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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)


N/A
18 Years
N/A
Open (Enrolling by invite only)
Male
Prostate Cancer

Thank you

Trial Information

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)


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.

Type of Study:

Observational [Patient Registry]

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

progression free survival

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Michael Morris, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-225

NCT ID:

NCT01813370

Start Date:

March 2013

Completion Date:

March 2014

Related Keywords:

  • Prostate Cancer
  • TAX 3503
  • MSKCC IRB#07-101
  • 12-225
  • Prostatic Neoplasms

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021
John Hopkins Medical Center Baltimore, Maryland  21287