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Completed

NCT Number: NCT02064582

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enzalutamide

Drug

160mg by mouth each day

Other names: Xtandi

Leuprolide Acetate

Drug

22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months

Other names: Lupron

Radiation

Radiation

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

Primary outcomes

  1. 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

    Time frame: 12 months following initiation of treatment with enzalutamide plus GnRH agonist

    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 outcomes

  1. Fold Change in Intra-tumoral Androgen Regulated Gene Expression Pre and Post Combination Therapy

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Astellas Pharma US, Inc.

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 17, 2014
Registry last updated
Oct 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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