A Registry for Patients Treated on the Clinical Trial TAX 3503

Completed

• Conditions: Prostate Cancer
• Interventions: Other: No intervention

• Registration Number: NCT01813370
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-18
• Study First Posted: 2013-03-19
• Status Verified: 2022-03
• Primary Completion: 2022-03-04
• Study Completion: 2022-03-04
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pts with prostate cancer	No intervention	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.

Primary Outcome Measures

Name	Time	Method
progression free survival	1 year	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.

Secondary Outcome Measures

Name	Time	Method
annotating clinical outcomes	1 year	To utilize this registry for the purposes of annotating clinical outcomes to the biospecimens collected under TAX3503.
overall survival differences	1 year	Between the two arms

Trial Locations

Locations (8)

Klaipeda University Hospital; 🇱🇹 Klaipeda, Lithuania

John Hopkins Medical Center; 🇺🇸 Baltimore, Maryland, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Hospital of Lithuanian University Health Sciences Kauno Klinikos; 🇱🇹 Kauno, Klinikos, Lithuania

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States

Cancer Care Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Urological Associates of Lancaster; 🇺🇸 Lancaster, Pennsylvania, United States