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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am on hormone therapy for cancer or have had surgery to remove my testicles.
Select...
My scans show cancer spread that can be safely biopsied.
Select...
My PSA levels have been rising, showing my prostate cancer is progressing.
Select...
My prostate cancer is getting worse despite treatment to lower testosterone.
Select...
My bone scan shows two or more new lesions indicating my bone disease is progressing.
Select...
I am able to care for myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Androgen Receptor (AR) Activity Level
Androgen Receptor (AR) Messenger RNA (mRNA) Expression
Androgen Receptor Variant 7 (AR-V7) Expression
+6 moreSecondary outcome measures
Changes in Circulating Tumor Cell (CTC) Counts
Degree of Prostate-specific Antigen (PSA) Decline
Disease-specific Survival (DSS)
+8 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
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
~2760
Find a Location
Who is running the clinical trial?
OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,690 Total Patients Enrolled
27 Trials studying Prostate Cancer
2,433 Patients Enrolled for Prostate Cancer
Oregon Health and Science UniversityOTHER
975 Previous Clinical Trials
7,386,176 Total Patients Enrolled
21 Trials studying Prostate Cancer
7,366 Patients Enrolled for Prostate Cancer
Astellas Pharma US, Inc.Industry Sponsor
88 Previous Clinical Trials
12,797 Total Patients Enrolled
4 Trials studying Prostate Cancer
102 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My hemoglobin level is below 9 g/dL and I haven't had growth factors or blood transfusions in the last week.I am on hormone therapy for cancer or have had surgery to remove my testicles.I have another cancer, but it's either non-melanoma skin cancer or a non-invasive cancer that's been treated.I have been treated with enzalutamide before.My scans show cancer spread that can be safely biopsied.My PSA levels have been rising, showing my prostate cancer is progressing.I have been treated with medications that target hormone production or action for my cancer.My doctor has recommended enzalutamide for my cancer progression.I stopped taking hormone therapy for my cancer at least 4-6 weeks ago, depending on the medication.It's been over 4 weeks since my last cancer treatment, or 3 weeks since my last radiation.I have had seizures, loss of consciousness, or a mini-stroke in the last year.I haven't used herbal products like saw palmetto in the last 4 weeks.I am not taking gemfibrozil or Bactrim.You are planning to start using a new, experimental treatment during the study.I haven't taken high doses of steroids in the last 4 weeks.I cannot stop taking aspirin, Coumadin, or other blood thinners before a biopsy due to medical reasons.I have a condition or had surgery that affects how my body absorbs nutrients.I haven't taken any prostate cancer or hormone-related drugs in the last 4 weeks.My prostate cancer is getting worse despite treatment to lower testosterone.My prostate cancer is confirmed and not purely small cell type.My bone scan shows two or more new lesions indicating my bone disease is progressing.I am able to care for myself and perform daily activities.I have been treated with docetaxel for advanced prostate cancer.I have weak bones at risk of breaking.I am willing to have a tumor biopsy now and if my cancer gets worse.I have brain metastases or active spinal cord disease, but treated spinal conditions are okay.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (Enzalutamide)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are taking part in this medical experiment?
"At this time, recruitment for the clinical trial has been suspended. Initially posted on February 5th 2014 and last updated September 20th 2022, it is no longer seeking participants. However, there are numerous other trials recruiting patients with adenocarcinoma – 6464 to be exact - as well as 98 studies related to Enzalutamide that are actively enrolling now."
Answered by AI
Is this research project currently looking for participants?
"As conveyed on clinicaltrials.gov, this particular medical trial is not presently enrolling new candidates; it was initially posted and last edited in February 2014 and September 2022 respectively. However, there are 6562 other trials actively seeking participants at the moment."
Answered by AI
What risks are associated with utilizing Enzalutamide?
"There is preliminary clinical data supporting the safety of Enzalutamide, therefore it is given a score of 2. However, there are currently no studies that demonstrate its therapeutic efficacy."
Answered by AI
Has Enzalutamide been evaluated in other research studies?
"In 2005, the initial research into enzalutamide was conducted within Rosemere Cancer Centre at Royal Preston Hospital. Presently, 85 trials have been finalized and 98 are actively running with a high concentration of studies centered around Portland, Oregon."
Answered by AI
What are the fundamental goals of this investigation?
"This study will be monitored over twelve weeks and aims to assess the Percentage of Participants With Retinoblastoma Gene (RB1) Copy Number Alterations and Mutations. Secondary objectives include Overall Survival, Disease-specific Survival, as well as changes in Prostate-Specific Antigen levels. Correlations between baseline molecular features and pathways will be assessed using a Cox regression model while Kaplan-Meier plots shall graphically illustrate survival distributions across categorical predictors."
Answered by AI
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