Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer

NCT ID: NCT02023463

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-02
• Study Completion Date: 2040-01-01

Brief Summary

This phase I trial studies the side effects and best way to give enzalutamide, radiation therapy, and hormone therapy in treating patients with intermediate or high-risk prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as enzalutamide, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. Giving enzalutamide, radiation therapy, and hormone therapy may be an effective treatment for prostate cancer.

Detailed Description

PRIMARY OBJECTIVE:

1) To assess the safety of the combination of neoadjuvant and concurrent enzalutamide with an luteinizing-hormone-releasing hormone (LHRH) agonist and radiation therapy.

SECONDARY OBJECTIVES:

1. To determine the efficacy of the combination of enzalutamide with an LHRH agonist and radiation therapy using prostate specific antigen (PSA) kinetics.

2. To determine the efficacy of the combination of enzalutamide with an LHRH agonist and radiation therapy using PSA nadir.

3. To describe patient-reported outcomes including: Expanded Prostate Cancer Index Composite (EPIC), American Urological Association (AUA) Symptom Index, PROstate magnetic resonance (MR) Imaging Study (PROMIS) Fatigue Scale.

OUTLINE:

Patients receive enzalutamide orally (PO) once daily (QD) for 6 months. Beginning 2 weeks after start of enzalutamide, patients receive LHRH agonist therapy with goserelin acetate subcutaneously (SC) or leuprolide acetate intramuscularly (IM) or SC for 6 months (intermediate risk patients) or 24 months (high risk patients) post-radiation therapy. Beginning 8 weeks after the start of LHRH agonist therapy, patients undergo either intensity modulated radiation therapy (IMRT) or volumetric arc therapy (VMAT) daily five days a week for 8 weeks.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

Conditions

Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (enzalutamide, radiation therapy, hormone therapy)

Patients receive enzalutamide PO QD for 6 months. Beginning 2 weeks after start of enzalutamide, patients receive LHRH agonist therapy with goserelin acetate SC or leuprolide acetate IM or SC for 6 months (intermediate risk patients) or 24 months (high risk patients) post-radiation therapy. Beginning 8 weeks after the start of LHRH therapy, patients undergo either IMRT or VMAT daily five days a week for 8 weeks.

Group Type: EXPERIMENTAL

Enzalutamide

Intervention Type: DRUG

Given PO

Goserelin acetate

Intervention Type: DRUG

Given SC

Leuprolide acetate

Intervention Type: DRUG

Given IM or SC

Radiation therapy

Intervention Type: RADIATION

Undergo image-guided radiation therapy

Interventions

Enzalutamide

Given PO

Intervention Type: DRUG

Goserelin acetate

Given SC

Intervention Type: DRUG

Leuprolide acetate

Given IM or SC

Intervention Type: DRUG

Radiation therapy

Undergo image-guided radiation therapy

Intervention Type: RADIATION

Other Intervention Names

Xtandi; MDV3100; Goserelin; Zoladex; Leuprorelin; Leuprolide; irradiation; radiotherapy; therapy; radiation

Eligibility Criteria

Inclusion Criteria

1. Prostate adenocarcinoma without distant metastatic disease with either Gleason score ≥ 7, PSA ≥ 10 ng/ml, or T2b or greater disease

2. Age > 18

3. Performance Status: ECOG 0-1

4. Hematologic (minimal values):

• Absolute neutrophil count > 1,500/mm3
• Hemoglobin > 8.0 g/dl
• Platelet count > 100,000/mm3

5. Hepatic function

• Total bilirubin < Upper limit of normal (ULN)(except for Gilbert's disease)
• AST (SGOT) < 1.5 x ULN
• ALT (SGPT) < 1.5 x ULN

6. Creatinine < 1.5 x ULN

7. Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

Exclusion Criteria

1. Patients with a history of seizure, underlying brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain metastases, brain arteriovenous malformation or the use of concomitant medications that may lower the seizure threshold

2. History of urological surgery or procedures predisposing to GU complications after radiation (will be determined by radiation oncologist)

3. History of diverticulitis, rectal bleeding or other lower GI diseases predisposing to GI complications after radiation (will be determined by radiation oncologist)

4. History of prior chemotherapy or pelvic irradiation,

5. History of prior invasive malignant cancer(s) within the last 5 years except adequately treated or controlled basal cell or squamous cell carcinoma of the skin.

6. Documented distant metastatic disease. NOTE: pelvic lymphadenopathy is NOT excluded.

7. Prior radical prostatectomy or cryosurgery for prostate cancer or bilateral orchiectomy.

8. No experimental medications within 30 days of study entry

9. Patients currently taking the following medications:

• CYP2C8 inhibitors (e.g. Gemfibrozil)
• CYP2C8 inducers (e.g. rifampin)
• CYP3A4 inhibitors (itraconazole)
• CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: collaborator

Medivation, Inc.

INDUSTRY

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Den, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Related Links

http://www.JeffersonHospital.org

Thomas Jefferson University Hospitals

Other Identifiers

2013-027

Identifier Type: OTHER

Identifier Source: secondary_id

JT 2970

Identifier Type: OTHER

Identifier Source: secondary_id

13P.461

Identifier Type: -

Identifier Source: org_study_id