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Prostate CancerPhase 2STRIVENCT01664923

Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer

A Phase 2 study testing Enzalutamide and Bicalutamide in people with Prostate Cancer, run by Pfizer at 109 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine the safety and efficacy of enzalutamide vs bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have disease progression despite primary androgen deprivation therapy. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Enzalutamide and Bicalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
396 participants
Where
109 sitesUnited States
Study dates
Aug 2012to Jan 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males age 18 or older;
  • Histologically or cytologically confirmed adenocarcinoma of the prostate;
  • Ongoing androgen deprivation therapy;
  • Serum testosterone level ≤ 50 ng/dL (1.73 nmol/L) at the Screening visit;
  • Progressive disease at study entry defined by prostate-specific antigen (PSA) progression and/or radiographic progression that occurred while the patient was on primary androgen deprivation therapy;
  • Asymptomatic or mildly symptomatic from prostate cancer;
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  • Estimated life expectancy of ≥ 12 months;
  • Able to swallow the study drug and comply with study requirements.
  • Received randomized double blind treatment in MDV3100-09 as follows:
  • Randomized to enzalutamide and receiving enzalutamide at the time of study unblinding;
  • Randomized to bicalutamide and receiving bicalutamide at the time of study unblinding;
  • Randomized to bicalutamide and discontinued bicalutamide before study unblinding;
  • Willing to maintain androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) agonist/antagonist or has had a bilateral orchiectomy.

Who cannot join

  • Severe concurrent disease, infection, or co-morbidity;
  • Known or suspected brain metastasis or active leptomeningeal disease;
  • History of another invasive malignancy within the previous 5 years other than treated non-melanomatous skin cancer and American Joint Committee on Cancer (AJCC) Stage 0 or Stage 1 cancers that have a remote probability of recurrence;
  • Absolute neutrophil count < 1,500/µL, or platelet count < 100,000/µL, or hemoglobin < 9 g/dL at the Screening visit;
  • Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal (ULN) at the Screening visit;
  • Creatinine > 2 mg/dL at the Screening visit;
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  • Albumin < 3.0 g/dL at the Screening visit;
  • History of seizure or any condition that may predispose to seizure;
  • Clinically significant cardiovascular disease;
  • Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last 3 months);
  • Major surgery within 4 weeks of enrollment;
  • Use of opiate analgesics for pain from prostate cancer within 4 weeks of enrollment;
  • Radiation therapy for treatment of the primary tumor within 3 weeks of enrollment;
  • Prior radiation or radionuclide therapy for treatment of distant metastases;
  • Prior ketoconazole, abiraterone, or cytotoxic chemotherapy for prostate cancer;
  • Treatment with hormonal therapy or biologic therapy for prostate cancer within 4 weeks of enrollment;
  • Use of antiandrogens within 4 weeks prior to enrollment;
  • Prior disease progression, as assessed by the Investigator, while receiving bicalutamide;
  • Participation in a previous clinical trial of enzalutamide or an investigational agent that inhibits the androgen receptor or androgen synthesis (patients who received placebo are acceptable);
  • Use of an investigational agent within 4 weeks of enrollment;
  • Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids for prostate cancer within 4 weeks of enrollment;
  • Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.
  • Open-Label Treatment Period:
  • Is currently or has taken commercially available enzalutamide (Xtandi) prior to participation in this open-label extension;
  • Discontinued enzalutamide during the double-blind portion of the study prior to unblinding;
  • Has any clinically significant cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, hepatic, infectious, metabolic, neurologic, psychiatric, psychologic, pulmonary, or renal disorder or any other condition, including excessive alcohol or drug abuse, or secondary malignancy, that may interfere with study participation in the opinion of the investigator or medical monitor;
  • Has a current or previously treated brain metastasis or leptomeningeal disease;
  • Has a history of seizure or any condition that may predispose to seizure (eg, prior cortical stroke or significant brain trauma);
  • Has a history of loss of consciousness or transient ischemic attack within 12 months of open label day 1;
  • Has taken cytotoxic chemotherapy or investigational therapy within 4 weeks before enrollment (open label day 1).

Trial locations and contacts

109 sites in 1 country.

109 sites in 1 country

United States109 sites

  • Southern California Permanente Medical Group

    Anaheim, California, 92806

  • Kaiser Permanente Medical Center Lab Drawing Station

    Antioch, California, 94509

  • Kaiser Permanente Medical Center Lab Drawing Station

    Antioch, California, 94531

  • Anschutz Cancer Center Pavilion Pharmacy

    Aurora, Colorado, 80045

  • Anschutz Inpatient Pavilion

    Aurora, Colorado, 80045

  • University of Colorado Cancer Center, Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • University of Alabama at Birmingham，IDS Pharmacy

    Birmingham, Alabama, 35249

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Charleston Hematology Oncology Associates, PA

    Charleston, South Carolina, 29414

  • Carolinas Medical Center-Steelcreek

    Charlotte, North Carolina, 28278

  • TriState Urologic Services PSC Inc., dba The Urology Group

    Cincinnati, Ohio, 45212

  • Cleveland Clinic Taussig Cancer Institute

    Cleveland, Ohio, 44195

  • Carolina Clinical Trials, LLC

    Concord, North Carolina, 28025

  • Carolina Urology Partners, PLLC

    Concord, North Carolina, 28025

  • Barnes-Jewish West County Hospital

    Creve Coeur, Missouri, 63141

  • Urology Clinics of North Texas

    Dallas, Texas, 75231

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Advanced Urology institute

    Daytona Beach, Florida, 32114

  • The Urology Center of Colorado

    Denver, Colorado, 80211

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Investigational Chemotherapy Services

    Durham, North Carolina, 27710

  • Minnesota Oncology Hematology, P.A.

    Edina, Minnesota, 55435-2150

  • Kaiser Permanente Medical Center Lab Drawing Station

    Fairfield, California, 94533-6901

  • Peace Harbor Hospital

    Florence, Oregon, 97439

  • AccuMed Research Associates

    Garden City, New York, 11530

  • Kaiser Permanente Medical Center Lab Drawing Station

    Gilroy, California, 95020

  • Alliance Urology Specialists, PA

    Greensboro, North Carolina, 27403

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Virginia Oncology Associates

    Hampton, Virginia, 23666

  • Texas Oncology-Memorial City

    Houston, Texas, 77024

  • East Coast Institute for Research, LLC

    Jacksonville, Florida, 32207

  • East Coast Institute for Research, LLC

    Jacksonville, Florida, 32216

  • First Urology, PSC

    Jeffersonville, Indiana, 47130

  • Lancaster Urology

    Lancaster, Pennsylvania, 17604

  • Southern California Permanente Medical Group

    Los Angeles, California, 90027

  • Tower Urology

    Los Angeles, California, 90048

  • UCLA Clark Urology Clinic

    Los Angeles, California, 90095

  • UCLA Department of Pharmaceutical Services

    Los Angeles, California, 90095

  • University of Wisconsin Clinical Sciences Center

    Madison, Wisconsin, 53792

  • Kaiser Permanente Medical Center Lab Drawing Station

    Martinez, California, 94553

  • Metairie Oncologist, LLC

    Metairie, Louisiana, 70006

  • Kaiser Permanente Medical Center Lab Drawing Station

    Milpitas, California, 95035-5491

  • Kaiser Permanente Medical Center Lab Drawing Station

    Modesto, California, 95356

  • Kaiser Permanente Medical Center Lab Drawing Station

    Moutain View, California, 94041

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Kaiser Permanente Medical Center Lab Drawing Station

    Napa, California, 94558-3313

  • Specialists In Urology

    Naples, Florida, 34102

  • Urology Associates P.C.

    Nashville, Tennessee, 37209

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Kaiser Permanente Medical Center

    Oakland, California, 94611

  • GU Research network,LLC / Urology Cancer Center

    Omaha, Nebraska, 68130

  • Jefferson Medical Oncology

    Philadelphia, Pennsylvania, 19107

  • Jefferson Urology Associates

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • UPMC Cancer Center Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Kaiser Permanente Medical Center Lab Drawing Station

    Pleasanton, California, 94558

  • Premier Medical Group of the Hudson Valley PC

    Poughkeepsie, New York, 12601

  • Kaiser Permanente Medical Center Lab Drawing Station

    Redwood City, California, 94063

  • Kaiser Permanente Medical Center

    Roseville, California, 95661

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Kaiser Permanente Medical Center

    Sacramento, California, 95825

  • Salem Hospital

    Salem, Oregon, 97301

  • Rowan Regional Medical Center

    Salisbury, North Carolina, 28144

  • University of Utah/Huntsman Cancer Hospital

    Salt Lake City, Utah, 84112

  • University of Utah/Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Urology San Antonio Research

    San Antonio, Texas, 78229

  • San Bernardino Urological Associates Medical Group

    San Bernardino, California, 92404

  • Southern California Permanente Medical Group

    San Diego, California, 92120

  • Kaiser Permanente Medical Center

    San Francisco, California, 94115

  • Kaiser Permanente Medical Center

    San Jose, California, 95119

  • Kaiser Permanente Medical Center

    San Leandro, California, 94577

  • Southern California Permanente Medical Group

    San Marcos, California, 92078

  • Kaiser Permanente Medical Center

    Santa Clara, California, 95051

  • Desert Springs Cancer Care

    Scottsdale, Arizona, 85255

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Skyline Urology

    Sherman Oaks, California, 91411

  • Regional Urology, LLC

    Shreveport, Louisiana, 71106

  • Kaiser Permanente Medical Center

    South San Francisco, California, 94080

  • Oregon Urology Institute

    Springfield, Oregon, 97477

  • Sacred Heart Nuclear Medicine

    Springfield, Oregon, 97477

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Washington University Infusion Center Pharmacy

    St Louis, Missouri, 63110

  • Washington University, School of Medicine, 7th Floor, Center for Advanced Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129

  • Standford Health Care

    Stanford, California, 94305

  • Mount Nittany Physician Group

    State College, Pennsylvania, 16801

  • Mount Nittany Health

    State College, Pennsylvania, 16803

  • Associated Medical Professionals of NY, PLLC

    Syracuse, New York, 13210

  • Skyline Urology

    Torrance, California, 90505

  • Chesapeake Urology Research Associates

    Towson, Maryland, 21204

  • Michigan Institute of Urology

    Troy, Michigan, 48084

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85704

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85710

  • Urological Associates of Southern Arizona, PC

    Tucson, Arizona, 85715

  • Urological Associates of Southern Arizona, PC

    Tucson, Arizona, 85741

  • Kaiser Permanente Medical Center

    Vallejo, California, 94589

  • Urology of Virginia, PLLC.

    Virginia Beach, Virginia, 23462

  • Kaiser Permanente Medical Center

    Walnut Creek, California, 94596

  • George Washington University - Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Wake Forest Baptist Health Urology

    Winston-Salem, North Carolina, 27103

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

  • Minnesota Oncology Hematology, P.A.

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

Official title: STRIVE: A MULTICENTER PHASE 2, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE VS. BICALUTAMIDE IN MEN WITH PROSTATE CANCER WHO HAVE FAILED PRIMARY ANDROGEN DEPRIVATION THERAPY

The purpose of this study is to determine the safety and efficacy of enzalutamide vs bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have disease progression despite primary androgen deprivation therapy.

Read the detailed description

This study is a multicenter phase 2, randomized, double-blind, efficacy and safety study of enzalutamide (160 mg/day) vs. bicalutamide (50 mg/day) in patients with recurrent prostate cancer who have serologic and/or radiographic disease progression despite primary androgen deprivation therapy.

Throughout the study, safety and tolerability will be assessed by the recording of adverse events, monitoring of vital signs, physical examinations, and safety laboratory evaluations.

Following study unblinding, study patients receiving enzalutamide or bicalutamide at the time of unblinding and qualifying patients randomized to bicalutamide who discontinued prior to unblinding will be offered the opportunity to receive open label enzalutamide treatment.

Conditions
Prostate Cancer
Being tested
Enzalutamide, Bicalutamide
Keywords
prostate cancer, enzalutamide, MDV3100
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnzalutamideDrug

    Also called MDV3100, Xtandi

    160 mg, daily, by mouth.

  • BicalutamideDrug

    Also called Casodex

    50 mg, daily, by mouth

Study groups in NCT01664923
Study groupRoleWhat they receive
EnzalutamideExperimentalEnzalutamide 160 mg/day orally
Receives: Drug: Enzalutamide
BicalutamideActive comparator50 mg/day orally
Receives: Drug: Bicalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    PFS was defined as time from randomization to earliest objective evidence of prostate specific-antigen (PSA) progression, radiographic progression, or death on study. PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment. Radiographic progression in bone was based on The Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines defined as at least 2 new lesions on bone scan. Radiographic progression in soft tissue on Computerized Tomography/Magnetic Resonance Imaging (CT/MRI) was based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had a PFS event at the time of the analysis data cutoff were censored at the date of last assessment.

    Measured: From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.

Secondary outcomes (6)

  1. Time to PSA Progression

    PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment at least 3 weeks later. Participants not known to have had PSA progression were censored at the date of last PSA assessment.

    Measured: From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.

  2. Percentage of Participants With a PSA Response ≥ 50%

    PSA response was defined as a reduction in PSA of at least 50% from baseline at any post baseline assessment confirmed by a second PSA assessment at least 3 weeks later.

    Measured: From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.

  3. Duration of Radiographic PFS

    Duration of radiographic PFS was defined as the time from randomization to the earliest objective evidence of radiographic disease progression or death on study and was to be evaluated for participants with metastatic disease at study entry. Radiographic disease progression in bone was based on PCWG2 guidelines defined as at least 2 new lesions on bone scan. Radiographic disease progression in soft tissue on CT/MRI was based on RECIST 1.1. CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had radiographic progression at the time of analysis data cutoff were censored at the date of last radiographic assessment.

    Measured: From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.

  4. Quality of Life: Time to Degradation of Functional Assessment of Cancer Therapy - Prostate (FACT-P)

    The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess patient function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score (0 to 156) with higher scores representing better quality of life. Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation.

    Measured: From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.

  5. Best Overall Soft Tissue Response

    Best overall soft tissue response is defined as partial response (PR) or complete response (CR) while on study treatment based on investigator assessment of target, nontarget, and new lesions using RECIST 1.1. Only participants in the metastatic population with measurable soft tissue disease (at least 1 target lesion identified per RECIST 1.1) at screening were included in the analysis. All percentages are based on number of participants with metastatic and measurable soft tissue disease at screening in each treatment group.

    Measured: From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.

  6. Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. A treatment emergent AE defined as an event that emerged during treatment period (From first dose of study drug until end of open label phase [up to maximum duration of 65 months]) that was absent before treatment, or worsened during treatment period relative to pre-treatment state. AE included both serious and non- SAE. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An AE was considered related to study drug if event was assessed by investigator as probably or possibly related.

    Measured: From first dose of study drug until the end of open label phase (up to maximum duration of 65 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionFeb 2015
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
396 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01664923
Sponsor's protocol ID
MDV3100-09
Other IDs
C3431014
Acronym
STRIVE
Status last verified
Jan 2019
First submitted
10 Aug 2012
Last updated
30 Jan 2019
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Penson DF, Armstrong AJ, Concepcion RS, Agarwal N, Olsson CA, Karsh LI, Dunshee CJ, Duggan W, Shen Q, Sugg J, Haas GP, Higano CS. Enzalutamide versus bicalutamide in patients with nonmetastatic castration-resistant prostate cancer: a prespecified subgroup analysis of the STRIVE trial. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):363-365. doi: 10.1038/s41391-021-00465-7. Epub 2021 Oct 7.

    PubMed 34621011

  • Schultz NM, Shore ND, Chowdhury S, Klotz LH, Concepcion RS, Penson DF, Karsh LI, Yang H, Brown BA, Barlev A, Flanders SC. Number-needed-to-treat analysis of clinical progression in patients with metastatic castration-resistant prostate cancer in the STRIVE and TERRAIN trials. BMC Urol. 2018 Sep 6;18(1):77. doi: 10.1186/s12894-018-0387-7.

    PubMed 30189902

  • Penson DF, Armstrong AJ, Concepcion R, Agarwal N, Olsson C, Karsh L, Dunshee C, Wang F, Wu K, Krivoshik A, Phung D, Higano CS. Enzalutamide Versus Bicalutamide in Castration-Resistant Prostate Cancer: The STRIVE Trial. J Clin Oncol. 2016 Jun 20;34(18):2098-106. doi: 10.1200/JCO.2015.64.9285. Epub 2016 Jan 25.

    PubMed 26811535

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enzalutamide and Bicalutamide in people with Prostate Cancer, run by Pfizer at 109 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01664923, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.

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