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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 below

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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.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to the data cut-off date of 14 october 2018; maximum duration of treatment was 26.6 months for reporting.

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 more

Side effects data

From 2017 Phase 4 trial • 215 Patients • NCT02116582

34%

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

Hypertension

Oedema peripheral

Dizziness

Haematuria

Insomnia

Hot flush

Malignant neoplasm progression

Muscular weakness

General physical health deterioration

Vomiting

Dyspnoea

Spinal cord compression

Renal failure acute

Pneumonia

Pulmonary embolism

Cardiac failure

Pyrexia

Urinary tract infection

Lower respiratory tract infection

Neutropenia

Metastases to central nervous system

Lung disorder

Renal failure

Osteoarthritis

100%

80%

60%

40%

20%

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.Industry Sponsor

21 Previous Clinical Trials

8,783 Total Patients Enrolled

10 Trials studying Prostate Cancer

5,580 Patients Enrolled for Prostate Cancer

Astellas Pharma Global Development, Inc.Lead Sponsor

192 Previous Clinical Trials

119,912 Total Patients Enrolled

6 Trials studying Prostate Cancer

4,734 Patients Enrolled for Prostate Cancer

Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.

2,777 Previous Clinical Trials

8,062,330 Total Patients Enrolled

13 Trials studying Prostate Cancer

3,306 Patients Enrolled for Prostate Cancer

Media Library

Androgen Deprivation Therapy (ADT) Clinical Trial Eligibility Overview. Trial Name: NCT02677896 — Phase 3

Prostate Cancer Research Study Groups: Enzalutamide + Androgen Deprivation Therapy (ADT), Placebo followed by Enzalutamide, Placebo + Androgen Deprivation Therapy (ADT)

Prostate Cancer Clinical Trial 2023: Androgen Deprivation Therapy (ADT) Highlights & Side Effects. Trial Name: NCT02677896 — Phase 3

Androgen Deprivation Therapy (ADT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02677896 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals has this clinical trial set out to accomplish?

"The primary objective of this study, as measured over a From randomization until the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months time span, is rPFS Based on ICR of Bone Scan According to Protocol Assessment Criteria. Additionally, the trial will be measuring secondary outcomes including Time to First Symptomatic Skeletal Event (SSE) which is defined as Time to first SSE was calculated as the time from randomization to the occurrence of the first SSE prior to the data analysis cut-off date. An SSE was defined as radiation to bone, surgery to"

Answered by AI

When did Enzalutamide gain FDA approval?

"Enzalutamide is classified as a Phase 3 drug, meaning that there is both some evidence of efficacy and multiple rounds of data supporting safety. Therefore, our team rates it as having a potential risk level of 3."

Answered by AI

If so, could you share the efficacy data of Enzalutamide from prior clinical trials?

"Enzalutamide is being studied in 103 clinical trials, 30 of which are still active. Most of these studies are focusing on Phase 3 data. However, there are 5748 locations worldwide where Enzalutamide trials are taking place, with the majority of those located in Germantown, Tennessee."

Answered by AI