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Hormone Therapy in Treating Patients Who Have Stage I or Stage II Prostate Cancer

2014-07-24 14:35:57 | BioPortfolio

Summary

RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of testosterone. It is not yet known whether receiving leuprolide and flutamide is more effective than receiving no further therapy.

PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in treating patients who have stage I or stage II prostate cancer that is at high risk of recurrence and who have already undergone surgery.

Description

OBJECTIVES:

- Determine the effect of one year of adjuvant hormonal ablation on disease-free survival at 5 years in node-negative radical prostatectomy patients at high risk for progression.

- Determine the effect of this treatment on the incidence of androgen independent prostate cancer and on disease specific and overall survival.

- Determine the impact of one year of total androgen ablation on quality of life and serum testosterone levels.

- Assess differences in quality of life between wives of patients in the androgen ablation condition compared to wives of patients in the control condition.

- Obtain blood samples from patients at high risk for failure post-prostatectomy to evaluate serum markers of prognosis.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

- Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year.

- Arm II: Patients receive no initial treatment. Quality of life is assessed every 6 months for 5 years. Quality of life of wives/partners of patients is assessed every 6 months for two years.

Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 496 patients (248 per treatment arm) will be accrued for this study within 3.5 years.

Study Design

Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

flutamide, leuprolide acetate

Location

University of Texas - MD Anderson Cancer Center
Houston
Texas
United States
77030-4009

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:35:57-0400

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Neoadjuvant Abiraterone Acetate Plus Leuprolide Acetate in Men With Localized High Risk Prostate Cancer

The purpose of this research study is to determine the effects of abiraterone acetate plus leuprolide acetate and prednisone versus leuprolide acetate alone on hormone levels in the blood ...

Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer

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A Study of Leuprolide 45 mg Formulation to Treat Prostate Cancer

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PubMed Articles [14263 Associated PubMed Articles listed on BioPortfolio]

Clinical Outcomes of First-line Abiraterone Acetate or Enzalutamide for Metastatic Castration-resistant Prostate Cancer After Androgen Deprivation Therapy + Docetaxel or ADT Alone for Metastatic Hormone-sensitive Prostate Cancer.

The CHAARTED (ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer) and STAMPEDE (Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evalu...

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.

To evaluate the use of abiraterone acetate (1000 mg) plus prednisone (5mg) [AA+P] in patients with high-risk non-metastatic castration resistant prostate cancer (nmCRPC).

Radioligand therapy of metastatic castration-resistant prostate cancer: current approaches.

Prostate Cancer is the forth most common type of cancer. Prostate-specific membrane antigen (PSMA) is anchored in the cell membrane of prostate epithelial cells. PSMA is highly expressed on prostate e...

Developing new age-specific prostate-specific antigen thresholds for testing for prostate cancer.

To examine whether age-related reference ranges for "normal" prostate-specific antigen (PSA) change (determined in men without prostate cancer) can be used to identify men at high risk of having prost...

The Role of Testosterone Therapy in the Setting of Prostate Cancer.

The role of testosterone in the development of prostate cancer and the safety of testosterone therapy (TTh) after prostate cancer treatment, or in the setting of active surveillance, remains controver...

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.

A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of 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)

17-Hydroxy-6-methylpregna-3,6-diene-3,20-dione. A progestational hormone used most commonly as the acetate ester. As the acetate, it is more potent than progesterone both as a progestagen and as an ovulation inhibitor. It has also been used in the palliative treatment of breast cancer.

A synthetic retinoid that is used orally as a chemopreventive against prostate cancer and in women at risk of developing contralateral breast cancer. It is also effective as an antineoplastic agent.

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