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Long-Term Follow-Up Study of Patients Who Were Diagnosed With Prostate Cancer While Undergoing Treatment on a Prostate Cancer Prevention Trial

2014-08-27 03:46:16 | BioPortfolio

Summary

RATIONALE: Learning about the long-term effects of chemoprevention drugs, such as finasteride, in patients with prostate cancer may help doctors plan better treatment and follow-up care.

PURPOSE: This clinical trial is following patients who were diagnosed with prostate cancer while undergoing treatment with either finasteride or a placebo on the Prostate Cancer Prevention Trial (PCPT).

Description

OBJECTIVES:

- Compare the time to metastases in patients who were diagnosed with high grade or low grade prostate cancer on or before December 31, 2003 and were treated with finasteride or placebo while enrolled on the Prostate Cancer Prevention Trial (SWOG-9217).

- Compare the difference in time to secondary therapy after definitive therapy with radiotherapy or radical prostatectomy in these patients.

- Compare the difference in time to prostate-specific antigen recurrence after definitive therapy with radiotherapy or radical prostatectomy in these patients.

- Compare the difference in all-cause and prostate cancer mortality in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to survival status (alive vs deceased).

Patients provide information about their general health, prostate cancer treatment history, prostate cancer status (i.e., disease progression and metastases data), and prostate-specific antigen (PSA) test results at baseline and then every 6 months for up to 8 years. Next of kin of deceased patients are asked to release the patients' medical records in order to obtain information about the patients' prostate cancer treatment history, prostate cancer progression and metastases, PSA test results, and cause of death.

PROJECTED ACCRUAL: Approximately 2,397 patients will be accrued for this study.

Study Design

N/A

Conditions

Prostate Cancer

Intervention

clinical observation, quality-of-life assessment

Location

Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale
Florida
United States
33308

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:46:16-0400

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Medical and Biotech [MESH] Definitions

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.

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