NCT02508636

Trial of Radiotherapy With Leuprolide and Enzalutamide in High Risk Prostate Cancer

Phase II Trial of Definitive Radiotherapy With Leuprolide and Enzalutamide in High Risk Prostate Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the safety of giving enzalutamide with leuprolide acetate before and after radiation therapy and to see how well it works in treating patients with prostate cancer that is at high risk of returning. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Most types of prostate cancer also need testosterone to grow and spread. After radiation therapy, patients often receive treatments to reduce testosterone to prevent the cancer from returning. Leuprolide acetate works by reducing the amount of testosterone that the body makes. Enzalutamide is a stronger treatment that may block testosterone from reaching cancer cells. Adding enzalutamide to treatment with leuprolide acetate after radiation therapy may help prevent high-risk prostate cancer from returning and improve patient survival.

Detailed description

PRIMARY OBJECTIVES: I. To determine the feasibility and safety of the combination of enzalutamide and leuprolide acetate (leuprolide) in patients undergoing definitive radiation therapy for high-risk prostate cancer or with pelvic nodal involvement. II. To determine the prostate-specific antigen (PSA) complete response rate with the combination of enzalutamide and leuprolide (PSA-complete response (CR) as determined by PSA nadir =\< 0.3) in patients undergoing radiation therapy for high-risk prostate cancer or pelvic nodal involvement. SECONDARY OBJECTIVES: I. To determine time to biochemical failure as determined by the American Society for Radiation Oncology (ASTRO) Phoenix definition of nadir + 2 ng/mL, local progression, regional progression, and distant metastases. II. To determine time to clinical progression free survival III. To assess changes in PSA nadir and PSA and testosterone levels. IV. To assess changes in hemoglobin A1c (HbA1c), fasting glucose, fasting insulin and fasting lipid and cholesterol levels. V. To document changes in quality of life outcomes. EXPLORATORY OBJECTIVES: I. To identify potential mutations and changes gene copy number associated with enzalutamide resistance in patients with high risk prostate cancer. II. To identify gene expression patterns, splice variants, and gene signatures associated with enzalutamide treatment and enzalutamide resistance in patients with high risk prostate cancer. III. To identify changes in the immune response with enzalutamide treatment. OUTLINE: Patients receive enzalutamide orally (PO) once daily (QD) and leuprolide acetate intramuscularly (IM) every 1, 3, 4, or 6 months for 24 months. Patients also undergo standard of care intensity-modulated radiation therapy (IMRT) 5 days per week for 5 weeks beginning at week 8, followed by optional brachytherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 6 weeks, 3-4 months, 6, 12, 18, 24, and 36 months.

Conditions

• Prostatic Neoplasms
• Pelvic Nodal

Interventions

Type	Name	Description
DRUG	Enzalutamide	Given orally
DRUG	Leuprolide	Given via intramuscular injection
RADIATION	Intensity-Modulated Radiation Therapy	A total dose of 45 Gy in 25 fractions of 1.8 Gy each.

Timeline

• Start date: 2015-12-22
• Primary completion: 2020-08-31
• Completion: 2020-08-31
• First posted: 2015-07-27
• Last updated: 2021-10-12
• Results posted: 2021-10-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study