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

The University of Texas System (UT)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Radiation: radiation; Drug: Leuprolide acetate; Drug: Enzalutamide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02064582

STU 082013-032

Details and patient eligibility

About

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.

Full 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

Enrollment: 7 patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Enzalutamide, Leuprolide, radiation

Other group

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

Treatment:

Radiation: radiation

Drug: Enzalutamide

Drug: Leuprolide acetate