ADEPT: Phase II neo-adjuvant study of Androgen Deprivation Therapy (Degarelix) and Erdafitinib in high-risk localized prostate cancer.

Melbourne Health (The Royal Melbourne Hospital)0 个研究点目标入组 9 人开始时间: 2018年6月26日最近更新: 2021年2月16日

适应症

试验速览

暂无简介。

•Histologically confirmed prostate cancer, present in at least 2 biopsy cores, associated with one of the following features: PSA >20 ng/ml, predominant cancer Gleason pattern 4 or above (Gleason 4+3=7, 8-10), clinical stage >/= T2c.
•Otherwise suitable for radical prostatectomy with curative intent.
•Normal organ and marrow function.

•The presence of bony metastatic disease.
•Prior systemic therapy for prostate cancer.
•Previous local therapy for prostate cancer including prior external beam radiotherapy, brachytherapy, HIFU or cryotherapy.
•Active hepatitis B or C infection
•Known active AIDS (human immunodeficiency virus (HIV) infection) unless the subject has been on a stable anti-retroviral therapy regimen for the last 6 months or more, has had no opportunistic infections in the last 6 months, and has CD4 count >350
•History or current evidence of endocrine alteration of calcium-phosphorus homeostasis
•History or current evidence of calcification/mineralisation of soft tissue or internal organs, with the exception of lymph node calcification or asymptomatic arterial calcification.
•History or current evidence of corneal disorder/keratopathy or retinal abnormality, confirmed by ophthalmologic examination.
•Uncontrolled hypertension
•Clinically significant cardiac disease
•History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study drug.
•Hypogonadism or severe androgen deficiency as defined by serum testosterone less than 100 ng/dL

发起方

Melbourne Health (The Royal Melbourne Hospital)