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Antiandrogen Therapy, Abiraterone Acetate, and Prednisone With or Without Neutron Radiation Therapy in Treating Patients With Prostate Cancer

NCT03649841 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-10-26

Study results available
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Summary

This phase II trial studies how well antiandrogen therapy, abiraterone acetate, and prednisone with or without neutron radiation therapy work in treating patients with prostate cancer. Hormone therapy such as antiandrogen therapy may fight prostate cancer by blocking the production and interfering with the action of hormones. Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Neutron radiation therapy uses high energy neutrons to kill tumor cells and shrink tumors. It is not yet known whether antiandrogen therapy, abiraterone acetate, and prednisone with or without neutron radiation therapy may work better in treating patients with prostate cancer.

Conditions

  • Castration-Sensitive Prostate Carcinoma
  • Metastatic Malignant Neoplasm in the Bone
  • Metastatic Prostate Carcinoma
  • Prostate Adenocarcinoma
  • Prostate Small Cell Neuroendocrine Carcinoma
  • Stage IV Prostate Cancer AJCC v8
  • Stage IVA Prostate Cancer AJCC v8
  • Stage IVB Prostate Cancer AJCC v8

Interventions

DRUG

Antiandrogen Therapy

Undergo ADT

DRUG

Abiraterone Acetate

Undergo Abiraterone Acetate Treatment SOC

DRUG

Prednisone

Undergo Prednisone Treatment SOC

RADIATION

Radiation Therapy

Undergo neutron radiation therapy

Sponsors & Collaborators

Principal Investigators

  • Jing Zeng · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-29
Primary Completion
2022-09-01
Completion
2023-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03649841 on ClinicalTrials.gov