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A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance (ENACT)

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ClinicalTrials.gov Identifier: NCT02799745
Recruitment Status : Active, not recruiting
First Posted : June 15, 2016
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Brief Summary:
The primary purpose of this study is to compare the time to prostate cancer progression (pathological or therapeutic progression) between patients treated with enzalutamide versus patients undergoing active surveillance.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Enzalutamide Other: Active Surveillance Phase 2

Detailed Description:
This is a multicenter, randomized, open label exploratory study, conducted in the US and Canada, evaluating the efficacy and safety of enzalutamide for extension of time to prostate cancer progression (pathological or therapeutic) in patients with clinically localized, histologically proven prostate cancer that is categorized as low risk or intermediate risk and who are under AS.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance (ENACT)
Actual Study Start Date : May 24, 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: Enzalutamide
Taken once daily
Drug: Enzalutamide
Oral
Other Names:
  • MDV3100
  • Xtandi

Active Surveillance (AS)
AS arm will not receive any study drug
Other: Active Surveillance



Primary Outcome Measures :
  1. Time to prostate cancer progression [ Time Frame: From study screening to end of study (up to three years after screening) ]
    Prostate cancer progression is defined as either therapeutic or pathological progression.


Secondary Outcome Measures :
  1. Safety assessed by adverse events (AE) [ Time Frame: Up to end of study (up to two years) ]
  2. Incidence of negative biopsies for cancer at 1 year [ Time Frame: 1 year ]
  3. Incidence of negative biopsies for cancer at 2 years [ Time Frame: 2 years ]
  4. Percent of cancer positive cores at 1 year [ Time Frame: 1 year ]
  5. Percent of cancer positive cores at 2 years [ Time Frame: 2 years ]
  6. Time to PSA (Prostate Specific Antigen) progression [ Time Frame: From study screening to end of study (up to three years after screening) ]
    Secondary rise in serum PSA>25% of baseline or >25% above nadir or absolute increase > 2ng/mL

  7. Incidence of secondary rise in serum PSA at 1 year [ Time Frame: 1 year ]
    Serum PSA>25% baseline or >25% above nadir or absolute increase > 2ng/mL

  8. Incidence of secondary rise in serum PSA at 2 years [ Time Frame: 2 years ]
    Serum PSA>25% baseline or >25% above nadir or absolute increase > 2ng/mL

  9. Brief Fatigue Index (BFI) [ Time Frame: Baseline up to 24 months, approximately every 3-6 months ]
  10. Medical Outcomes study 12-item short form (SF-12) assessments [ Time Frame: Baseline up to 24 months, approximately every 6 months ]
  11. Expanded Prostate Cancer Index Composite (EPIC) questionnaire (urinary, sexual and hormonal domains) [ Time Frame: Baseline up to 24 months, approximately every 6 months ]
  12. Memorial Anxiety Scale for Prostate Cancer (MAX-PC) questionnaire [ Time Frame: Baseline up to 24 months, approximately every 6 months ]
  13. Safety assessed by vital sign measurement: pulse [ Time Frame: Up to end of study (up to two years) ]
  14. Safety assessed by vital sign measurement: blood pressure [ Time Frame: Up to end of study (up to two years) ]
  15. Safety assessed by vital sign measurement: heart rate [ Time Frame: Up to end of study (up to two years) ]
  16. Safety assessed by vital sign measurement: body temperature [ Time Frame: Up to end of study (up to two years) ]
  17. Number of participants with abnormal laboratory values and/or adverse events related to treatment [ Time Frame: Up to end of study (up to two years) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven adenocarcinoma of the prostate diagnosed (with ≥10 core biopsy) within 6 months of screening. The biopsy that was used for this diagnosis must be submitted for central pathology review.
  • Prostate cancer categorized (as determined by central pathology review) as low risk is defined as T1c-T2a, PSA<10, N0, M0 (or presumed N0, M0 if CT/bone scan not done due to low risk of metastases), GS ≤ 6, ECOG status ≤2 and estimated life expectancy >5 years OR intermediate risk is defined as T2b-T2c, PSA<20, N0, M0 (or presumed N0, M0 if CT/bone scan not done), GS ≤7 (3+4 pattern only), ECOG status ≤ 2 and estimated life expectancy > 5 years. Prostate cancer categorized (as determined by central pathology review) to the very low risk category (T1c, GS ≤6, PSA <10 ng/mL, fewer than 3 prostate biopsy cores positive,

    ≤50% cancer in any core, PSA density <0.15 ng/mL/g) is not included.

  • Ability to swallow study drugs and to comply with study requirements throughout the study
  • Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures
  • Throughout study, male subject and a female partner who is of childbearing potential must use two acceptable methods of birth control (one of which must include a condom barrier method of contraception) starting at screening and continuing throughout the study period and for three months after the final study drug administration. Two acceptable methods of birth control thus include the following:

    1. Condom (barrier method of contraception) AND
    2. One of the following is required:

    i. Established use of oral, injected or implanted hormonal methods of contraception by the female partner; ii. Placement of an intrauterine device or intrauterine system by the female partner; iii. Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam / gel / film / cream / suppository by the female partner; iv. Tubal ligation in the female partner.

  • Must not donate sperm starting at screening throughout the study period and for 90 days after the final study drug administration.

Exclusion Criteria:

  • Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer
  • Very low risk category (T1c, GS ≤6, PSA <10 ng/mL, fewer than 3 prostate biopsy cores positive, ≤50% cancer in any core, PSA density <0.15 ng/mL/g)
  • Prior transurethral resection of the prostate or prior transurethral microwave thermotherapy of the prostate
  • Use of oral glucocorticoids within 1 month of screening
  • Use of 5 alpha reductase inhibitor within 1 month of screening or total use, within the last two years prior to screening, of >3 months
  • Presence of metastatic disease
  • History of seizure or any condition that may predispose to seizures at any time in the past. History of loss of consciousness or transient ischemic attack within 12 months of screening
  • Absolute neutrophil count < 1,500/μL, platelet count < 100,000/μL, or hemoglobin < 6.2 mmol/L (10 g/dL) at screening
  • Total bilirubin >1.5 times the upper limit of normal (ULN) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 X ULN at screening
  • Creatinine > 177 μmol/L (> 2 mg/dL) at screening
  • Albumin < 30 g/L (3.0 g/dL) at screening
  • Major surgery within 4 weeks prior to Randomization Visit
  • Clinically significant cardiovascular disease including:

    1. Myocardial infarction or uncontrolled angina within 6 months
    2. Congestive heart failure New York Heart Association (NYHA) class 3 or 4
    3. History of clinically significant ventricular arrhythmias
    4. History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
    5. Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mm Hg) at screening
    6. Bradycardia as indicated by a heart rate of < 45 beats per minute on the screening electrocardiogram (ECG) and on physical examination
    7. Uncontrolled hypertension as indicated by at least 2 consecutive measurements of a resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the Screening Visit
  • Known hypersensitivity to enzalutamide or any of its components.
  • Subject has received investigational therapy within 28 days or 5 half lives, whichever is longer, prior to screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02799745


  Hide Study Locations
Locations
United States, Alabama
Site US10034
Birmingham, Alabama, United States, 35223
Site US10024
Homewood, Alabama, United States, 35209
United States, Arizona
Site US10007
Tucson, Arizona, United States, 85704
Site US10055
Tucson, Arizona, United States, 85741
United States, California
Site US10004
Los Angeles, California, United States, 90048
Site US10026
Sacramento, California, United States, 95670
Site US10010
San Diego, California, United States, 92123
United States, Colorado
Site US10051
Aurora, Colorado, United States, 80045
Site US10029
Denver, Colorado, United States, 80211
Site US10054
Denver, Colorado, United States, 80220
United States, Florida
Site US10072
Bradenton, Florida, United States, 34205
Site US10057
Lakeland, Florida, United States, 33805
United States, Georgia
Site US10066
Atlanta, Georgia, United States, 30312
United States, Illinois
Site US10038
Chicago, Illinois, United States, 60611
Site US10062
Chicago, Illinois, United States, 60612
Site US10074
Chicago, Illinois, United States, 60612
Site US10070
Chicago, Illinois, United States, 60643
Site US10018
Glenview, Illinois, United States, 60026
Site US10071
Lake Barrington, Illinois, United States, 60010
United States, Indiana
Site US10046
Carmel, Indiana, United States, 46033
Site US10009
Jeffersonville, Indiana, United States, 47130
United States, Louisiana
Site US10037
New Orleans, Louisiana, United States, 70112
Site US10006
Shreveport, Louisiana, United States, 71106
United States, Maryland
Site US10001
Towson, Maryland, United States, 21204
United States, Massachusetts
Site US10032
Boston, Massachusetts, United States, 02111
United States, Michigan
Site US10008
Troy, Michigan, United States, 48084
United States, Nebraska
Site US10069
Lincoln, Nebraska, United States, 68516
Site US10044
Omaha, Nebraska, United States, 68114
Site US10067
Omaha, Nebraska, United States, 68130
United States, New Hampshire
Site US10061
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Site US10049
Morristown, New Jersey, United States, 07962
Site US10043
Voorhees, New Jersey, United States, 08043
United States, New York
Site US10068
Brooklyn, New York, United States, 11215
Site US10050
Cheektowaga, New York, United States, 14225
Site US10030
Garden City, New York, United States, 11530
Site US10028
Poughkeepsie, New York, United States, 12601
Site US10021
Syracuse, New York, United States, 13210
Site US10022
Syracuse, New York, United States, 13210
United States, North Carolina
Site US10047
Gastonia, North Carolina, United States, 28053
United States, Ohio
Site US10045
Cleveland, Ohio, United States, 44195
Site US10015
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
Site US10053
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Site US10063
Bala-Cynwyd, Pennsylvania, United States, 19004
Site US10052
Lancaster, Pennsylvania, United States, 17604
United States, Rhode Island
Site US10014
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Site US10019
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Site US10011
Nashville, Tennessee, United States, 37209
United States, Texas
Site US10056
Dallas, Texas, United States, 75231
Site US10036
Houston, Texas, United States, 77027
Site US10035
San Antonio, Texas, United States, 78229
United States, Virginia
Site US10058
Richmond, Virginia, United States, 23235
United States, Wisconsin
Site US10017
Milwaukee, Wisconsin, United States, 53226
Canada, British Columbia
Site CA15005
Abbotsford, British Columbia, Canada, V2S 3N6
Canada, Nova Scotia
Site CA15004
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Site CA15001
Toronto, Ontario, Canada, M4N3M5
Site CA15003
Toronto, Ontario, Canada, M5G2M9
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Medivation, Inc.
Investigators
Study Director: Medical Director Astellas Pharma Global Development, Inc.

Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT02799745     History of Changes
Other Study ID Numbers: 9785-MA-1010
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
Therapeutic Cancer Progression
Pathological Cancer Progression
Enzalutamide
Prostate Cancer
Active surveillance

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases