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Antiandrogen

Enzalutamide for Prostate Cancer

Phase 2
Waitlist Available
Led By Tom Beer, MD
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration); patients who have not had an orchiectomy must maintain effective GnRH-analogue therapy for the duration of the trial
Radiographic evidence of regional or distant metastases with suspected tumor in an area that is safe to biopsy
Must not have
A second active malignancy except adequately treated non-melanoma skin cancer or other non-invasive or in situ neoplasm
Previous treatment with enzalutamide (MDV3100)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial looks at how well a certain anti-hormone therapy works in treating prostate cancer, as well as how different genetic and molecular mechanisms may affect a patient's response to the therapy.

Who is the study for?
Men with advanced prostate cancer that's still growing despite hormone therapy can join. They must have had a recent rise in PSA levels or new areas of cancer spread on scans, be on ongoing hormone treatment, and their doctor should recommend enzalutamide. They need to agree to use birth control and not have other serious health issues or treatments that could interfere.
What is being tested?
The trial is testing how well the drug Enzalutamide works for prostate cancer by looking at genetic and molecular changes in blood and tissue samples. It aims to understand why some cancers resist treatment and improve future therapies.
What are the potential side effects?
Enzalutamide may cause fatigue, back pain, constipation, joint pain, hot flushes, diarrhea, high blood pressure, headaches, dizziness, swelling of arms/legs (peripheral edema), muscle weakness or spasms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on hormone therapy for cancer or have had surgery to remove my testicles.
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My scans show cancer spread that can be safely biopsied.
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My PSA levels have been rising, showing my prostate cancer is progressing.
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My prostate cancer is getting worse despite treatment to lower testosterone.
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My bone scan shows two or more new lesions indicating my bone disease is progressing.
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I am able to care for myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have another cancer, but it's either non-melanoma skin cancer or a non-invasive cancer that's been treated.
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I have been treated with enzalutamide before.
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I have been treated with medications that target hormone production or action for my cancer.
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I have had seizures, loss of consciousness, or a mini-stroke in the last year.
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I am not taking gemfibrozil or Bactrim.
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I haven't taken high doses of steroids in the last 4 weeks.
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I have a condition or had surgery that affects how my body absorbs nutrients.
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I have been treated with docetaxel for advanced prostate cancer.
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I have weak bones at risk of breaking.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Androgen Receptor (AR) Activity Level
Androgen Receptor (AR) Messenger RNA (mRNA) Expression
Androgen Receptor Variant 7 (AR-V7) Expression
+6 more
Secondary study objectives
Changes in Circulating Tumor Cell (CTC) Counts
Degree of Prostate-specific Antigen (PSA) Decline
Disease-specific Survival (DSS)
+8 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%
Constipation
13%
Diarrhoea
12%
Pain in extremity
12%
Weight decreased
11%
Anaemia
11%
Musculoskeletal pain
9%
Hypertension
8%
Oedema peripheral
7%
Haematuria
7%
Dizziness
6%
Malignant neoplasm progression
6%
Insomnia
6%
Hot flush
6%
Muscular weakness
5%
General physical health deterioration
5%
Vomiting
5%
Dyspnoea
3%
Spinal cord compression
2%
Renal failure acute
2%
Pulmonary embolism
2%
Pneumonia
1%
Pyrexia
1%
Renal failure
1%
Neutropenia
1%
Cardiac failure
1%
Lower respiratory tract infection
1%
Osteoarthritis
1%
Urinary tract infection
1%
Metastases to central nervous system
1%
Lung disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Enzalutamide Total

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (Enzalutamide)Experimental Treatment1 Intervention
Patients receive enzalutamide PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo a tumor biopsy of a metastatic site at study entry (prior to initiation of enzalutamide) and after the time of progression. Per the investigator, patients may continue treatment beyond progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2970

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
234 Previous Clinical Trials
2,088,591 Total Patients Enrolled
28 Trials studying Prostate Cancer
2,463 Patients Enrolled for Prostate Cancer
Oregon Health and Science UniversityOTHER
994 Previous Clinical Trials
7,386,912 Total Patients Enrolled
22 Trials studying Prostate Cancer
7,396 Patients Enrolled for Prostate Cancer
Astellas Pharma US, Inc.Industry Sponsor
88 Previous Clinical Trials
12,801 Total Patients Enrolled
4 Trials studying Prostate Cancer
102 Patients Enrolled for Prostate Cancer

Media Library

Enzalutamide (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT02099864 — Phase 2
Prostate Cancer Research Study Groups: Treatment (Enzalutamide)
Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT02099864 — Phase 2
Enzalutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02099864 — Phase 2
~3 spots leftby Sep 2025
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