ARCHES:A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

Phase 3

Recruiting

Conditions: mHSPC
Prostate cancer
10038597

Registration Number: NL-OMON53121

Lead Sponsor: Astellas Pharma

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 42

Inclusion Criteria

- Subject is diagnosed with histologically or cytologically confirmed
adenocarcinoma of the prostate without neuroendocrine differentiation, signet
cell or small cell histology.
- Subject has metastatic prostate cancer documented by positive bone scan (for
bone disease) or metastatic lesions on CT or MRI scan (for soft tissue).
Subjects whose disease spread is limited to regional pelvic lymph nodes are not
eligible.
- Once randomized at day 1, subject must maintain ADT with an LHRH agonist or
antagonist during study treatment or have a history of bilateral orchiectomy
(i.e., medical or surgical castration).

Exclusion Criteria

- Subject has received any prior pharmacotherapy, radiation therapy or surgery
for metastatic prostate cancer (the following exceptions are permitted); these
are mentioned in the protocol.
- Subject received treatment with 5-a reductase inhibitors (finasteride,
dutasteride) within 4 weeks prior to day 1.
- Subject received treatment with estrogens, cyprotoerone acetate or androgens
within 4 weeks
prior to day 1.
- Subject received treatment with systemic glucocorticoids greater than the
equivalent of 10 mg per day of prednisone within 4 weeks prior to day 1,
intended for the treatment of prostate cancer.
- Subject received treatment with herbal medications that have known hormonal
antiprostate cancer activity and/or are known to decrease PSA levels within 4
weeks prior to day 1.
- Subject received prior aminoglutethimide, ketoconazole, abiraterone acetate
or enzalutamide for the treatment of prostate cancer or participation in a
clinical study of an investigational agent that inihibits the androgen receptor
or androgen synthesis (e.g., TAK-700, ARN-509, ODM-201).
- Subject received biphosphonates or denosumab within 2 weeks prior to day 1
unless administered at stable dose or to treat diagnosed osteoporosis.
- Subject has shown a hypersensitivity reaction to the active pharmaceutical
ingredient or any of the study capsule components, including Labrasol,
butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint<br /><br><br /><br>- rPFS: Defined as the time from randomization to the first objective evidence<br /><br>of radiographic disease progression as assessed by central review or death<br /><br>(defined as death from any cause within 24 weeks from study drug<br /><br>discontinuation), whichever occurs first.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Main Secondary Endpoints<br /><br><br /><br>- OS: Defined as the time from randomization to death from any cause.<br /><br>- Time to first SSE: Defined as the time from randomization to the occurrence<br /><br>of the first SSE. SSE is defined as radiation or surgery to bone, clinically<br /><br>apparent pathological bone fracture or spinal cord compression.<br /><br>- Time to castration resistance: Defined as the time from randomization to the<br /><br>first castration-resistant event (radiographic disease progression, PSA<br /><br>progression or SSE), whichever occurs first.</p><br>