Study on Abiraterone Acetate, Niclosamide, and Prednisone for Treating Hormone-Resistant Prostate Cancer

Sponsor: Mamta Parikh

Sponsor score: 0

ClinicalTrials ID:NCT02807805

Provider View

This clinical trial is testing a combination of three drugs—abiraterone acetate, niclosamide, and prednisone—to see if they can effectively treat prostate cancer that no longer responds to hormone therapy. The study aims to understand the side effects and how well these drugs work together.

Patient Parameters

Program Overview

This study is exploring a treatment for prostate cancer that has become resistant to hormone therapy. The treatment involves three drugs: abiraterone acetate, which lowers androgen levels that can promote cancer growth; niclosamide, which may block other signals that help cancer cells grow; and prednisone, which reduces inflammation. The goal is to see if this combination can better manage hormone-resistant prostate cancer.

Description

The main goal of this study is to see if the combination of abiraterone acetate, niclosamide, and prednisone can reduce prostate-specific antigen (PSA) levels by 50% or more from the start of the treatment. Researchers will also look at how the cancer responds overall, how long patients live without the cancer getting worse, and any side effects from the treatment.

Patients will take abiraterone acetate once a day, niclosamide twice a day, and prednisone twice a day. This cycle will repeat every four weeks as long as the cancer does not progress and side effects are manageable. After finishing the treatment, patients will be monitored for three months.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed prostate cancer, either recurring after surgery or radiation, or metastatic.
  • Cancer must be resistant to hormone therapy, shown by disease progression or rising PSA levels despite treatment.
  • No need for measurable disease, but if present, must be assessed within 28 days before starting the study.
  • Must have been medically or surgically castrated, with testosterone levels below 50 ng/dL.
  • Must be in good general health with a performance status of 0 to 2.
  • Life expectancy of more than 6 months.
  • Must have adequate blood cell counts and organ function.
  • Men must agree to use contraception during the study and for 4 months after.
  • Must understand and agree to the study by signing a consent form.

Exclusion Criteria

  • Cannot have had chemotherapy or radiotherapy within 4 weeks before starting the study.
  • Cannot be taking other experimental drugs or alternative medicines for prostate cancer.
  • Cannot have previously taken abiraterone or ketoconazole for prostate cancer.
  • Cannot have other cancers within the past 3 years, except for certain skin cancers or early-stage cancers.
  • Cannot have known brain metastases.
  • Cannot have allergies to similar drugs.
  • Cannot have uncontrolled illnesses or infections.
  • Cannot be HIV-positive and on antiretroviral therapy.
  • Cannot have gastrointestinal issues that affect drug absorption.
  • Cannot have active bleeding disorders.
  • Must be willing and able to follow the study protocol.

Locations

FACILITYZIPCITYSTATE
University of California Davis Comprehensive Cancer Center95817SacramentoCalifornia

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