A Registry for Patients Treated on the Clinical Trial TAX 3503

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT01813370

Collaborator

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

Enrollment

Locations

108.1

Duration (Months)

6.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Other: No intervention

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

52 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official 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)

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Mar 4, 2022

Actual Study Completion Date :

Mar 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: 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.

Arm

Intervention/Treatment

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.

Other: 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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	John Hopkins Medical Center	Baltimore	Maryland	United States	21287
2	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
3	Duke University Medical Center	Durham	North Carolina	United States	27701
4	Urological Associates of Lancaster	Lancaster	Pennsylvania	United States	17601
5	Carolina Urologic Research Center	Myrtle Beach	South Carolina	United States	29579
6	Cancer Care Manitoba	Winnipeg	Manitoba	Canada
7	Hospital of Lithuanian University Health Sciences Kauno Klinikos	Kauno	Klinikos	Lithuania
8	Klaipeda University Hospital	Klaipeda		Lithuania	92288