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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064582
• Other study ID #: STU 082013-032
• Status: Completed
• Phase: Phase 2
• Start date: May 2014
• Est. completion date: June 9, 2018

Study information

• Verified date: September 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 9, 2018
• Est. primary completion date: June 9, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Enzalutamide
160mg by mouth each day
• Leuprolide acetate
22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months

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

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

References & 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. pii: e20183. doi: 10.7554/eLife.20183. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 months