A Registry for Patients Treated on the Clinical Trial TAX 3503

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01813370

Enrollment

Registered

2013-03-19

Start date

2013-03-31

Completion date

2022-03-04

Last updated

2022-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

TAX 3503, MSKCC IRB#07-101, 12-225

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.

Interventions

OTHERNo intervention

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Canada, Lithuania, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026