EUCTR2005-003680-22-CZ进行中（未招募）1 期
A double blind, randomised, dose finding, repeat dose, phase II, multicentre study of Alpharadin TM for the treatment of patients with hormone refractory prostate cancer and skeletal metastases. - N/A
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Algeta ASA
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Histologically or cytologically confirmed adenocarcinoma of the prostate.
- •2. Hormone refractory with evidence of rising PSA.
- •3. Multifocal skeletal metastases confirmed by bone scintigraphy within the last 12 weeks
- •4. Performance status: ECOG 0-2
- •5. Life expectancy: At least 6 months
- •6. Laboratory test results within required parameters.
- •7. The patient is willing and able to comply with the protocol (including maintenance of patient diary), and agrees to return to the hospital for follow-up visits and examination
- •8. The patient has been fully informed about the study and has signed the informed consent form
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Has received an investigational drug within 4 weeks prior to the administration of radium-223, or is scheduled to receive one during the treatment and post-treatment period
- •2. Has received chemo-, immunotherapy, or external radiotherapy within the last 4 weeks prior to administration of study drug, or has not recovered from adverse events due to agents administered more than 4 weeks earlier
- •3. More than one regimen of previous cytotoxic chemotherapy. Estramustine phosphate is allowed in addition to one regimen of a cytotoxic chemotherapy
- •4. Has received prior hemibody external radiotherapy.
- •5. Has a need for immediate external radiotherapy
- •6. Has received systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the last year prior to administration of study drug
- •7. Has started treatment with bisphosphonates less than 3 months prior to administration of study drug. Patients are allowed to be on bisphosphonates provided patient is on a stable dose for > 12 weeks before administration of study drug.
- •8. Patients who are <= 4 weeks (6 weeks for bicalutamide) post withdrawal of antiandrogen therapy
- •9. Patients who have started on systemic steroids, within a week prior to study drug administration or who have stopped steroids within a week prior to study drug administration
- •10. Other currently active (relapse within the last 3 years) malignancy (except non-melanoma skin cancer) that are not prostate cancer metastases
- •11. Visceral metastases from prostate cancer as assessed by abdominal/pelvic CT or MRI within eight weeks before administration of study drug; Lung lesions from prostate cancer as assessed by Chest Xray within 6 weeks. This requirement does not include abdominal or pelvic lymph node involvement (individual lymph node size must not exceed 1 cm in short diameter) which is acceptable.
- •12. Bulky loco-regional disease
- •13. Other serious illness or medical condition.
研究者
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