A Registry for Patients Treated on the Clinical Trial TAX 3503

NCT ID: NCT01813370

Last Updated: 2022-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2022-03-04

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pts with prostate cancer

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.

No intervention

Intervention Type OTHER

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.

Interventions

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No 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Laval University

OTHER

Sponsor Role collaborator

Vancouver General Hospital

OTHER

Sponsor Role collaborator

London Health Sciences Centre

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Montreal - Hospital Notre-Dame

UNKNOWN

Sponsor Role collaborator

Princess Margaret Hospital, Canada

OTHER

Sponsor Role collaborator

CancerCare Manitoba

OTHER

Sponsor Role collaborator

Tom Baker Cancer Centre

OTHER

Sponsor Role collaborator

Urocentrum Praha s.r.o.

UNKNOWN

Sponsor Role collaborator

Fakultní nemocnice Na Bulovce

UNKNOWN

Sponsor Role collaborator

Hospital Jablonec nad Nisou, p.o

UNKNOWN

Sponsor Role collaborator

Klaipėda University

OTHER

Sponsor Role collaborator

Lithuanian University of Health Sciences

OTHER

Sponsor Role collaborator

Oncology Institute of Vilnius University

UNKNOWN

Sponsor Role collaborator

Fakultna Nemocnica s poliklinikou J.A. Reimana Presov, Klinika urologie

UNKNOWN

Sponsor Role collaborator

Martinska Fakultna Nemocnica, Urologicke klinika

UNKNOWN

Sponsor Role collaborator

Fakultna nemocnica s poliklinikou

UNKNOWN

Sponsor Role collaborator

BratislavaNemocnica ak. L Derera, Urologicka klinika

UNKNOWN

Sponsor Role collaborator

Urologic Consultants of Southeastern PA

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

GU Research Network, LLC

OTHER

Sponsor Role collaborator

Carolina Urologic Research Center

OTHER

Sponsor Role collaborator

Lancaster Urology

UNKNOWN

Sponsor Role collaborator

Kansas City Veteran Affairs Medical Center

FED

Sponsor Role collaborator

Urology San Antonio Research PA

UNKNOWN

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role collaborator

St. Alexius Medical Center Clinical Research Services

UNKNOWN

Sponsor Role collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

Vanguard Urologic Research Foundation

OTHER

Sponsor Role collaborator

The Urological Institute of Northeastern NY

UNKNOWN

Sponsor Role collaborator

Urology Associates Medical Group

UNKNOWN

Sponsor Role collaborator

Hospital de Sabadell

OTHER

Sponsor Role collaborator

Lahey Clinic

OTHER

Sponsor Role collaborator

San Bernardino Urological Associates

UNKNOWN

Sponsor Role collaborator

Columbus Urology

UNKNOWN

Sponsor Role collaborator

Niepubliczny Specjalistyczny Onkologiczny Zaklad Opienki Zdrowotnej

UNKNOWN

Sponsor Role collaborator

Vinzenzkrankenhaus Hannover, Urologische Abteilung (Uro-Onkologie)

UNKNOWN

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Morris, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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John Hopkins Medical Center

Baltimore, Maryland, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Urological Associates of Lancaster

Lancaster, Pennsylvania, United States

Site Status

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Site Status

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

Site Status

Hospital of Lithuanian University Health Sciences Kauno Klinikos

Kaunas, Klinikos, Lithuania

Site Status

Klaipeda University Hospital

Klaipėda, , Lithuania

Site Status

Countries

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United States Canada Lithuania

Related Links

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http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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12-225

Identifier Type: -

Identifier Source: org_study_id

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