EUCTR2020-003969-19-BE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
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
入排标准
- 性别
- Male
入选标准
- •1. Signed informed consent must be obtained prior to participation in the study
- •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 al 2016))
- •9a. 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
- •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. Other 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 block)
- •- 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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