EUCTR2020-003969-19-SE进行中（未招募）1 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 - PSMAfore
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Signed informed consent must be obtained prior to participation in the
- •2. Participants must be adults = 18 years of age
- •3. Participants must have an ECOG performance status of 0 to 1
- •4. Participants must have histological pathological, and/or cytological
- •confirmation of adenocarcinoma of the prostate
- •5. Participants must be 68Ga-PSMA-11 PET/CT scan positive, and eligible
- •as determined by the sponsor's central reader
- •6. Participants must have a castrate level of serum/plasma testosterone
- •(< 50 ng/dL or < 1.7 nmol/L)
- •7a. 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
- •8. 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 the
- •bone scan defines metastatic disease to bone (PCWG3 criteria (Scher et
- •9a. Participants must have = 1 metastatic lesion that is present on
- •screening/baseline CT, MRI, or bone scan imaging obtained = 28 days
- •prior to randomization
- •10. Participants must have recovered to = Grade 2 from all clinically
- •significant toxicities related to prior therapies (i.e. prior chemotherapy,
- •radiation, etc.) except alopecia
- •Other protocol-defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 135
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 315
排除标准
- •1. 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
- •2. Previous PSMA-targeted radioligand therapy
- •3a. 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.]
- •4. Any investigational agents within 28 days prior to day of
- •randomization
- •5. Known hypersensitivity to any of the study treatments or its
- •excipients or to drugs of similar classes
- •6a. Concurrent cytotoxic chemotherapy, immunotherapy, radioligand
- •therapy, PARP inhibitor, biological, or investigational therapy
- •7. Transfusion or use of bone marrow stimulating agents for the sole
- •purpose of making a participant eligible for study inclusion
- •8a. Participants with a history of CNS metastases who 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),
- •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.
- •9. Symptomatic cord compression, or clinical or radiologic findings
- •indicative of impending cord compression
- •10. 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
- •other protocol-defined exclusion criteria may apply
研究者
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