NCT01674270已完成2 期
Phase II Randomized Open Label Study of Neo-Adjuvant Degarelix vs. LHRH Agonist in Prostate Cancer Patients Prior to Radical Prostatectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Intratumoral androgen levels
研究概览
简要总结
To assess the effect of neo-adjuvant GnRH antagonist, degarelix, versus LHRH agonist on intratumoral levels of androgens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men >18 and =< 75 years of age
- •Willing and able to provide informed consent, either alone or with the aid of a translator
- •Histologically confirmed prostate cancer as determined by transrectal ultrasound (TRUS) guided prostate biopsy performed within 6 months of study enrolment
- •Gleason Score >= 7and/or prostate cancer that is clinical stage T2 disease.
- •Candidates for open radical prostatectomy considered surgically resectable by urologic evaluation
- •Normal organ and marrow function as defined by the following criteria:
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
排除标准
- •Previous or current use of hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, megestrol acetate, and ketoconazole)
- •History of receiving radiation to the pelvic area.
- •Previously received therapy with 5-alpha reductase inhibitors finasteride and/or dutasteride 4 weeks prior to randomization.
- •History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.
- •History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
- •Known hypersensitivity towards any component of the investigational medicinal product or Casodex (bicalutamide) or their excipients.
- •Marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval >450 ms).
- •History of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome).
- •Previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years.
- •Clinically significant laboratory abnormalities (e.g. severe renal or hepatic impairment) which in the judgment of the Investigator would affect the patient's health or the outcome of the trial.
- •Clinically significant disorder (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
- •Use of natural medicines thought to have endocrine effects on prostate cancer (e.g. saw palmetto and St. John's Wort) 4 weeks prior to randomization.
- •Mental incapacity or language barrier precluding adequate understanding or co operation.
- •Use of an investigational drug within the last 28 days preceding the Screening Visit or longer if considered to possibly influence the outcome of the current trial.
- •Previously participated in any degarelix trial.
研究组 & 干预措施
Degarelix
Experimental
Degarelix Alone
干预措施: Degarelix (Drug)
Degarelix + Casodex
Experimental
Degarelix and Casodex
干预措施: Degarelix (Drug)
Degarelix + Casodex
Experimental
Degarelix and Casodex
干预措施: Casodex (Drug)
LHRH Agonist + Casodex
Active Comparator
LHRH Agonist and Casodex
干预措施: Casodex (Drug)
LHRH Agonist + Casodex
Active Comparator
LHRH Agonist and Casodex
干预措施: LHRH Agonist (Drug)
结局指标
主要结局
Intratumoral androgen levels
时间窗: Week 12
次要结局
- Prostate tumour morphology related to androgen withdrawal after neo-adjuvant therapy(Week 12)
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
2 期
Neoadjuvant Degarelix With or Without Apalutamide (ARN-509) Followed by Radical ProstatectomyProstatectomyNeoadjuvant TherapyAndrogen AntagonistsProstate CancerNCT03080116Universitaire Ziekenhuizen KU Leuven90
终止
2 期
Durvalumab and Standard Chemotherapy Before Surgery in Treating Patients With Variant Histology Bladder CancerBladder AdenocarcinomaBladder Mixed AdenocarcinomaBladder Squamous Cell CarcinomaBladder Urothelial CarcinomaInfiltrating Bladder Urothelial Carcinoma Sarcomatoid VariantInfiltrating Bladder Urothelial Carcinoma With Giant CellsInfiltrating Bladder Urothelial Carcinoma With Glandular DifferentiationInfiltrating Bladder Urothelial Carcinoma With Trophoblastic DifferentiationInfiltrating Bladder Urothelial Carcinoma, Clear Cell VariantInfiltrating Bladder Urothelial Carcinoma, Micropapillary VariantInfiltrating Bladder Urothelial Carcinoma, Nested VariantInfiltrating Bladder Urothelial Carcinoma, Plasmacytoid VariantNCT03912818Stanford University7
已完成
2 期
Feasibility and Toxicity of Degarelix for Prostate Downsizing Prior to Permanent Seed Prostate BrachytherapyProstate CancerNCT01446991British Columbia Cancer Agency50
进行中（未招募）
2 期
Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]HER2-positive Breast CancerBreast CancerNCT03747120University of Texas Southwestern Medical Center138
进行中（未招募）
2 期
Neoadjuvant Plus Adjuvant Treatment with Cemiplimab in Cutaneaous Squamous Cell CarcinomaCutaneous Squamous Cell CarcinomaNCT04632433Fondazione Melanoma Onlus25