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Trial record 2 of 46 for:    astellas medivation

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

This study is currently recruiting participants.
Verified October 2017 by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02799745
First Posted: June 15, 2016
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
  Purpose
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 Intervention Phase
Prostate Cancer Drug: Enzalutamide Other: Active Surveillance Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):

Primary Outcome Measures:
  • 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:
  • Safety assessed by adverse events (AE) [ Time Frame: Up to end of study (up to two years) ]
  • Incidence of negative biopsies for cancer at 1 year [ Time Frame: 1 year ]
  • Incidence of negative biopsies for cancer at 2 years [ Time Frame: 2 years ]
  • Percent of cancer positive cores at 1 year [ Time Frame: 1 year ]
  • Percent of cancer positive cores at 2 years [ Time Frame: 2 years ]
  • 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

  • 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

  • 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

  • Brief Fatigue Index (BFI) [ Time Frame: Baseline up to 24 months, approximately every 3-6 months ]
  • Medical Outcomes study 12-item short form (SF-12) assessments [ Time Frame: Baseline up to 24 months, approximately every 6 months ]
  • Expanded Prostate Cancer Index Composite (EPIC) questionnaire (urinary, sexual and hormonal domains) [ Time Frame: Baseline up to 24 months, approximately every 6 months ]
  • Memorial Anxiety Scale for Prostate Cancer (MAX-PC) questionnaire [ Time Frame: Baseline up to 24 months, approximately every 6 months ]
  • Safety assessed by vital sign measurement: pulse [ Time Frame: Up to end of study (up to two years) ]
  • Safety assessed by vital sign measurement: blood pressure [ Time Frame: Up to end of study (up to two years) ]
  • Safety assessed by vital sign measurement: heart rate [ Time Frame: Up to end of study (up to two years) ]
  • Safety assessed by vital sign measurement: body temperature [ Time Frame: Up to end of study (up to two years) ]
  • 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) ]

Estimated Enrollment: 222
Actual Study Start Date: May 24, 2016
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Astellas Pharma Global Development 800-888-7704 ext 5473 astellas.registration@astellas.com

  Show 59 Study Locations
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Medivation, Inc.
Investigators
Study Director: Medical Director Astellas Pharma Global Development, Inc.
  More Information

Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT02799745     History of Changes
Other Study ID Numbers: 9785-MA-1010
First Submitted: February 29, 2016
First Posted: June 15, 2016
Last Update Posted: October 23, 2017
Last Verified: October 2017
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