NCT05902247招募中1 期
Phase I Dose Escalation Study to Evaluate Tolerability and Safety of 225Ac-PSMA I&T in Patients With Metastatic Prostate Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Absolute values and changes from baseline in laboratory parameters (hematology, blood chemistry and urinalysis), including assessment of shifts from baseline to abnormal values on treatment
研究概览
简要总结
225Ac-PSMA I&T is a radiopharmaceutical for therapy of prostate cancer. PSMA is overexpressed on prostate cancer cells. Actium-225 is an alpha emitting radionuclide. When PSMA I&T is labelled with Actium-225, it can be applied as therapy for prostate cancer.
详细描述
Rationale:
225Ac-PSMA I&T is a radiopharmaceutical for therapy of prostate cancer. PSMA is overexpressed on prostate cancer cells. Actium-225 is an alpha emitting radionuclide. When PSMA I&T is labelled with Actium-225, it can be applied as therapy for prostate cancer.
Objective:
To evaluate the tolerability and safety of 225Ac-PSMA I&T in patients with metastatic prostate cancer and recommend a dose for further phase 2 studies.
Study design:
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
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
- •Histopathological proven metastatic castration resistant prostate cancer. Castrationresistant disease is defined as a serum testosterone level of 50 nanogram per deciliter or lower (≤1.7 nanomol per liter) after bilateral orchiectomy or during maintenance treatment consisting of androgen-ablation therapy with a luteinizing hormone-releasing hormone agonist.
- •Evidence of progressive disease, defined as 1 or more Prostate Cancer Work Grouping 3 (PCWG3) criteria: - PSA level ≥ 1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart
- •Progression as defined by RECIST 1.1 with PCGW3 modifications
- •Progression after at least one line of chemotherapy and/or one line of nonsteroidal antiandrogen (NSAA).
- •No active anti-tumor therapy, except for androgen deprivation therapy in combination with at least one androgen receptor-targeted agent
- •Willing and able to undergo 2 cycles of 225Ac-PSMA I&T therapy and 3 PET-MRI scans in 16 weeks and comply with protocol
- •Signed and dated written informed consent by the patient (or legal representative) prior to any study-specific procedures.
- •Age ≥ 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance-status score 0-
- •Use of highly effective methods of contraception (female partners of male participants)
- •During the trial and 6 months after completion of the study or willing to practice sexual abstinence.
排除标准
- •Concurrent severe illness or clinically relevant trauma within 2 weeks before the administration of the investigational product that might preclude study completion or interfere with study results
- •Serum hemoglobin ≤ 6.2 mmol/L, total white blood cell (WBC) count ≤ 3.5·109/L, absolute neutrophil count ≤ 1.5·109/L, platelet count ≤ 100·109/L, serum creatinine concentration ≥ 150 umol/L (≥ 1.7 mg/dL), serum albumin <30 g/L, bilirubin ≥ 1.5 x upper limit normal (ULN), aspartate transaminase (ASAT) ≥ 3 x ULN and alanine aminotransferase (ALAT) ≥ 3 x ULN (or bilirubin ≥ 3 x ULN, ASAT ≥ 5 x ULN and ALAT ≥ 5 x ULN in the case of pre-existing liver metastases at baseline)
- •Concurrent bladder outflow obstruction or unmanageable urinary incontinence
- •Known or expected hypersensitivity to Gallium-68, Actinium-225, PSMA I&T, or any excipient present in 225Ac/68Ga-PSMA I&T
- •Prior administration of a radiopharmaceutical within a period corresponding to 8 halflives of the radionuclide used on such radiopharmaceutical
- •Prior treatment with any radionuclide therapy
- •History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
- •Central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
- •Radiation therapy within 4 weeks of first dose (or local or focal radiotherapy within 2 weeks of first dose)
- •Male subjects unwilling to abstain from donating sperm during treatment and for an additional 6 months after the last dose
结局指标
主要结局
Absolute values and changes from baseline in laboratory parameters (hematology, blood chemistry and urinalysis), including assessment of shifts from baseline to abnormal values on treatment
时间窗: 4 years
Safety and tolerability assessment
Absolute values and changes from baseline in vital signs & ECG parameters
时间窗: 4 years
Safety and tolerability assessment
Incidence and severity of Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0
时间窗: 4 years
Safety and tolerability assessment
次要结局
- Percent changes from baseline in tumor size where tumor size is defined as the sum of all target lesions as measured by RECIST criteria v.1.1.(4 years)
- Prostate Specific Antigen(PSA) response rate assessed from treatment visit 1 defined as a decrease in PSA of ≥ 50% from baseline.(4 years)
- To predict and calculate the absorbed-dose in critical organs (e.g. salivary glands, kidneys, bone marrow) by 68Ga-PSMA I&T PET-MRI(4 years)
- Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria v.1.1.(4 years)
- Changes in SUVmax of the target lesions on PET-MRI and morphological changes evaluated on MRI(4 years)
- Percent change from baseline in PSA as a continuous endpoint by visit and maximum reduction during the study(4 years)
- Percent change from baseline values of pain questionnaire at every treatment visit(4 years)
- Overall Survival (OS) defined as the time from the date of first dose of 225Ac-PSMA I&T treatment to the date of death due to any cause.(4 years)
研究者
Tessa Brabander
Principal Investigator
Erasmus Medical Center
研究点 (2)
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