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Apalutamide, Abiraterone Acetate, and Prednisone for the Treatment of Metastatic High Risk Castration Sensitive Prostate Cancer

2020-02-17 18:20:54 | BioPortfolio

Summary

This phase II trial studies how well apalutamide, abiraterone acetate, and prednisone after chemotherapy work in treating patients with high risk prostate cancer that is sensitive to androgen deprivation therapy (castration sensitive) and has spread to other parts of the body (metastatic). Testosterone can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Antihormone therapy, such as abiraterone acetate, may lessen the amount of testosterone made by the body. 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. Apalutamide, abiraterone acetate, and prednisone after chemotherapy may work better in treating patients with castration sensitive prostate cancer.

Description

PRIMARY OBJECTIVE:

I. Efficacy of apalutamide in combination with abiraterone acetate + prednisone following docetaxel with ongoing androgen deprivation therapy in men with high risk metastatic castration sensitive disease.

SECONDARY OBJECTIVES:

I. Safety and tolerability of apalutamide in combination with abiraterone acetate + prednisone following docetaxel with ongoing androgen deprivation therapy.

II. Time to event. III. Rate of conversion from AR-V7 negative to positive. IV. Depth of prostate specific antigen (PSA) response.

EXPLORATORY OBJECTIVES:

I. Quality of life. II. Falls.

OUTLINE:

Patients receive apalutamide orally (PO) once daily (QD), abiraterone acetate PO QD, and prednisone PO QD. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive androgen deprivation therapy per standard of care.

After completion of study treatment, patients are followed up every 6 months for up to 10 years.

Study Design

Conditions

Castration-Sensitive Prostate Carcinoma

Intervention

Abiraterone Acetate, Antiandrogen Therapy, Apalutamide, Prednisone, Quality-of-Life Assessment, Questionnaire Administration

Location

OHSU Knight Cancer Institute
Portland
Oregon
United States
97239

Status

Not yet recruiting

Source

OHSU Knight Cancer Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-02-17T18:20:54-0500

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Medical and Biotech [MESH] Definitions

An androstene derivative that inhibits STEROID 17-ALPHA-HYDROXYLASE and is used as an ANTINEOPLASTIC AGENT in the treatment of metastatic castration-resistant PROSTATE CANCER.

Megestrol acetate is a progestogen with actions and uses similar to those of the progestogens in general. It also has anti-androgenic properties. It is given by mouth in the palliative treatment or as an adjunct to other therapy in endometrial carcinoma and in breast cancer. Megestrol acetate has been approved to treat anorexia and cachexia. (From Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)

A measurement index derived from a modification of standard life-table procedures and designed to take account of the quality as well as the duration of survival. This index can be used in assessing the outcome of health care procedures or services. (BIOETHICS Thesaurus, 1994)

A form of therapy that employs a coordinated and interdisciplinary approach for easing the suffering and improving the quality of life of those experiencing pain.

A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral and social environment; the overall condition of a human life.

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