Treating 前列腺癌 That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging

关于

简短的总结

这个III期试验通过两个单独的治疗比较来检验两个问题. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen [PSA] after surgical removal of the prostate cancer).

A second question tests treatment in patients with biochemical recurrence who show prostate cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET) imaging. 在这些病人中, the benefit of adding metastasis-directed radiation to enhanced therapy (apalutamide in combination with abiraterone + prednisone) is tested.

诊断程序，如PET，可以帮助医生寻找已经扩散到骨盆的癌症. 雄激素是一种可能导致前列腺癌细胞生长的激素. 阿帕鲁胺可能通过阻止肿瘤细胞使用雄激素来帮助对抗前列腺癌. Metastasis-directed targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. 这项试验可以帮助医生确定是否使用PET结果来提供更有针对性的治疗.e., 添加apalutamide, 有或没有靶向放射治疗, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.

主要目的

治疗

研究类型

介入

阶段

第三阶段

资格

性别

男性

健康的志愿者

No

最低年龄

18年

最高年龄

N/A

入选标准:

步骤0:注册资格标准
Patient must be male and >= 18 years of age.
Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma
RP术后患者必须有生化复发(BCR)，定义如下:
- 是时候进行BCR了, defined as time to first detectable PSA ( > lower limit of normal for assay used) after RP, is < 12 months, a minimum PSA level of >= 0.2 ng/mL and a confirmatory reading of >= 0.2 ng/mL, per the American Urological Association (AUA) definition (Note: patients with a persistent PSA reading of at least 0.2 ng/mL合格)
- 是时候进行BCR了, defined as time to first detectable PSA (> lower limit of normal for assay used) after RP, is >= 12 months, 最小绝对PSA为0.5 ng/mL是必需的
- If the patient has a detectable PSA (> lower limit of normal for assay used) at any time after RP AND has an eligible baseline SOC PET (PET1) with at least one positive lesion in any location, 那么就没有最低PSA要求了
Patients must have no definite evidence for extrapelvic metastatic disease by conventional imaging modalities (CIM) (CT abdomen/pelvis or MRI abdomen/pelvis AND bone scintigraphy, 或同等学历), 在步骤0注册前26周内. 如果患者只有符合研究条件的PET/CT或PET/MR (i.e., 在未进行CIM的情况下进行PET检查:如果PET对盆腔外病变呈阴性, 那么基线CIM就不需要了. 如果PET阳性为盆腔外病变, then patient should have a baseline CT/MRI for soft tissue lesions and/or a bone scan for osseous lesions
- Study eligible = PET using FDA-approved radiotracer and performed within 16 weeks prior to study registration
盆腔外转移被定义为任何骨转移和/或任何盆腔外软组织, lymph nodes and organ metastases; extra-pelvic is defined as superior to common iliac bifurcation, 标准前列腺床外+全骨盆淋巴结放射野. Baseline PET/CT or PET/MR scan (PET1) is eligible for this study if the SOC PET scan is completed with an FDA approved radiotracer for prostate cancer after Step 0 registration and prior to Step 1 randomization OR up to 16 weeks prior to Step 0 registration
Patient must be a candidate for SOC post-prostatectomy radiation therapy (RT) to the prostate bed and pelvic nodes with androgen deprivation therapy (ADT)
Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
患者必须具有东部肿瘤合作组织(ECOG)绩效状态0-2
在基线PET (PET1)成像之前，患者必须没有开始ADT的生化复发. 短疗程低剂量抗雄激素，如比卡鲁胺, 在基线研究PET/CT之后，但在研究注册之前给予, 允许作为启动协议批准的SOC ADT之前的短暂临时措施.
患者不得参加其他治疗性临床试验
Patient must be able to lie flat and still for approximately 20-30 minutes or otherwise tolerate a PET scan and radiation treatment planning and delivery
接受PET/MR检查的患者必须符合当地机构的MRI安全指南
患者不得有癫痫发作史或已知可能导致癫痫发作的疾病.g.(如中风或头部外伤导致意识丧失)在登记前一年内
Patient must not have history of inflammatory bowel disease or any gastrointestinal disorder affecting absorption that is expected to increase risk of complication from radiotherapy
Hemoglobin (Hgb) >= 9.0 g/dL (independent of transfusion and/or growth factors within 3 months prior to Step 0 registration) (obtained within 8 weeks prior to Step 0 registration)
Leukocytes >= 3,000/mcL (obtained within 8 weeks prior to Step 0 registration)
Absolute neutrophil count >= 1,500/mcL (obtained within 8 weeks prior to Step 0 registration)
Platelets >= 100,000/mcL (obtained within 8 weeks prior to Step 0 registration)
Total bilirubin < 1.5倍的机构上限正常(ULN)(吉尔伯特综合征患者), if total bilirubin is > 1.5 x ULN, must have a direct bilirubin of < 1.5个符合资格的ULN)(在第0步注册前8周内获得)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5个机构ULN(在第0步注册前8周内获得)
Creatine < 1.5 x instituional ULN (or measured creatinine clearance > 30 mL/min)
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
已知有心脏病史或目前有心脏疾病症状的患者, 或者心脏毒性药物的治疗史, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. 才有资格参加这次试验, 患者应为I类或II类(根据患者症状)或A类或B类(根据客观评估)
由于任何原因，患者必须没有完成盆腔放射治疗
病人必须同意在学习期间不做父亲
患者必须会说英语或西班牙语，才有资格参加研究的生活质量部分
- 注意:网站不能翻译相关的QOL表格
步骤1:随机化资格标准
Patient must have completed a baseline SOC PET/CT or PET/MR (PET1 scan) using FDA approved radiotracer with results of extra-pelvic metastases involvement known (positive or negative). The PET1 must have been completed after Step 0 registration and prior to Step 1 randomization OR up to 12 weeks prior to Step 0 registration
对于盆腔外转移阴性的患者, 必须知道盆腔内淋巴结的pet成像状态(阳性或阴性)。
For patients with positive extra-pelvic metastases (defined as any PET positive lesions outside of standard salvage RT fields [prostate bed +/- typical whole pelvis]), the number of extra-pelvic lesions must be known (1 - 5 or > 5 extra-pelvic lesions)