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NCT Number: NCT01813370

A Registry for Patients Treated on the Clinical Trial TAX 3503

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Cancer Care Manitoba, Winnipeg, Manitoba, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • The patient must have been registered to TAX3503
  • 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.

Treatment and study plan

No intervention

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.

Primary outcomes

  1. progression free survival

    Time frame: 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 outcomes

  1. annotating clinical outcomes

    Time frame: 1 year

    To utilize this registry for the purposes of annotating clinical outcomes to the biospecimens collected under TAX3503.

  2. overall survival differences

    Time frame: 1 year

    Between the two arms

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Barbara Ann Karmanos Cancer Institute
  • BratislavaNemocnica ak. L Derera, Urologicka klinika
  • CancerCare Manitoba
  • Carolina Urologic Research Center
  • Centre Hospitalier Universitaire de Montreal - Hospital Notre-Dame
  • Columbia University
  • Columbus Urology
  • Duke University
  • Fakultna Nemocnica s poliklinikou J.A. Reimana Presov, Klinika urologie
  • Fakultna nemocnica s poliklinikou
  • Fakultní nemocnice Na Bulovce
  • GU Research Network, LLC
  • Hospital Jablonec nad Nisou, p.o
  • Hospital de Sabadell
  • Johns Hopkins University
  • Kansas City Veteran Affairs Medical Center
  • Klaipėda University
  • Lahey Clinic
  • Lancaster Urology
  • Laval University
  • Lithuanian University of Health Sciences
  • London Health Sciences Centre
  • Martinska Fakultna Nemocnica, Urologicke klinika
  • Niepubliczny Specjalistyczny Onkologiczny Zaklad Opienki Zdrowotnej
  • Oncology Institute of Vilnius University
  • Princess Margaret Hospital, Canada
  • San Bernardino Urological Associates
  • St. Alexius Medical Center Clinical Research Services
  • The Urological Institute of Northeastern NY
  • Tom Baker Cancer Centre
  • University of Cincinnati
  • University of Texas Southwestern Medical Center
  • Urocentrum Praha s.r.o.
  • Urologic Consultants of Southeastern PA
  • Urology Associates Medical Group
  • Urology San Antonio Research PA
  • Vancouver General Hospital
  • Vanguard Urologic Research Foundation
  • Vinzenzkrankenhaus Hannover, Urologische Abteilung (Uro-Onkologie)

Registry information

Official study title

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)

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
Mar 19, 2013
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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