JPRN-jRCT2031230608尚未招募3 期
An International, Prospective, Open-label, Multi-center, Randomized Phase III Study comparing lutetium (177Lu) vipivotide tetraxetan (AAA617) versus observation to delay castration or disease recurrence in adult male patients with prostate-specific membrane antigen (PSMA) positive Oligometastatic Prostate Cancer (OMPC).
Yamauchi Kyosuke0 个研究点目标入组 20 人开始时间: 2024年1月31日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- Male
入选标准
- •1.Histologically confirmed prostate cancer prior to randomization
- •2.Participants must have biochemically recurrent disease after definitive treatment to prostate by Radical Prostatectomy ((RP), (alone or with post-operative radiation to prostate bed/pelvic nodes)) or External beam Radiation Therapy (XRT), (prostate alone or prostate with seminal vesicle and/or pelvic nodes) and/or brachytherapy prior to randomization.
- •3.Participants must have OMPC with =<5 PSMA-positive metastatic lesions on screening PSMA PET/CT scan (with either gallium (68Ga) gozetotide or piflufolastat (18F)) as visually assessed by BIRC based on the methodology proposed in the Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE v2).
- •4.At least 1 PSMA-positive lesion should be a distant metastasis (M1) per AJCC8 classification at screening. For AJCC M staging, PSMA PET information should be used
- •5.Participants must have a negative conventional imaging for M1 disease at screening
- •6.All metastatic lesions detected at screening should be amenable to SBRT.
- •7.Non-castration testosterone level >100 ng/dL at screening.
排除标准
- •1.Participants with de novo OMPC at screening
- •2.Unmanageable concurrent bladder outflow obstruction or urinary incontinence at screening.
- •3.Prior therapy with:
- •a.ADT including bilateral orchiectomy
- •b.Other hormonal therapy.
- •c.Radiopharmaceutical agents
- •d.Immunotherapy
- •e.Chemotherapy
- •f.Any other investigational or systemic agents for metastatic disease
- •4.Radiation therapy external beam radiation therapy (EBRT) and brachytherapy within 28 days before randomization
- •5.Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, hormonal therapy (see ADT initiation guidance in Section 6.8.2), Poly Adenosine Diphosphate-Ribose Polymerase (PARP) inhibitor, biological therapy or investigational therapy
- •6.Diagnosed at screening with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease/treatment free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer and superficial bladder cancer.
- •7.History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants participating in the study such as:
- •- Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second or third degree Atrioventricular (AV) block without a pacemaker
- •- History of familial long QT syndrome or known family history of Torsades de Pointe
- •8.Participants in immediate need of ADT as assessed by the investigator.
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