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Abiraterone Acetate, Prednisone, and Leuprolide Acetate or Goserelin Before and During Radiation Therapy in Treating Patients With Localized or Locally Advanced Prostate Cancer

2014-08-27 03:17:38 | BioPortfolio

Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate, leuprolide acetate, and goserelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving abiraterone acetate and leuprolide acetate or goserelin before or together with radiation therapy may be an effective treatment for prostate cancer.

PURPOSE: This phase II trial is studying the side effects and how well giving abiraterone acetate, prednisone, and leuprolide acetate or goserelin before and during radiation therapy works in treating patients with localized or locally advanced prostate cancer.

Description

PRIMARY OBJECTIVES:

I. To evaluate the safety of abiraterone and prednisone with LHRH agonist given as neoadjuvant and concurrent therapy with external beam radiation in patients with localized prostate cancer.

II. To determine whether pharmacologic suppression of the prostatic androgen axis by inhibition of androgen production with abiraterone can decrease tissue androgen levels to below those observed with GnRH agonist suppression of testicular androgens.

SECONDARY OBJECTIVES:

I. To determine whether treatment with abiraterone acetate with LHRH agonist will be more effective than LHRH agonist with bicalutamide in inducing inhibition of androgen-regulated gene expression and increased apoptotic cell death as assessed by immunohistochemisty, cDNA microarray analysis and RT-PCR.

II. To evaluate time to PSA progression in patients treated with LHRH agonist with abiraterone acetate.

OUTLINE: Patients receive oral abiraterone acetate and oral prednisone once daily for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 5 years.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

abiraterone acetate, prednisone, leuprolide acetate, mass spectrometry, laboratory biomarker analysis, immunohistochemistry staining method, microarray analysis, reverse transcriptase-polymerase chain reaction, external beam radiation therapy, goserelin

Location

University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami
Florida
United States
33136

Status

Recruiting

Source

Fred Hutchinson Cancer Research Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:38-0400

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PubMed Articles [9712 Associated PubMed Articles listed on BioPortfolio]

The IMAAGEN Study: Effect of Abiraterone Acetate and Prednisone on Prostate-Specific Antigen and Radiographic Disease Progression in Patients with Non-Metastatic Castration-Resistant Prostate Cancer.

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Medical and Biotech [MESH] Definitions

A mass spectrometry technique using two (MS/MS) or more mass analyzers. With two in tandem, the precursor ions are mass-selected by a first mass analyzer, and focused into a collision region where they are then fragmented into product ions which are then characterized by a second mass analyzer. A variety of techniques are used to separate the compounds, ionize them, and introduce them to the first mass analyzer. For example, for in GC-MS/MS, GAS CHROMATOGRAPHY-MASS SPECTROMETRY is involved in separating relatively small compounds by GAS CHROMATOGRAPHY prior to injecting them into an ionization chamber for the mass selection.

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.

An enzyme that catalyzes the conversion of acetate esters and water to alcohols and acetate. EC 3.1.1.6.

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 6-methyl PROGESTERONE acetate with reported glucocorticoid activity and effect on ESTRUS.

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Prostate cancer (cancer de prostata) Prostate cancer (cancer de prostata) is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostat...


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