NL-OMON38355招募中3 期
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients with Metastatic Castration-Resistant Prostate Cancer - Study of Aberaterone Acetate in metastatic prostate cancer
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 35
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
- •4. Histologically or cytologically confirmed adenocarcinoma of the prostate
- •5. Metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT, MRI. If lymph node metastasis is the only evidence of metastasis, it must be >= 2 cm in diameter
- •6. Prostate cancer progression documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria
- •7. Asymptomatic or mildly symptomatic from prostate cancer. A score of 0-1 on BPI-SF Question #3 (worst pain in last 24 hours) will be considered asymptomatic, and a score of 2-3 will be considered mildly symptomatic.
- •8. Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM). If the patient is being treated with LHRH agonists (patient who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to Cycle 1 Day 1 and must be continued throughout the study.
- •9. Previous anti-androgen therapy and progression after withdrawal. Patients who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment (>= 4 weeks since last flutamide,>= 6 weeks since last bicalutamide or nilutamide).
- •10. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
排除标准
- •1. Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
- •2. Any chronic medical condition requiring a higher dose of corticosteroid than 5mg
- •prednisone/prednisolone bid.
- •3. Pathological finding consistent with small cell carcinoma of the prostate
- •4. Liver or visceral organ metastasis
- •5. Known brain metastasis
- •6. Use of opiate analgesics for cancer-related pain, including codeine and
- •dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
- •7. Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
- •8. Radiation therapy for treatment of the primary tumor within 6 weeks of Cycle 1, Day 1
- •9. Radiation or radionuclide therapy for treatment of metastatic CRPC
- •10. Previously treated with ketoconazole for prostate cancer for greater than 7 days
- •11. Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1
- •12. Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1, Day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day 1)
- •13. Bicalutamide (Casodex), nilutamide (andron) within 6 weeks of Cycle 1 Day 1
- •(patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day 1)
研究者
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