NL-OMON54758招募中3 期
Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC) - DORA trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 250
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
- •Inclusion Criteria:
- •Willing and able to provide, or have a legally authorized representative
- •provide, written informed consent (ICF) and HIPAA authorization for the release
- •of personal health information. A signed informed consent must be obtained
- •before screening procedures are performed.
- •Males 18 years of age and above
- •Histological or cytological proof of prostate cancer
- •Documented progressive mCRPC based on at least one of the following criteria:
- •1. PSA progression defined as a minimum of 2 rising PSA levels with a minimum
- •of a 1 week interval between each determination. A minimum PSA of 1.0 ng/m is
- •required for study entry.
- •2. Soft-tissue progression defined as an increase >= 20% in the sum of the LD of
- •all target lesions based on the smallest sum LD since treatment started or the
- •appearance of one or more new lesions.
- •3. Progression of bone disease (evaluable disease) or two or more new bone
- •lesions by bone scan.
- •Two or more bone lesions defined by nuclear bone scan
- •ECOG 0- 1
- •Normal organ function with acceptable initial laboratory values within 14
- •days of randomization
- •Subjects must agree to use a medically acceptable method of birth control or
- •sexual abstinence for the duration of the study, including 6 months after the
- •last dose of study drug. Sperm donation is prohibited during the study and for
- •6 months after the last dose of study drug. Female partners must use hormonal
- •or barrier contraception unless postmenopausal or abstinent.
- •Serum testosterone < 50 ng/dL. Subjects must continue primary androgen
- •deprivation with an LHRH analogue (agonist or antagonist) if they have not
- •undergone orchiectomy.
- •All acute toxic effects of any prior treatment have resolved to NCI-CTCAE
- •v4.0 Grade 1 or less.
- •Willing and able to comply with the protocol, including follow-up visits and
- •examinations.
排除标准
- •Exclusion Criteria:
- •Received any other investigational therapeutic agents or other anticancer
- •therapies within 2 weeks or 5 half-lives, whichever is shorter, prior to
- •randomization.
- •Received external beam radiotherapy within the 2 weeks prior to randomization.
- •Has an immediate need for external beam radiotherapy.
- •Has received any other systemic investigational or anti-cancer
- •radiopharmaceutical in the past.
- •Has received any prostate cancer directed chemotherapy in the castration
- •resistant setting
- •Has received > 6 prior doses of docetaxel in the castration sensitive
- •setting. Subjects who have received up to 6 prior doses of docetaxel in the
- •castration sensitive setting are permitted if they have not experienced disease
- •progression within 36 weeks of last treatment with docetaxel.
- •Has received four or more systemic anticancer regimens for mCRPC.
- •o Treatment with docetaxel or abiraterone for non-castrate metastatic disease
- •is permissible and does not count towards the lines of therapy for mCRPC
- •o A 'line' is a regimen. Combinations of hormones and other types of therapies
- •count as single lines.
- •Has known Grade >=3 non-hematological docetaxel-related toxicities or
- •docetaxel toxicity related dose interruption or discontinuation.
- •Has received blood transfusions or growth factors within the last 4 weeks
- •prior to randomization.
- •Symptomatic nodal disease (i.e., scrotal, penile, or leg edema).
- •Has visceral metastases with > 3 lung and/or liver metastases or individual
- •lesion >2 cm, as assessed by CT scan or MRI of the chest/abdomen/pelvis within
- •the last 8 weeks prior to randomization.
- •Symptomatic loco-regional disease that causes ongoing Grade 3 or Grade 4
- •urinary or rectal symptoms.
- •Subjects with a second malignancy with a risk of recurrence >30% within the
- •next 3 years. Non-melanoma skin cancers, non-invasive bladder cancers and other
- •in-situ or non-invasive malignancies are permitted while on study.
- •Has imminent or established cord compression based on clinical findings
- •and/or MRI.
- •Known bone marrow dysplasia
- •Has received any of the following in the 4 weeks prior to randomization:
- •5-alpha-reductase inhibitors, natural hormonally active foods (e.g.,
- •phytoestrogens) or other food supplements known to alter PSA in humans.
- •Is receiving ongoing treatment with herbal medications that are known
- •in humans to alter PSA or the natural history of prostate cancer. Subjects
- •must discontinue any such herbal medications prior to the first dose of study
- •Any other serious illness or medical condition that would, in the
- •opinion of the investigator, make this protocol unreasonably hazardous,
- •including but not limited to:
- •o Uncontrolled infection
- •o NYHA III or IV heart failure
- •o Crohn's disease or those with ulcerative colitis who have not undergone a
- •o Known active infection with HIV, Hepatitis B or Hepatitis C
研究者
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