UpFrontPSMA : A Randomised Phase 2 Study of Sequential 177Lu-PSMA617 and Docetaxel Versus Docetaxel in Metastatic Hormone-Naive Prostate Cancer
概览
- 阶段
- 2 期
- 干预措施
- 177Lu-PSMA-617
- 疾病 / 适应症
- Metastatic Hormone Naive Prostate Cancer
- 发起方
- Peter MacCallum Cancer Centre, Australia
- 入组人数
- 130
- 试验地点
- 12
- 主要终点
- Undetectable prostate specific antigen (PSA) rate at 12 months after commencement of protocol therapy
- 状态
- 进行中（未招募）
- 最后更新
- 9个月前
概览
简要总结
This phase 2 randomised clinical trial will compare the effectiveness of Lu-PSMA therapy followed by docetaxel chemotherapy versus docetaxel chemotherapy on its own in patients with newly-diagnosed high-volume metastatic hormone-naive prostate cancer (mHNPC).
详细描述
This is an open label, randomised, stratified, 2-Arm, multi-centre, phase 2 clinical trial recruiting 140 newly-diagnosed high-volume mHNPC patients at 11 Australian centres over a period of 18 months. Patients will be randomised to the experimental Arm (177Lu-PSMA followed by docetaxel) or standard-of-care Arm (docetaxel) in a 1:1 ratio. All patients will receive ADT continuously throughout the trial. Patients will be stratified according to disease volume by conventional imaging (low-volume vs. high-volume) and duration of ADT at time of registration (≤ 28 days vs. \> 28 days).
研究者
入排标准
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
177Lu-PSMA+ Docetaxel
7.5 GBq (± 10%) 177Lu-PSMA every 6 weeks x 2 cycles. Docetaxel 75 mg/m2 commencing 6 weeks later, every 3 weeks x 6 cycles
干预措施: 177Lu-PSMA-617
177Lu-PSMA+ Docetaxel
7.5 GBq (± 10%) 177Lu-PSMA every 6 weeks x 2 cycles. Docetaxel 75 mg/m2 commencing 6 weeks later, every 3 weeks x 6 cycles
干预措施: Docetaxel
Docetaxel (Control)
Docetaxel 75 mg/m2 every 3 weeks x 6 cycles
干预措施: Docetaxel
结局指标
主要结局
Undetectable prostate specific antigen (PSA) rate at 12 months after commencement of protocol therapy
时间窗: Upto 32 months assuming 18 months to complete recruitment, a maximum of 1.6 months from consent to commencement of treatment for last patient and then 12 months from commencement of treatment for last patient.
Undetectable PSA is defined as PSA ≤ 0.2ng/ml at 12 months after protocol treatment commencement. Patients who experience unequivocal radiographic (by conventional imaging modality) and/or clinical disease progression within 12 months of initiating protocol treatment will be considered as not having undetectable PSA at 12 months.
次要结局
- PSA-progression free survival (PSA-PFS) between treatment Arms(Through study completion, up until 2 years after the last patient commences treatment.)
- Radiographic-PFS (rPFS) between treatment Arms(Through study completion, up until 2 years after the last patient commences treatment.)
- Describe and compare health-related QoL within 12 months of treatment commencement between treatment Arms(Through completion of 12 months after treatment commencement of last patient, maximum 32 months.)
- Safety of 177Lu-PSMA followed by docetaxel compared to docetaxel alone(Through completion of treatment, maximum 26 months.)
- Time to development of castration resistance between treatment Arms(Through study completion, up until 2 years after the last patient commences treatment.)
- Overall survival (OS) between treatment Arms(Through study completion, up until 2 years after the last patient commences treatment.)
- Early PSMA PET response between treatment Arms(Through completion of 3 months after treatment commencement for last patient, maximum 23 months.)
- Describe and compare pain within 12 months of treatment commencement between treatment Arms(Through completion of 12 months after treatment commencement of last patient, maximum 32 months.)