Advertisement

Topics

Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate

2014-08-27 03:54:32 | BioPortfolio

Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent or delay the development of early cancer. Soy isoflavones may be effective in delaying the development of early prostate cancer.

PURPOSE: This randomized phase II trial is studying different regimens of soy isoflavones to compare how well they work in treating patients who are undergoing radical prostatectomy for stage I or stage II prostate cancer (adenocarcinoma).

Description

OBJECTIVES:

- Compare blood/prostate biomarkers of oxidative stress and prostate cancer risk in patients with stage I or II adenocarcinoma of the prostate treated with 3 different dose levels of soy isoflavones before radical prostatectomy.

- Compare prostatic tissue biomarkers of proliferation and apoptosis in patients treated with these regimens.

- Determine the potential response, in terms of tumor and prostatic intraepithelial neoplasia grade and volume, extraprostatic extension, and serum prostate-specific antigen level, in patients treated with soy isoflavones and in those treated with placebo.

- Determine the safety of soy isoflavone supplementation in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel-group study. Patients are stratified according to tumor stage (T1c vs T2). Patients are randomized to 1 of 4 treatment arms.

- Arm I (control group): Patients receive oral placebo once daily.

- Arm II: Patients receive oral soy isoflavones and oral placebo once daily.

- Arm III: Patients receive a higher dose of oral soy isoflavones and oral placebo once daily.

- Arm IV: Patients receive a higher dose (higher than arm III) of oral soy isoflavones once daily.

In all arms, treatment continues for 2-6 weeks (depending on the time from study entry to planned surgery) in the absence of unacceptable toxicity. All patients then undergo radical prostatectomy.

Patients are followed at 1 week.

PROJECTED ACCRUAL: A total of 100 patients (25 per treatment arm) will be accrued for this study within 12.5 months.

Study Design

Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Prevention

Conditions

Prostate Cancer

Intervention

soy isoflavones, conventional surgery, neoadjuvant therapy

Location

Barbara Ann Karmanos Cancer Institute
Detroit
Michigan
United States
48201-1379

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:32-0400

Clinical Trials [5623 Associated Clinical Trials listed on BioPortfolio]

Isoflavones Compared With Lycopene Before Surgery in Treating Patients With Stage I or Stage II Prostate Cancer

RATIONALE: Eating a diet rich in isoflavones, compounds found in soy foods, or lycopene, a substance found in tomatoes, may keep prostate cancer from growing. Giving isoflavones or lycopen...

Phase II Clinical Trial of Purified Isoflavones in Prostate Cancer: Comparing Safety, Effectiveness

The purpose of our study is to recruit and treat 260 men diagnosed with prostate cancer and scheduled for a prostatectomy with a capsule form of either purified isoflavones or placebo for ...

Isoflavones and Radiation Therapy in Treating Patients With Localized Prostate Cancer

RATIONALE: Eating a diet high in soy foods may slow the progression of some types of cancer. Isoflavones are compounds found in soy food that may slow the growth of prostate cancer cells a...

Isoflavones in Preventing Further Development of Cancer in Patients With Stage I or Stage II Prostate Cancer

RATIONALE: Soy isoflavones may reduce the risk of some types of cancer. It is not yet known if isoflavones are effective in preventing the development of prostate cancer. PURPOSE: This ra...

The Specific Role of Isoflavones in Reducing Prostate Cancer Risk

The purpose of this research study is to determine if giving men with early stage (Grade 1-2) prostate cancer dietary supplement from soybeans called isoflavones, will change their blood h...

PubMed Articles [32576 Associated PubMed Articles listed on BioPortfolio]

Neoadjuvant therapy in rectal cancer: how are we choosing?

Neoadjuvant therapy has revolutionized the management of rectal cancer; however, there is a need to examine the factors driving neoadjuvant treatment allocation. This study aimed to describe patterns ...

Adherence to hormonal deprivation therapy in prostate cancer in clinical practice: a retrospective, single-centre study.

Androgen-deprivation therapy is one of the options available for treating both advanced and metastatic prostate cancer (PCa). It is used as an adjuvant or neoadjuvant therapy, either alone or in combi...

Neoadjuvant Therapy for Locally Advanced Esophageal Cancer Should be Targeted to Tumor Histology.

Controversy exists over the optimal neoadjuvant therapy in patients with locally advanced esophageal cancer (EC). While most groups favor neoadjuvant chemoradiation (nCRT), some prefer preoperative ch...

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...

An Integrative Approach to Prostate Cancer.

The mostly indolent natural history and long overall survival associated with a diagnosis of prostate cancer provides a unique opportunity for men to explore diet and lifestyle interventions to alter ...

Medical and Biotech [MESH] Definitions

Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.

Therapeutic practices which are not currently considered an integral part of conventional allopathic medical practice. They may lack biomedical explanations but as they become better researched some (PHYSICAL THERAPY MODALITIES; DIET; ACUPUNCTURE) become widely accepted whereas others (humors, radium therapy) quietly fade away, yet are important historical footnotes. Therapies are termed as Complementary when used in addition to conventional treatments and as Alternative when used instead of conventional treatment.

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.

Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

Combined chemotherapy and radiotherapy given to augment some other form of treatment such as surgery. It is commonly used in the therapy of cancer.

More From BioPortfolio on "Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers)  - Mouth cancer can develop on the lip, the tongue, the floor...

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...


Searches Linking to this Trial