JPRN-jRCTs051180140
Recruiting
N/A
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 sites340 target enrollmentMarch 20, 2019
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- castration resistant prostate cancer
- Sponsor
- Akamatsu Shusuke
- Enrollment
- 340
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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