JPRN-jRCTs031220430招募中2 期
Curative management for Oligo-Metastatic Prostate cancer combining Apalutamide and Radioablation for tumor Eradication: A Phase II randomized study (COMPARE study)
Kijima Toshiki0 个研究点目标入组 60 人开始时间: 2022年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
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
- >= 20age old 至 ot applicable（—）
- 性别
- Male
入选标准
- •Include patients that meet all of the following criteria:.
- •(1)Patients aged 20 years or older who can obtain informed consent
- •(2)Patients with histologically or cytologically confirmed prostate cancer without neuroendocrine carcinoma, signet-ring cell carcinoma, or small cell carcinoma morphology
- •(3)Patients who did not receive androgen deprivation therapy with GnRH agonists/antagonists, first-generation antiandrogens (bicalutamide, flutamide, prostar, etc.) or bilateral orchiectomy, or who were initiated these therapies within 6 months prior to study entry
- •(4)Patients with 1 - 3 bone, organ, or lymph node metastases detected by routine CT, MRI, or bone scintigraphy within 3 months
- •(5)Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •(6)Patients who are expected to live at least 2 years
- •(7)Patients who can comply with study protocol visits and other procedures
排除标准
- •Patients who meet any of the following criteria are not included in this study:
- •(1)Patients who have been treated with androgen deprivation therapy to treat prostate cancer (abiraterone acetate, apalutamide, enzalutamide, darolutamide), androgen receptor targeting agents, cytotoxic chemotherapy, ketoconazole, or olaparib
- •(2)Patients who used the study drug within 4 weeks of the study start date
- •(3)Patients with a history of invasive cancer other than prostate cancer within 3 years of study entry
- •(4)Patients with neutrophil count < 1,000/microliter, platelet count < 100,000/microliter, and hemoglobin < 10 g/dL at screening
- •(5)Patients with total bilirubin >= 1.5 times the upper limit of normal (ULN) and ALT and AST >= 2.5 times the ULN at screening
- •(6)Patients with creatinine levels > 2 mg/dL at screening
- •(7)Patients with albumin < 3.0 g/dL at screening
- •(8)Patients with a history of convulsive seizures or conditions that predispose to convulsive seizures
- •(9)Patients with clinically significant cardiovascular disease
- •(10)Patients with GI disorders affecting absorption
- •(11)Patients who underwent major surgery under general anesthesia within 4 weeks of study initiation
- •(12)Patients with a history of hypersensitivity to any of the ingredients of this product
- •(13)Patients with conditions that place the patient at undue risk, interfere with the completion of the study, or interfere with the analysis of the study results
- •(14)Patients with a past history of radiation therapy at the target for metastatic-directed therapy
研究者
相似试验
进行中（未招募）
1 期
STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug EfficacyProstate CancerEUCTR2004-000193-31-GBniversity College London12,000
招募中
1 期
Intensified treatment in patients with oligometastatic pancreatic cancer - multimodal surgical treatment versus systemic chemotherapy alone: a randomized controlled trial - METAPANColigometastatic pancreatic cancerCTIS2023-503558-10-00niversitaetsmedizin Goettingen425
进行中（未招募）
1 期
Metastasis-directed therapy, whether or not in combination with hormone therapy, in patients with prostate cancer recurrence after initial treatment and a maximum of 5 metastasen.EUCTR2022-000066-18-BEniversitaire Ziekenhuizen Leuven873
招募中
1 期
Metastasis-directed therapy, whether or not in combination with hormone therapy, in patients with prostate cancer recurrence after initial treatment and a maximum of 5 metastases.Oligorecurrent hormone-sensitive prostate cancer patientsCTIS2022-502373-42-00Z Leuven873
尚未招募
2 期
Treatment of limited Oligo Metastatic disease in Esophageal and Stomach carcinoma; TOMES trialstomach and esophagus cancerupperGi cancer10017990NL-OMON52125Antoni van Leeuwenhoek Ziekenhuis73