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

NCT02064582 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: STU 082013-032
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer, enzalutamide, radiation, hormone therapy

Outcome Measures

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

  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

  12 months following initiation of treatment with enzalutamide plus GnRH agonist

Secondary Outcomes (1)

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

  12 months

Study Arms (1)

Enzalutamide, Leuprolide, radiation

OTHER

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; Drug: Leuprolide acetate; Radiation: radiation

Interventions

Enzalutamide DRUG

160mg by mouth each day

Also known as: Xtandi

Enzalutamide, Leuprolide, radiation

Leuprolide acetate DRUG

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

Also known as: Lupron

Enzalutamide, Leuprolide, radiation

radiation RADIATION

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

Enzalutamide, Leuprolide, radiation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• 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.

  PMID: 28191869 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzalutamide; Leuprolide; Radiation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Physical Phenomena

Results Point of Contact

• Title: Kevin Courtney, MD
• Organization: UT Southwestern Medical Center

Kevin.Courtney@utsouthwestern.edu

214-648-4180

Study Officials

• Kevin D Courtney, MD, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 17, 2014
• Study Start: May 1, 2014
• Primary Completion: June 9, 2018
• Study Completion: June 9, 2018
• Last Updated: October 12, 2020
• Results First Posted: October 12, 2020

Record last verified: 2020-09

Locations

US (1)