Identification of factors predicting response to enzalutamide using tissues of castration-resistant prostate cancer. - Identification of factors predicting response to enzalutamide using tissues of castration-resistant prostate cancer.

Akamatsu Shusuke0 个研究点目标入组 340 人开始时间: 2019年3月20日最近更新: 2024年4月23日

适应症

试验速览

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•Part 1. Prostate needle biopsy for castration-resistant prostate cancer patients (enrollment: 20 patients)
•- Acquired castration resistance (PSA >= 2ng/ml and increase over 25% above nadir) while on androgen deprivation therapy for metastatic advanced prostate cancer.
•- Sign of residual tumor in prostate by MRI.
•Part 2. Prostate needle biopsy before starting any treatment and again after acquiring castration-resistance for patients who have locally advanced prostate cancer (enrollment: 20 patients)
•- Untreated patients suspect to have advanced prostate cancer.
•- PSA>= 50ng/ml
•- Stony hard prostate by digital rectal examination.
•Part 3. Serial blood genomic marker analysis in patients treated with enzalutamide (enrollment: 300 patients)
•-Castration-resistant prostate cancer patient who has gained resistance to ongoing therapy (either rising PSA or radiographic progression), and who is planned to be started on treatment with enzalutamide.

•Part 1. Prostate needle biopsy for castration-resistant prostate cancer patients
•- patients who cannot undergo safe prostate needle biopsy due to co-morbidity
•- patients with history of significant adverse event by prostate needle biopsy
•- patients who are allergic to the ingredients included in enzalutamide capsule or tablet
•- patients who cannot provide written informed consent
•- patients younger than 20.
•Part 2. Prostate needle biopsy before starting any treatment and again after acquiring castration-resistance for patients who have locally advanced prostate cancer
•- patients who cannot undergo safe prostate needle biopsy due to co-morbidity
•- patients who are allergic to the ingredients included in enzalutamide capsule or tablet
•- patients who cannot provide written informed consent
•- patients younger than 20.
•Part 3. Serial blood genomic marker analysis in patients treated with enzalutamide
•- patients who cannot provide written informed consent
•- patients younger than 20.

发起方

Akamatsu Shusuke