Enzalutamide for Prostate Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Cabrini Hospital- Education and Research Precinct, Malvern, Australia
Prostate Cancer+2 More
Enzalutamide - Drug
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called enzalutamide is safe and effective for treating prostate cancer.

See full description

Eligible Conditions

  • Prostate Cancer
  • non-metastatic, castration-resistant prostate cancer

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Enzalutamide will improve 1 primary outcome and 46 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of From randomization until radiographic progression at any time, or death within 112 days of treatment discontinuation, whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months).

Week 17
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Status Visual Analog Score (VAS)
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 31
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 32
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 33
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 34
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 35
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 36
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 37
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 38
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 39
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 40
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 41
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 42
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 43
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 44
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 45
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 46
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 47
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 48
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 49
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 50
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 51
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 52
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 53
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 54
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 55
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Anxiety/ Depression Domain Score
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Mobility Domain Score
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Pain/Discomfort Domain Score
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Self-Care Domain Score
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Usual Activities Domain Score
Month 8
Number of Participants With Clinically Significant Vital Signs
Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs)
Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Chemistry
Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Hematology
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants With Treatment-Emergent Adverse Events Greater Than or Equal to Grade 3, Based on National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE), Version 4.0
Month 8
Overall Survival
Month 8
Percentage of Participants With Prostate Specific Antigen (PSA) Response
Time to Prostate-Specific Antigen (PSA) Progression
Month 8
Time to First Use of New Antineoplastic Therapy
Month 8
Time to Pain Progression
Month 8
Metastasis Free Survival (MFS)
Month 8
Chemotherapy-Free Survival
Month 8
Chemotherapy-Free Disease Specific Survival
Month 8
Time to First Use of Cytotoxic Chemotherapy

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Side Effects for

Enzalutamide Total
Fatigue
34%
Decreased appetite
25%
Asthenia
18%
Back pain
17%
Arthralgia
16%
Nausea
15%
Constipation
13%
Diarrhoea
13%
Bone pain
13%
Weight decreased
12%
Pain in extremity
12%
Musculoskeletal pain
11%
Anaemia
11%
Hypertension
9%
Oedema peripheral
8%
Haematuria
7%
Dizziness
7%
Malignant neoplasm progression
6%
Muscular weakness
6%
Insomnia
6%
Hot flush
6%
General physical health deterioration
5%
Vomiting
5%
Dyspnoea
5%
Spinal cord compression
3%
Pneumonia
2%
Pulmonary embolism
2%
Renal failure acute
2%
Cardiac failure
1%
Lower respiratory tract infection
1%
Urinary tract infection
1%
Metastases to central nervous system
1%
Lung disorder
1%
Renal failure
1%
Neutropenia
1%
Pyrexia
1%
Osteoarthritis
1%
Inflammation
0%
Anaemia of malignant disease
0%
Acute myocardial infarction
0%
Cardiovascular disorder
0%
Large intestinal obstruction
0%
Mitral valve incompetence
0%
Abdominal distension
0%
Intestinal obstruction
0%
Rectal haemorrhage
0%
Device occlusion
0%
Cellulitis
0%
Groin pain
0%
Fall
0%
Acidosis
0%
Pyelonephritis
0%
Pulmonary sepsis
0%
Lumbar vertebral fracture
0%
Rib fracture
0%
Hypercalcaemia
0%
Monoclonal immunoglobulin present
0%
Fluid retention
0%
Subdural haematoma
0%
Osteonecrosis of jaw
0%
Metastases to meninges
0%
Intervertebral disc protrusion
0%
Cancer pain
0%
Adenocarcinoma of colon
0%
Basal cell carcinoma
0%
Encephalitis
0%
Oral neoplasm benign
0%
Syncope
0%
Aphasia
0%
Ureteric cancer
0%
Loss of consciousness
0%
Vertebral artery thrombosis
0%
Monoparesis
0%
Metastases to lymph nodes
0%
Metastases to liver
0%
Renal colic
0%
Cerebral infarction
0%
Ureteric stenosis
0%
Pneumonitis
0%
Transient ischaemic attack
0%
Anxiety
0%
Confusional state
0%
Chronic obstructive pulmonary disease
0%
Shoulder arthroplasty
0%
Ileostomy closure
0%
Pulmonary hypertension
0%
Drug eruption
0%
Disseminated intravascular coagulation
0%
Acute coronary syndrome
0%
Dental fistula
0%
Malaise
0%
Gastroenteritis viral
0%
Device related infection
0%
Neck pain
0%
Spinal disorder
0%
Nerve root compression
0%
Disorientation
0%
Bladder tamponade
0%
Epiglottic mass
0%
Urinary retention
0%
Death
0%
Implantable defibrillator insertion
0%
Procedural intestinal perforation
0%
Pain
0%
Urinary incontinence
0%
Left ventricular dysfunction
0%
Bladder transitional cell carcinoma
0%
Metastatic pain
0%
Transitional cell carcinoma
0%
Ileus
0%
Thrombocytopenia
0%
Erysipelas
0%
Peripheral arterial occlusive disease
0%
Bronchopneumonia
0%
Enterobacter sepsis
0%
Hyperglycaemia
0%
Hydronephrosis
0%
This histogram enumerates side effects from a completed 2017 Phase 4 trial (NCT02116582) in the Enzalutamide Total ARM group. Side effects include: Fatigue with 34%, Decreased appetite with 25%, Asthenia with 18%, Back pain with 17%, Arthralgia with 16%.

Trial Design

2 Treatment Groups

Enzalutamide
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 1401 total participants across 2 different treatment groups

This trial involves 2 different treatments. Enzalutamide is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Enzalutamide
Drug
160 mg by mouth once daily
Placebo
Drug
Sugar pill manufactured to mimic enzalutamide 40 mg capsule
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization until onset of pain progression (until the data cut-off date of 28 june 2017, maximum duration of treatment: 42.8 months)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from randomization until onset of pain progression (until the data cut-off date of 28 june 2017, maximum duration of treatment: 42.8 months) for reporting.

Closest Location

Duke Women's Cancer Care Raleigh - Raleigh, NC

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration) may be associated with an increased incidence of myocardial infarction. show original
A cancer that is not causing any symptoms. show original
A person with an ECOG performance status of 0 or 1 is considered to have a good prognosis. show original
A prostate cancer that is histologically or cytologically confirmed to be an adenocarcinoma without features of neuroendocrine differentiation, signet cells, or small cells. show original
PSA doubling time ≤ 3 months The PSA doubling time is less than or equal to 10 months or 3 months. show original
thoracentesis is negative There is no evidence of metastatic disease and the thoracentesis is negative. show original
The patient has a testosterone level of 50 ng/dL or lower at screening. show original
The individual has a progressive disease and is on androgen deprivation therapy when they enroll in the study. show original
The estimated life expectancy for this patient is greater than 12 months. show original

Patient Q&A Section

What are the signs of prostate cancer?

"The signs of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) present in men with LUTS do not differ from patients with LUTS but without prostate cancer. The most useful sign of prostate cancer was an elevated PSA level. The decision to perform a prostate biopsy should be based on the PSA serum level." - Anonymous Online Contributor

Unverified Answer

What causes prostate cancer?

"There is a large variability in the timing of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) in men with BPH. Men with BPH with early cancer may have a different profile of risk factors for prostate cancer than men with BPH with late cancer." - Anonymous Online Contributor

Unverified Answer

What is prostate cancer?

"Prostate cancer typically appears in men over the age of 50 and forms in the prostate. It often forms by the time a man reaches 50 and can form over 10 years. Prostate cancer is the number one cause of cancer related deaths. And while not curable, prostate cancer can be controlled. If a man has prostate cancer, his doctor should be notified within 6 months to prevent other complications." - Anonymous Online Contributor

Unverified Answer

What does enzalutamide usually treat?

"Enzalutamide is used to treat many types of testosterone-dependent androgen-inhibiting conditions, such as prostate cancer, hirsutism, and hyperandrogenism. These conditions have an increased risk of cardiovascular diseases. Enzalutamide prevents estrogen and androgen-induced breast and endometrium development and function. Additionally, because endometrial hyperplasia and polyps are frequent side effects of NSAAs and are associated with high morbidity and mortality, enzalutamide does not worsen these common adverse effects. Enzalutamide lowers blood glucose and cardiovascular risk by inhibiting certain aspects of the androgen synthesis pathway." - Anonymous Online Contributor

Unverified Answer

Is enzalutamide safe for people?

"Our analysis revealed that in patients taking enzalutamide, there was no statistically significant association in any adverse or serious adverse event with enzalutamide compared to placebo. Adverse reactions of the treatment were similar." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving enzalutamide?

"Based on this small study, enzalutamide monotherapy appears to be effective enough in the treatment of metastatic castration-refractory prostate cancer (CRPC) without significant side effects. EPRS had only one patient in this small study, and the duration of response was 4.9 months, less than the 6 months' response seen with enzalutamide at 20 mg/d in a Phase I trial in 2007. EPRS demonstrated the longest duration of response reported to date in patients with CRPC. Further, enzalutamide was well tolerated in the majority of patients. More data are now required before using enzalutamide monotherapy in the treatment of CRPC." - Anonymous Online Contributor

Unverified Answer

Can prostate cancer be cured?

"There is no convincing evidence that [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) can be cured or has been curable. Radical prostatectomy, external beam radiation, and hormone therapy are all palliative treatments that have been used to treat patients whose prostate cancer has progressed after radical prostatectomy. Radical prostatectomy is often combined with intraoperative pelvic radiation, pelvic lymphadenectomy or androgen deprivation therapy to treat localized or locally advanced disease. The use of this multimodal therapy approach after radical prostatectomy has increased since the mid 1990s. Radical prostatectomy alone has not been proven to confer a significant long term survival benefit in men with localized prostate cancer." - Anonymous Online Contributor

Unverified Answer

What are common treatments for prostate cancer?

"The treatment paradigm for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) has shifted from a traditional, disease-fighting role of radical prostatectomy and definitive radiation therapy to a more personalized approach that focuses on alleviating the patient's symptoms while still allowing the disease to be treated if appropriate." - Anonymous Online Contributor

Unverified Answer

How many people get prostate cancer a year in the United States?

"It is estimated that a total of 13,250 men are diagnosed with PC in the U.S. each year. Estimates of the annual age-adjusted incidence of PC in the U.S. are the following: non-Hispanic blacks 6,970, non-Hispanic whites 16,200, Hispanics 21,400, men of other races 16,350, and unknown race, age 17, and unknown sex 19,100." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating prostate cancer?

"Overall, no new treatments have been discovered that have been shown to increase mortality from [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), but clinical trials have been conducted for new cancer therapies that are currently in development for prostate cancer. These new treatments may decrease the use of external beam radiotherapy and/or hormonal therapy, and increase the use of brachytherapy treatment." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for prostate cancer?

"Prostate cancer has historically been an extremely lethal disease, but survival rates have improved in recent years. In the present era, with better cancer treatment modalities and the increasing understanding of the mechanisms of prostate cancer, survival rates are greater now than they had been previously." - Anonymous Online Contributor

Unverified Answer

Does enzalutamide improve quality of life for those with prostate cancer?

"In our study of patients with advanced prostate cancer treated with enzalutamide, it was observed that enzalutamide did not improve patient-reported physical and mental quality of life. These data may help physicians better counsel patients with their treatment options." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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