A Registry for Patients Treated on the Clinical Trial TAX 3503

Status:	Active, not recruiting
Conditions:	Prostate Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	10/10/2018
Start Date:	March 2013
End Date:	March 2019

A Registry for Patients Treated on the Clinical Trial TAX 3503 (A Randomized, Open Label, Multicenter, Phase III, 2-Arm Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Subjects With a Rising PSA Following Definitive Local Therapy)

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.

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.

We found this trial at

sites

Carolina Urologic Research Center

823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572

(843) 449-1010 ext.268