CTRI/2025/11/097691招募中3 期
A phase III, open-label, multi-center, randomized study comparing AAA817+ARPI versus standard of care in adult participants with PSMA-positive metastatic castration resistant prostate cancer
Novartis Healthcare Pvt Ltd3 个研究点 分布在 1 个国家目标入组 605 人开始时间: 2025年12月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 605
- 试验地点
- 3
- 主要终点
- Radiographic Progression Free Survival (rPFS)
研究概览
简要总结
The purpose of this study is to determine whether [225Ac]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator’s choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •Participants must have an ECOG performance status of 0 to
- •Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate.
- •Participants with mixed histology (neuroendocrine) are not eligible.
- •Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).
- •Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol and are eligible as determined by the sponsor’s central reading rules.
- •Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI), based on at least 1 of the following criteria: Serum/plasma PSA progression is defined as 2 increases in PSA measured at least 1 week apart.
- •The minimal start value is 2.0 ng/mL; 1.0 ng/mL is the minimal starting value if confirmed rise in PSA is the only indication of progression as per PCWG3 guidelines.
- •• Soft-tissue progression defined [PCWG3-modified RECIST v1.1 (Eisenhauer et al 2009, Scher et al 2016)].
- •Progression of bone disease: 2 new lesions; only positivity on the bone scan defines metastatic disease to bone (PCWG3 criteria Scher et al 2016).
排除标准
- •Previous treatment with any approved or investigational RLT, approved or investigational radioisotopes Previous treatment with any conventional external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases).
- •Participants with known or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer.
- •Any approved or investigational agents/systemic anti-cancer therapy (e.g. other chemotherapy, investigational therapy, immunotherapy or biological therapy including monoclonal antibodies) within 28 days (or 5 times the half-life of that therapy whichever is longer) of the anticipated day C1D
- •Diagnosed with other active malignancies that are expected to alter life expectancy or may interfere with disease assessment.
结局指标
主要结局
Radiographic Progression Free Survival (rPFS)
时间窗: From the date of randomization to the date of the first documented radiographic disease progression using conventional imaging, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
次要结局
- Overall Survival (OS) (Key Secondary Endpoint)(From the date of randomization to the date of death due to any cause, assessed up to approximately 40 months.)
- Radiographic Progression Free Survival by PSMA PET/CT and (rPSF-PET)(Key Secondary)(From date of randomization to the date of the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.)
- Progression Free Survival (PFS2)(From date of randomization until date of second progression or date of death from any cause, whichever comes first, assessed up to approximately 40.0 months.)
- Overall Response Rate (ORR)(From the date of randomization to the date of the first documented radiographic disease progression, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.)
- Disease Control Rate (DCR)(From the date of randomization to the date of the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.)
- Time to first radiographic soft tissue progression (TTSTP)(From the date of randomization to the date of radiographic soft tissue progression or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.)
- Time to first symptomatic skeletal event (TTSSE)(From the date of randomization to the date of the first documented radiographic disease progression, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.)
- Prostate specific antigen response (PSA50 and PSA90)(From the date of randomization to the date of safety follow up, assessed up to approximately 40.0 months.)
- Time-concentration profiles and PK parameters of AAA817(From Cycle 1 Day 1 up to approximately cycle 5 days 11 (each cycle is 8 weeks).)
- Change from baseline on FACT-P Prostate Cancer Subscale (PCS)(From randomization to the first occurrence of worsening on the score or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.)
- Time to worsening on the Worst Pain(From randomization to the first occurrence of worsening from baseline, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.)
- rPFS in participants treated with AAA817(From the date of randomization to the date of the first documented radiographic disease progression, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.)
- OS in participants treated with AAA817(From the date of randomization to the date of death due to any cause assessed up to approximately 40.0 months.)
研究者
Murugananthan K
Novartis Healthcare Private Limited
研究点 (3)
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