RECRUITING

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.

Official Title

A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Quick Facts

Study Start:2016-12-22
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02960022

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject must currently be receiving enzalutamide for prostate cancer in a study sponsored by Astellas or Medivation and, based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.
  2. * Subject is able to continue on the treatment regimen that the subject was receiving in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dose change in Androgen deprivation therapy (ADT) or dropping of a combination therapy) approval from a medical monitor is required prior to enrollment.
  3. * Subject is able to swallow enzalutamide capsules and comply with study requirements.
  4. * Subject and female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective and 1 must be a barrier method throughout the study and for 3 months after final enzalutamide administration.
  5. * Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.
  6. * Subject agrees not to participate in another interventional study while on treatment.
  7. * Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act authorization for the United States sites) must be obtained from the subject prior to any study-related procedures.
  8. * Subject must currently be receiving enzalutamide for breast cancer in a study sponsored by Astellas or Medivation/Pfizer and based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.
  9. * Subject is able to continue on the treatment regimen that they were receiving in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dropping of a combination therapy) approval from a medical monitor is required prior to enrollment.
  10. * Subject is able to swallow enzalutamide capsules and comply with study requirements.
  11. * Subject is either:
  12. * Of nonchildbearing potential:
  13. * postmenopausal (defined as no spontaneous menses for at least 12 months prior to Day 1 with follicle stimulating hormone (FSH) \> 40 IU/L at Day 1 for women \< 55 years of age),
  14. * documented surgically sterile or status post hysterectomy (at least 1 month prior to Day 1),
  15. * Or, if of childbearing potential,
  16. * must have a negative urine pregnancy test at Day 1 before the first dose of study drug is administered,
  17. * must use 2 acceptable methods of birth control starting at Day 1 and through 6 months after the final study drug administration,
  18. * must not donate ova starting at first administration of study intervention and throughout 6 months after final study intervention administration.
  19. * A barrier method (e.g., condom by a male partner) is required; AND
  20. * One of the following is required:
  21. * Placement of an intrauterine device (IUD) or intrauterine system (IUS);
  22. * Additional barrier method including occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;
  23. * Vasectomy or other surgical castration at least 6 months before Day 1.
  24. * The subject must not be breastfeeding at Day 1 or during the study period, and for 6 months after the final study drug administration.
  25. * Subject agrees not to participate in another interventional study while on treatment.
  1. * Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which subject is enrolling from.
  2. * Subject requires treatment with or plans to use either of the following:
  3. * New systemic therapy for subjects cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment.
  4. * Investigational therapy other than enzalutamide.
  5. * Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
  6. * Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.
  7. * Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which they are enrolling from.
  8. * Subject requires treatment with or plans to use any of the following:
  9. * New systemic therapy for their cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment.
  10. * Investigational therapy other than enzalutamide.
  11. * Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
  12. * Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data in the opinion of the investigator.

Contacts and Locations

Study Contact

Astellas Pharma Global Development
CONTACT
800-888-7704
astellas.registration@astellas.com

Principal Investigator

Associate Medical Director
STUDY_DIRECTOR
Astellas Pharma Global Development, Inc.

Study Locations (Sites)

Site US10052
Anchorage, Alaska, 99503
United States
Site US10011
Tucson, Arizona, 85741
United States
Site US10040
Los Angeles, California, 90024
United States
Site US10009
Los Angeles, California, 90048
United States
Site US10067
Orange, California, 92868
United States
Site US10008
San Bernardino, California, 92404
United States
Site US10042
San Diego, California, 92108
United States
Site US10028
Stanford, California, 94305
United States
Site US10001
Aurora, Colorado, 80045
United States
Site US10017
Denver, Colorado, 80211
United States
Site US10050
Washington, District of Columbia, 20037
United States
Site US10049
Daytona Beach, Florida, 32114
United States
Site US10048
Jacksonville, Florida, 32216
United States
Site US10002
Chicago, Illinois, 60637
United States
Springfield Clinic, LLP
Springfield, Illinois, 62701
United States
Site US10007
Jeffersonville, Indiana, 47130
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Site US10066
Lenexa, Kansas, 66214-1656
United States
Site US10029
Towson, Maryland, 21204
United States
Site US10032
Saint Louis, Missouri, 63110
United States
Nebraska Medical Hospital
Omaha, Nebraska, 68114
United States
Site US10023
Omaha, Nebraska, 68130
United States
Site US10004
Hackensack, New Jersey, 07601
United States
Site US10024
Garden City, New York, 11530
United States
Site US10055
New York, New York, 10065
United States
Site US10059
New York, New York, 10065
United States
Hudson Valley Urology, PC
Poughkeepsie, New York, 12601
United States
Site US10053
Syracuse, New York, 13210
United States
Site US10030
Chapel Hill, North Carolina, 27599
United States
Site US10062
Charlotte, North Carolina, 28207
United States
Site US10020
Concord, North Carolina, 28025
United States
Site US10031
Greensboro, North Carolina, 27403
United States
Eastern Urological Associates
Greenville, North Carolina, 27834
United States
Site US10046
Winston-Salem, North Carolina, 27157
United States
Site US10035
Cincinnati, Ohio, 45212
United States
Site US10022
Springfield, Oregon, 97477
United States
Site US10027
Lancaster, Pennsylvania, 17604
United States
Site US10005
Pittsburgh, Pennsylvania, 15232
United States
Site US10018
Charleston, South Carolina, 29414
United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
United States
Site US10003
Myrtle Beach, South Carolina, 29572
United States
Site US10041
Nashville, Tennessee, 37232-2765
United States
Site US10010
Dallas, Texas, 75231
United States
Site US10034
Houston, Texas, 77024
United States
Site US10043
Houston, Texas, 77030
United States
Site US10014
Norfolk, Virginia, 23502
United States
Site US10015
Virginia Beach, Virginia, 23462
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States
Site US10038
Seattle, Washington, 98109
United States
Site US10021
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Astellas Pharma Global Development, Inc.

  • Associate Medical Director, STUDY_DIRECTOR, Astellas Pharma Global Development, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-12-22
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2016-12-22
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • prostate cancer
  • prednisone
  • MDV3100
  • enzalutamide
  • Xtandi
  • abiraterone acetate

Additional Relevant MeSH Terms

  • Prostate Cancer