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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Enzalutamide
Leuprolide acetate
radiation
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, enzalutamide, radiation, hormone therapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Enzalutamide, Leuprolide, radiation

Arm Description

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

Outcomes

Primary Outcome Measures

Safety, as Measured by the Number of Patients With at Least One Adverse Event as Assess by NCI Common Terminology Criteria for Adverse Events (CTCAE) vs. 40 When Combining Enzalutamide With a GnRH and External Beam Radiation
Assessment will number of participants who experience adverse events greater than or equal to Grade 3, as defined by NCI Common terminology criteria for adverse events(CTCAE) v4.0

Secondary Outcome Measures

Fold Change in Intra-tumoral Androgen Regulated Gene Expression Pre and Post Combination Therapy
Fold change of Intra-tumoral Androgen Regulated Gene Expression (PSA, FKBP5, TMPRSS2, and NDRG1) will be measure at 12 months post therapy.

Full Information

First Posted
February 10, 2014
Last Updated
September 17, 2020
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Astellas Pharma US, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02064582
Brief Title
Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
June 9, 2018 (Actual)
Study Completion Date
June 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Astellas Pharma US, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, enzalutamide, radiation, hormone therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enzalutamide, Leuprolide, radiation
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
Xtandi
Intervention Description
160mg by mouth each day
Intervention Type
Drug
Intervention Name(s)
Leuprolide acetate
Other Intervention Name(s)
Lupron
Intervention Description
22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months
Intervention Type
Radiation
Intervention Name(s)
radiation
Intervention Description
External beam radiation will be delivered as per standard radiation therapy protocol
Primary Outcome Measure Information:
Title
Safety, as Measured by the Number of Patients With at Least One Adverse Event as Assess by NCI Common Terminology Criteria for Adverse Events (CTCAE) vs. 40 When Combining Enzalutamide With a GnRH and External Beam Radiation
Description
Assessment will number of participants who experience adverse events greater than or equal to Grade 3, as defined by NCI Common terminology criteria for adverse events(CTCAE) v4.0
Time Frame
12 months following initiation of treatment with enzalutamide plus GnRH agonist
Secondary Outcome Measure Information:
Title
Fold Change in Intra-tumoral Androgen Regulated Gene Expression Pre and Post Combination Therapy
Description
Fold change of Intra-tumoral Androgen Regulated Gene Expression (PSA, FKBP5, TMPRSS2, and NDRG1) will be measure at 12 months post therapy.
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin D Courtney, MD, PhD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28191869
Citation
Li J, Alyamani M, Zhang A, Chang KH, Berk M, Li Z, Zhu Z, Petro M, Magi-Galluzzi C, Taplin ME, Garcia JA, Courtney K, Klein EA, Sharifi N. Aberrant corticosteroid metabolism in tumor cells enables GR takeover in enzalutamide resistant prostate cancer. Elife. 2017 Feb 13;6:e20183. doi: 10.7554/eLife.20183.
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Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer

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