[177Lu]Lu-PSMAI&T Radioligand Therapy (PSMA-RLT) for Patients With Prostate Cancer and Biochemical But Not Radio-morphological Local Recurrence After Primary Therapy With Curative Intent: A Prospective Phase II Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Emergence of therapy toxicity
研究概览
简要总结
Prospective single-center one-arm phase II study in patients with prostate cancer and confirmed biochemical recurrence (BCR) with PSA of ≥ 0.2 ng/ml after radical prostatectomy (RP) or PSA > nadir + 2ng/ml after radiotherapy (RT) but not radio-morphological local recurrence after primary therapy with curative intent receive systemic therapy with only 2 cycles of highly standardized (3 GBq in first cycle and 6 GBq in the second cycle) PSMA-RLT at 6-week intervals.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with biochemical recurrence after radical prostatectomy and radiotherapy with a PSA doubling-time (DT) of ≤ 12 months.
- •No hormonal therapy within the last 12 months or recovered testosterone levels.
- •PSMA PET negative result for local recurrence; presence of distant metastases is allowed: (cN0, cM0/cM1).
- •Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- •Patients must have adequate bone marrow reserve: WBC ≥1.5 x 109 /L, Platelets ≥100 x 109 /L and Haemoglobin ≥9 g/dL.
- •Patients must have adequate renal function with eGFR ≥ 50mL/min/1.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of ≥2.5 g/dL.
- •Patients must be able to sign Informed Consent Form.
排除标准
- •Concomitant participation in any other interventional trial.
- •Concurrent severe oncological and medical conditions that result in patients not having a life expectancy of longer than one year.
- •Presence of clinically relevant somatic or psychiatric diseases that might interfere with the objectives and assessments of the study.
- •Complete urinary out-flow obstruction or severe unmanageable urinary incontinence.
研究组 & 干预措施
Biochemical recurrent prostate cancer but not radio-morphological local recurrence
Patients with prostate cancer and confirmed biochemical recurrence with PSA of ≥ 0.2 ng/ml after radical prostatectomy or PSA > nadir + 2ng/ml after radiotherapy but not radio-morphological local recurrence after primary therapy with curative intent will receive systemic therapy with [177Lu]Lu-PSMAI&T radioligand therapy
干预措施: [177Lu]Lu-PSMA I&T (Drug)
结局指标
主要结局
Emergence of therapy toxicity
时间窗: 12 months
in terms of pathological (Grade 3) reduction of values of blood count (hemoglobin decreased \<8.0 g/dL; \<4.9 mmol/L; \<80 g/L; platelet count decreased \<50,000 - 25,000/mm3; \<50.0 - 25.0 x 10e9 /L and white blood cell decreased \<2000 - 1000/mm3; \<2.0 - 1.0 x 10e9 /L. ), kidney (creatinine increased \> 3.0 x baseline or \>3.0 - 6.0 x upper limit of normal (UNL)) and liver functions (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and GGT increased \>5.0 - 20.0 x ULN if baseline was normal or \>5.0 - 20.0 x baseline if baseline was abnormal; albumin \<2 g/dL or \<20 g/L; bilirubin increased \>3.0 - 10.0 x ULN if baseline was normal or \>3.0 - 10.0 x baseline if baseline was abnormal and lactate dehydrogenase increased \> ULN.), assessed by Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
PSA response
时间窗: 12 months
in term of PSA decline of ≥ 50% from baseline value
次要结局
- Time to PSA value progression(18 months)
- androgen deprivation therapy- and other treatment-free survival(18 months)
- Evaluation of life quality of the treated patients(18 months)
- Assess time to imaging progression(18 months)
- Quantification of circulating free tumor DNA(18 months)
研究者
Sazan Rasul, MD, PhD
Physician and post-doctoral researcher
Medical University of Vienna