A Registry for Patients Treated on the Clinical Trial TAX 3503

Memorial Sloan Kettering Cancer Center52 enrolled

Overview

The purpose of this study is to continue follow-up on patients who were treated on the study called TAX 3505 (MSK IRB #07-101). The sponsor of this study, has decided to end the study early, before all patients have completed all planned follow-up tests. As a result, the investigators do not yet know whether hormonal therapy alone, or in combination with docetaxel, is better at preventing prostate cancer recurrence in patients who had a rising PSA after prostatectomy. This study will continue following patients according to a schedule that is similar to that found in the TAX 3503 (MSK IRB #07-101) study in order to answer that question. This study is known as a registry study. The patients' will not receive any treatment as part of this study. Instead, they will be asked to have a blood test performed once every 12 weeks.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Prostate Cancer

Interventions

No interventionOTHER

No intervention is planned as part of this protocol. Historical data will be transferred to MSK via electronic data transfer. Patient's PSA, testosterone, and vital status data will be transferred to MSK via electronic data transfer.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The registry will include the database of all patients registered to TAX3503. Those patients who will be prospectively tracked through the registry are those who meet the following criteria: 1. The patient must have been registered to TAX3503 2. The patient must not have met the definition of progression as defined in TAX3503 while on TAX3503 Patients who have progressed or hit their 36 month post treatment date between the closure of TAX3503 and the activation of this TAX3503 Registry protocol will be permitted on the study to capture their date of progression or their 36 month post treatment progression free date. Exclusion Criteria: * Patients who were not registered to TAX3503 are not eligible to have their data stored in this registry.

Locations (8)

John Hopkins Medical Center

Baltimore, Maryland, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Urological Associates of Lancaster

Lancaster, Pennsylvania, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

Hospital of Lithuanian University Health Sciences Kauno Klinikos

Kaunas, Klinikos, Lithuania

Klaipeda University Hospital

Klaipėda, Lithuania

Outcomes

Primary Outcomes

progression free survival

For patients treated on TAX3503 that will enable the study to achieve its primary endpoint of comparing the efficacy of its treatment arms as determined by progression-free survival during the period from randomization to progression or death or last followup.

Time frame: 1 year

Secondary Outcomes

annotating clinical outcomes

To utilize this registry for the purposes of annotating clinical outcomes to the biospecimens collected under TAX3503.

Time frame: 1 year

overall survival differences

Between the two arms

Time frame: 1 year