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Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02064582
Recruitment Status : Active, not recruiting
First Posted : February 17, 2014
Last Update Posted : May 15, 2018
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
The study is being done to find out whether combining two FDA approved drugs along with radiation therapy for the treatment of high risk localized prostate cancer is safe and well tolerated.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Enzalutamide Drug: Leuprolide acetate Radiation: radiation Phase 2

Detailed Description:
  • this pilot study will assess the safety and tolerability of combining enzalutamide with an gonadotropin-releasing hormone agonist (GnRH) and external beam radiation
  • Correlative imaging and tissue biopsy analysis will be performed to assess the radiographic response to enzalutamide plus gonadotropin-releasing hormone agonist (GnRH) therapy as well as intratumoral androgen signaling

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Enzalutamide and GnRH Agonist Before, During and After Radiation Therapy in Treatment of Patients With High-risk Localized Prostate Cancer
Actual Study Start Date : May 2014
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Enzalutamide, Leuprolide, radiation
Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care
Drug: Enzalutamide
160mg by mouth each day
Other Name: Xtandi

Drug: Leuprolide acetate
22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months
Other Name: Lupron

Radiation: radiation
External beam radiation will be delivered as per standard radiation therapy protocol




Primary Outcome Measures :
  1. Assess the safety and tolerability of combining enzalutamide with a GnRH and external beam radiation [ Time Frame: 12 months ]
    Assessment will be based on the rate of drug related grade 1-5 adverse events experienced within the first 12 months of study treatment via NCI Common terminology criteria for adverse events(CTCAE) v4.0


Secondary Outcome Measures :
  1. Assess intra-tumoral androgen regulated gene expression pre and post combination therapy [ Time Frame: 12 months ]
    tumor gene expression will be analyzed on tissue samples pre and post therapy



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically proven adenocarcinoma of the prostate within 6 months of screening
  • Eastern Cooperative Oncology Group(ECOG) score 0-2
  • adequate organ and and blood marrow function
  • must be a candidate for long-term androgen deprivation in combination with external beam radiation for the treatment of high risk prostate cancer
  • patient must permit a targeted prostate biopsy at the time of study initiation or at the beginning of radiation treatment
  • men who are sexually active with female partners of child-bearing potential mush agree to use adequate contraception

Exclusion Criteria:

  • prior treatment with agents known to have endocrine effects on prostate cancer
  • treatment with corticosteroids within 4 weeks of enrollment
  • treatment with androgens within 6 months of enrollment
  • may not be receiving any other investigational agents
  • Prostate specific antigen greater than 160ng/dL
  • history of malignancy( other than non-melanoma skin cancer) within 5 years
  • uncontrolled intercurrent illness
  • cardiovascular event within 6 months of enrollment
  • seizure or seizure disorder history
  • contraindications to MRI- pacemakers, clips, etc

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): NCT02064582


Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Kevin D Courtney, MD, PhD UT Southwestern Medical Center

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02064582     History of Changes
Other Study ID Numbers: STU 082013-032
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Keywords provided by University of Texas Southwestern Medical Center:
prostate cancer, enzalutamide, radiation, hormone therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents