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

NCT02023463 | Active Not Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: 13P.4612013-027JT 2970
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Acute toxicities, monitored using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 criteria

  An exact 2-sided binomial 90% confidence interval will be computed and reported. Toxicity will be monitored and if there is greater than 10% incidence of grade 3 or higher gastrointestinal (GI)/genitourinary (GU)/fatigue lasting more than 7 days despite optimal treatment, the trial will be re-evaluated.

  Up to 1 month post completion of enzalutamide

Secondary Outcomes (2)

• Change in PSA levels

  Baseline up to 6 months

• Quality of life (QoL), measured using the EPIC, AUA symptom index, and the PROMIS Fatigue Scale

  Baseline up to 1 year

Study Arms (1)

Treatment (enzalutamide, radiation therapy, hormone therapy)

EXPERIMENTAL

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.

Drug: Enzalutamide; Drug: Goserelin acetate; Drug: Leuprolide acetate; Radiation: Radiation therapy

Interventions

Enzalutamide DRUG

Given PO

Also known as: Xtandi, MDV3100

Treatment (enzalutamide, radiation therapy, hormone therapy)

Goserelin acetate DRUG

Given SC

Also known as: Goserelin, Zoladex

Treatment (enzalutamide, radiation therapy, hormone therapy)

Leuprolide acetate DRUG

Given IM or SC

Also known as: Leuprorelin, Leuprolide

Treatment (enzalutamide, radiation therapy, hormone therapy)

Radiation therapy RADIATION

Undergo image-guided radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation

Treatment (enzalutamide, radiation therapy, hormone therapy)

Eligibility Criteria

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

You may qualify if:

• Prostate adenocarcinoma without distant metastatic disease with either Gleason score ≥ 7, PSA ≥ 10 ng/ml, or T2b or greater disease
• Age \> 18
• Performance Status: ECOG 0-1
• Hematologic (minimal values):
• Absolute neutrophil count \> 1,500/mm3
• Hemoglobin \> 8.0 g/dl
• Platelet count \> 100,000/mm3
• 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
• Creatinine \< 1.5 x ULN
• Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

You may not qualify if:

• 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
• History of urological surgery or procedures predisposing to GU complications after radiation (will be determined by radiation oncologist)
• History of diverticulitis, rectal bleeding or other lower GI diseases predisposing to GI complications after radiation (will be determined by radiation oncologist)
• History of prior chemotherapy or pelvic irradiation,
• 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.
• Documented distant metastatic disease. NOTE: pelvic lymphadenopathy is NOT excluded.
• Prior radical prostatectomy or cryosurgery for prostate cancer or bilateral orchiectomy.
• No experimental medications within 30 days of study entry
• 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)

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Astellas Pharma Inc: collaborator
• Medivation, Inc.: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospitals

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzalutamide; Goserelin; Leuprolide; Radiotherapy; Radiation; Therapeutics

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

Study Officials

• Robert Den, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: December 30, 2013
• Study Start: April 2, 2014
• Primary Completion: July 10, 2017
• Study Completion (Estimated): January 1, 2040
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

US (1)