirmed adenocarcinoma of the prostate, defined as follows:
  • •Biochemical recurrence: defined as PSA is ≥0.2 ng/mL after radical prostatectomy or PSA nadir plus 2 ng/mL after radiation therapy with corresponding CT/MRI or bone scan revealing absence of local recurrence or metastatic lesions.
  • •Metastatic disease: defined as both, castration-sensitive or castration-resistant mPCa (presence of at least 1 metastatic lymph node, visceral metastasis and/or bone metastasis).
  • •At least 2 weeks must have elapsed between last anticancer treatment administration and the administration of the imaging product, 68Ga-PSMA-R
  • •Prior major surgery must be at least 12 weeks prior to study entry.
  • •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2, with a life expectancy ≥6 months.
  • •Adequate bone marrow reserve and organ function as demonstrated by complete blood count, and biochemistry in blood and urine at Screening:
  • •Hemoglobin (Hb): >8 g/dL
  • •Platelet count of >50.000/mm3
  • •Serum creatinine <1.5*upper limit normal (ULN) or estimated glomerular filtration rate (eGFR) >50 mL/min based upon The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
  • •For male subjects with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 28 days after IP administration.

排除标准

  • •Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate or any other histologies different than adenocarcinoma.
  • •Administered a radioisotope =<10 physical half-lives prior to the day of PET/CT.
  • •Current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, or need of indwelling/condom catheters.
  • •Uncontrolled pain or incompatibility that results in subject's lack of compliance with imaging procedures.
  • •Other known coexisting malignancies except non-melanoma skin or low grade superficial bladder cancer unless definitively treated and proven no evidence of recurrence for 5 years.
  • •Subject with known incompatibility to CT scans.
  • •Any evidence of severe or uncontrolled systemic or psychiatric diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the protocol, or active infection including human immunodeficiency virus (HIV) and untreated hepatitis B, hepatitis C. Screening for chronic conditions was not required.
  • •Subjects who have received any investigational agent within the last 28 days were excluded from participation in this study.
  • •Any acute toxicity due to prior chemotherapy and/or radiotherapy that has not resolved according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Studies.
  • •Known allergy, hypersensitivity, or intolerance to the IP or its excipients.
  • •Subject unlikely to comply with study procedures, restrictions and requirements and judged by the investigator to be unsuitable for study participation.

研究组 & 干预措施

Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)

Experimental

All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq].

干预措施: [68Ga]-PSMA-R2 (Drug)

Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)

Experimental

All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq].

干预措施: [68Ga]-PSMA-R2 (Drug)

Metastatic Prostate Cancer (mPCa) (Phase II)

Experimental

All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq].

干预措施: [68Ga]-PSMA-R2 (Drug)

结局指标

主要结局

Number of Participants With Treatment Emergent Adverse Events

时间窗: dosing through 28 days post-dose

Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.

次要结局

  • Phase I: Effective Dose of 68Ga-PSMA-R2(68Ga-PSMA-R2 PET imaging acquired at Day 1)
  • Phase I: Urinary Excretion of [68Ga]-PSMA-R2(0 to 6 hours post-dose)
  • Phase I: Half-life of 68Ga-PSMA-R2 in Blood(0 to 6 hours post-dose)
  • Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs(68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection))
  • Phase I: Residence Times in Normal Organs(68Ga-PSMA-R2 PET imaging acquired at Day 1)
  • Phase I: Absorbed Dose of 68Ga-PSMA-R2(68Ga-PSMA-R2 PET imaging acquired at Day 1)
  • Phase I: Whole-body Dose of 68Ga-PSMA-R2(68Ga-PSMA-R2 PET imaging acquired at Day 1)
  • Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint(68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection))
  • Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans by Timepoint(68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection))
  • Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint(68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection))
  • Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint(68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection))
  • Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint(68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection))
  • Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs(68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection))
  • Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint(68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection))
  • Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients(68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection))
  • Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)(68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour post-injection))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (5)

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