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Enzalutamide + ADT for Prostate Cancer (ARCHES Trial)
Phase 3
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 or metastatic lesions on CT or MRI scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until the data cut-off date of 14 october 2018; maximum duration of treatment was 26.6 months.
Awards & highlights
ARCHES Trial Summary
This trial studied whether adding the drug enzalutamide to androgen deprivation therapy (ADT) could help treat men with metastatic hormone-sensitive prostate cancer (mHSPC).
Who is the study for?
Adult men with advanced prostate cancer that has spread, who can take pills and follow the study rules. They must have a good performance status (able to carry out daily activities), no history of certain types of prostate cancer or brain metastasis, normal organ function, and not have had certain treatments for their cancer recently.Check my eligibility
What is being tested?
The trial is testing if adding enzalutamide to standard hormone therapy slows down cancer growth better than a placebo plus hormone therapy in men whose prostate cancer has spread but haven't received chemotherapy for it.See study design
What are the potential side effects?
Enzalutamide may cause fatigue, back pain, constipation, joint pain, hot flushes. It can also affect blood pressure and could lead to falls or fractures. Rarely it might cause seizures.
ARCHES Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific type of prostate cancer.
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My prostate cancer has spread, confirmed by scans.
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I am on hormone therapy for cancer or have had both testicles removed.
Select...
I am fully active or can carry out light work.
ARCHES Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization to the data cut-off date of 14 october 2018; maximum duration of treatment was 26.6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to the data cut-off date of 14 october 2018; maximum duration of treatment was 26.6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiographic Progression-Free Survival (rPFS) Based on Independent Central Review (ICR) of Bone Scan According to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Criteria
rPFS Based on ICR of Bone Scan According to Protocol Assessment Criteria
Secondary outcome measures
Objective Response Rate (ORR)
Overall Survival (OS)
PSA Undetectable Rate
+7 moreSide effects data
From 2017 Phase 4 trial • 215 Patients • NCT0211658234%
Fatigue
25%
Decreased appetite
18%
Asthenia
17%
Back pain
16%
Arthralgia
15%
Nausea
13%
Bone pain
13%
Diarrhoea
13%
Constipation
12%
Pain in extremity
12%
Weight decreased
11%
Anaemia
11%
Musculoskeletal pain
9%
Hypertension
8%
Oedema peripheral
7%
Dizziness
7%
Haematuria
6%
Insomnia
6%
Hot flush
6%
Malignant neoplasm progression
6%
Muscular weakness
5%
General physical health deterioration
5%
Vomiting
5%
Dyspnoea
3%
Spinal cord compression
2%
Renal failure acute
2%
Pneumonia
2%
Pulmonary embolism
1%
Cardiac failure
1%
Pyrexia
1%
Urinary tract infection
1%
Lower respiratory tract infection
1%
Neutropenia
1%
Metastases to central nervous system
1%
Lung disorder
1%
Renal failure
1%
Osteoarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Enzalutamide Total
ARCHES Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Placebo followed by EnzalutamideExperimental Treatment1 Intervention
Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Group II: Enzalutamide + Androgen Deprivation Therapy (ADT)Experimental Treatment1 Intervention
Participants received 160 mg enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or Luteinizing hormone-releasing hormone (LHRH) agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Group III: Placebo + Androgen Deprivation Therapy (ADT)Placebo Group1 Intervention
Participants received matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2760
Find a Location
Who is running the clinical trial?
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.Industry Sponsor
21 Previous Clinical Trials
8,784 Total Patients Enrolled
10 Trials studying Prostate Cancer
5,581 Patients Enrolled for Prostate Cancer
Astellas Pharma Global Development, Inc.Lead Sponsor
195 Previous Clinical Trials
120,347 Total Patients Enrolled
6 Trials studying Prostate Cancer
4,734 Patients Enrolled for Prostate Cancer
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,789 Previous Clinical Trials
8,066,180 Total Patients Enrolled
13 Trials studying Prostate Cancer
3,306 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious heart condition.I have taken bisphosphonates or denosumab recently for bone health.I am legally an adult as per my local laws.I have been diagnosed with a specific type of prostate cancer.My prostate cancer has spread, confirmed by scans.I am on hormone therapy for cancer or have had both testicles removed.I am fully active or can carry out light work.I have had treatment for metastatic prostate cancer, with some exceptions.I had major surgery less than 4 weeks ago.I have not taken estrogens, cyproterone acetate, or androgens in the last 4 weeks.I have not taken herbal medications for prostate cancer in the last 4 weeks.I have a history of seizures or conditions that could lead to seizures.I have brain metastasis or active leptomeningeal disease.I have taken medication for prostate enlargement within the last month.I have taken more than 10 mg of prednisone or similar daily in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Enzalutamide + Androgen Deprivation Therapy (ADT)
- Group 2: Placebo followed by Enzalutamide
- Group 3: Placebo + Androgen Deprivation Therapy (ADT)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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