NCT02472275

PLX3397, Radiation Therapy, and Antihormone Therapy in Treating Patients With Intermediate- or High-Risk Prostate Cancer

Targeting the Prostatic Tumor Microenvironment With PLX3397, a Tumor-Associated Macrophage Inhibitor in Men With Unfavorable Risk Prostate Cancer Undergoing Radiation Therapy and Androgen Deprivation Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of multitargeted tyrosine kinase inhibitor PLX3397 (PLX3397) when given together with radiation therapy and antihormone therapy in treating patients with prostate cancer that is at intermediate or high risk of spreading. Multitargeted tyrosine kinase inhibitor PLX3397 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may also help the radiation therapy work better. Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin acetate, or degarelix, may lessen the amount of androgens made by the body. Giving multitargeted tyrosine kinase inhibitor PLX3397 with radiation therapy and antihormone therapy may be a better treatment for prostate cancer.

Detailed description

PRIMARY OBJECTIVES: I. To conduct a phase I, dose escalation trial with a primary objective of establishing the maximum tolerated dose (MTD) and the dose limiting toxicity (DLT). SECONDARY OBJECTIVES: I. To assess the effects of radiation therapy (RT), androgen deprivation therapy (ADT), and PLX3397 (at its MTD) on tumor-associated macrophages (TAMs) in the prostate biopsy after treatment. OUTLINE: This is a dose-escalation study of multitargeted tyrosine kinase inhibitor PLX3397. Patients receive multitargeted tyrosine kinase inhibitor PLX3397 orally (PO) twice daily (BID) for 6 months, undergo radiation therapy for 2 months daily (Monday-Friday) beginning at month 3, and undergo ADT with leuprolide acetate, goserelin acetate, or degarelix injections in any month. After completion of study treatment, patients are followed up at 20-30 days and then every 12 weeks thereafter.

Conditions

• Stage I Prostate Adenocarcinoma
• Stage II Prostate Adenocarcinoma
• Stage III Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Antiandrogen Therapy	Undergo ADT with leuprolide acetate, goserelin acetate, or degarelix
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Multitargeted Tyrosine Kinase Inhibitor PLX3397	Given PO
RADIATION	Radiation Therapy	Undergo radiation therapy

Timeline

• Start date: 2015-06-01
• Primary completion: 2019-08-05
• Completion: 2019-08-05
• First posted: 2015-06-15
• Last updated: 2020-10-06

Locations

3 sites across 1 country: United States