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

JRCT ID: jRCTs051180140

Registered date:20/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: castration resistant prostate cancer
• Date of first enrollment: 04/03/2016
• Target sample size: 340
• Study type: Interventional

Intervention(s)

Part 1 prostate needle biopsy at the time of castration-resistance
Part 2 prostate needle biopsy at diagnosis and also at the time of castration- resistance
Part 3 phlebotomy to collect cell-free DNA and circulating tumor cells (CTC) before treatment with enzalutamide, at 3 months after starting treatment, and at the time of resistance to enzalutamide.

Outcome(s)

Primary Outcome

Part 1
Association between genetic profile of castration-resistant prostate cancer tissue with sensitivity to enzalutamide.

Part 2
Association between genetic aberration newly acquired during development of castration-resistance and sensitivity to enzalutamide.

Part 3
Association between genetic aberration of androgen receptor (AR) in cell-free DNA and/or CTC with sensitivity to enzalutamide.

Secondary Outcome

Part 1 and Part 2
Association between the genetic aberration detected in castration resistant prostate cancer tissues with those identified in cell-free DNA or CTC.

Part 3
Association between newly identified genetic aberration in cell-free DNA or CTC other than those in AR with sensitivity to enzalutamide.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

Part 1. Prostate needle biopsy for castration-resistant prostate cancer patients (enrollment: 20 patients)
<inclusion criteria>
- 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)
<inclusion criteria>
- 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)
<inclusion criteria>
-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.

Exclude criteria

Part 1. Prostate needle biopsy for castration-resistant prostate cancer patients
<exclusion criteria>
- 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
<exclusion criteria>
- 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
<exclusion criteria>
- patients who cannot provide written informed consent
- patients younger than 20.

Related Information

• Primary Sponsor: Akamatsu Shusuke
• Source(s) of Monetary Support: Astellas Pharma Inc.