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

NCT02799745

Last updated date
Study Location
Site US10034
Birmingham, Alabama, 35223, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance
Official Title  ICMJE A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance (ENACT)
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Enzalutamide
    Oral
    Other Names:
    • MDV3100
    • Xtandi
  • Other: Active Surveillance
Study Arms  ICMJE
  • Active Comparator: Enzalutamide
    Taken once daily
    Intervention: Drug: Enzalutamide
  • Active Surveillance (AS)
    AS arm will not receive any study drug
    Intervention: Other: Active Surveillance
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 26, 2018)
228
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2016)
222
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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/?L, platelet count < 100,000/?L, 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 ?mol/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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02799745
Other Study ID Numbers  ICMJE 9785-MA-1010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials:Study Protocol
Supporting Materials:Statistical Analysis Plan (SAP)
Supporting Materials:Clinical Study Report (CSR)
Time Frame:Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria:Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL:https://www.clinicalstudydatarequest.com/
Responsible Party Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
Study Sponsor  ICMJE Astellas Pharma Global Development, Inc.
Collaborators  ICMJE Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Investigators  ICMJE
Study Director:Medical DirectorAstellas Pharma Global Development, Inc.
PRS Account Astellas Pharma Inc
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP