Research to identify factors that predict response to enzalutamide using biopsy tissues from castration-resistant prostate cancer.

Not Applicable

Recruiting

• Conditions: castration resistant prostate cancer; D064129; prostate cancer, castration-resistant, enzalutamide

• Registration Number: JPRN-jRCTs051180140
• Lead Sponsor: Akamatsu Shusuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-20
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 340

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
- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Part 1<br>Association between genetic profile of castration-resistant prostate cancer tissue with sensitivity to enzalutamide.<br><br>Part 2<br>Association between genetic aberration newly acquired during development of castration-resistance and sensitivity to enzalutamide.<br><br>Part 3<br>Association between genetic aberration of androgen receptor (AR) in cell-free DNA and/or CTC with sensitivity to enzalutamide.

Secondary Outcome Measures

Name	Time	Method
Part 1 and Part 2<br>Association between the genetic aberration detected in castration resistant prostate cancer tissues with those identified in cell-free DNA or CTC.<br><br>Part 3<br>Association between newly identified genetic aberration in cell-free DNA or CTC other than those in AR with sensitivity to enzalutamide.