NL-OMON52179招募中3 期
PSMAfore: A phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of androgen receptor-directed therapy in the Treatment of Taxane Naïve Men with Progressive Metastatic Castrate Resistant Prostate Cancer - CAAA617B12302
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- ovartis
- 入组人数
- 25
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
- 18 至 99（—）
入选标准
- •Participants must have an ECOG performance status of 0 to 1
- •Participants must have histological pathological, and/or cytological
- •confirmation of adenocarcinoma of the prostate
- •Participants must be 68Ga-PSMA-11 PET/CT scan positive, and eligible as
- •determined by the sponsor*s central reader
- •Participants must have a castrate level of serum/plasma testosterone (< 50
- •ng/dL or < 1.7 nmol/L)
- •Participants must have progressed only once on prior second generation ARDT
- •(abiraterone, enzalutamide, darolutamide, or apalutamide).
- •first generation androgen receptor inhibitor therapy (e.g. bicalutamide) is
- •allowed but not considered as prior ARDT therapy
- •second generation ARDT must be themost recent therapy received
- •Participants must have progressive mCRPC. Documented progressive mCRPC will
- •be based on at least 1 of the following criteria:
- •Serum/plasma PSA progression 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
- •Soft-tissue progression defined [PCWG3-modified RECIST v1.1 (Eisenhauer et al
- •2009, Scher et al 2016)]
- •Progression of bone disease: two new lesions; only positivity on thebone scan
- •metastatic disease to bone (PCWG3 criteria (Scher et al 2016))
- •Participants must have >= 1 metastatic lesion that is present on
- •screening/baseline CT, MRI, or bone scan imaging obtained <= 28 days prior to
- •beginning study therapy
- •Participants must have recovered to <= Grade 2 from all clinically significant
- •toxicities related to prior therapies (i.e. prior chemotherapy, radiation,
- •etc.) except alopecia
- •Participants must have adequate organ function
排除标准
- •- Previous treatment with any of the following within 6 months of
- •randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-
- •188, Radium-223, hemi-body irradiation
- •- Previous PSMA-targeted radioligand therapy
- •- Prior treatment with cytotoxic chemotherapy for castration resistant
- •or castrate sensitive prostate cancer (e.g., taxanes, platinum,
- •estramustine, vincristine, methotrexate, etc.), immunotherapy or
- •biological therapy [including monoclonal antibodies]) [Note: Taxane
- •exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is
- •allowed if 12 months have elapsed since completion of this adjuvant or
- •neoadjuvant therapy]. Prior treatment with sipuleucel-T is allowed
- •- Any investigational agents within 28 days prior to day of
- •randomization
- •- Known hypersensitivity to any of the study treatments or its
- •excipients or to drugs of similar classes
- •- Other concurrent cytotoxic chemotherapy, immunotherapy,
- •radioligand therapy, PARP inhibitor, biologicals or investigational therapy
- •- Transfusion or use of bone marrow stimulating agents for the sole
- •purpose of making a participant eligible for study inclusion
- •- Patients with a history of CNS metastases that are neurologically
- •unstable, symptomatic, or receiving corticosteroids for the purpose of
- •maintaining neurologic integrity. Participants with CNS metastases are
- •eligible if received therapy (surgery, radiotherapy, gamma knife),
- •XML File Identifier: TAvYk8QpGNNGCZNzW8LbncoFA8o=
- •asymptomatic and neurologically stable without corticosteroids.
- •Participants with epidural disease, canal disease and prior cord
- •involvement are eligible if those areas have been treated, are stable, and
- •not neurologically impaired.
- •- Symptomatic cord compression, or clinical or radiologic findings
- •indicative of impending cord compression
- •- History or current diagnosis of the following ECG abnormalities
- •indicating significant risk of safety for study participants:
- •- Concomitant clinically significant cardiac arrhythmias, e.g. sustained
- •ventricular tachycardia, complete left bundle branch block, high-grade
- •AV block (e.g., bifascicular block, Mobitz type II and third degree AV
- •- History of familial long QT syndrome or known family history of
- •Torsades de Pointe
- •- Cardiac or cardiac repolarization abnormality, including any of the
- •following: History of myocardial infarction (MI), angina pectoris, or
- •CABG within 6 months prior to starting study treatment
研究者
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