A Registry for Patients Treated on the Clinical Trial TAX 3503

Prostate Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813370
• Other study ID #: 12-225
• Status: Completed
• Start date: March 2013
• Est. completion date: March 4, 2022

Study information

• Verified date: March 2022
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 4, 2022
• Est. primary completion date: March 4, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Cancer Care Manitoba	Winnipeg	Manitoba
Lithuania	Hospital of Lithuanian University Health Sciences Kauno Klinikos	Kauno	Klinikos
Lithuania	Klaipeda University Hospital	Klaipeda
United States	John Hopkins Medical Center	Baltimore	Maryland
United States	Duke University Medical Center	Durham	North Carolina
United States	Urological Associates of Lancaster	Lancaster	Pennsylvania
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (40)

Lead Sponsor

Collaborator

Memorial Sloan Kettering Cancer Center

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, Fakultna Nemocnica s poliklinikou J.A. Reimana Presov, Klinika urologie, Fakultní nemocnice Na Bulovce, GU Research Network, LLC, Hospital de Sabadell, Hospital Jablonec nad Nisou, p.o, Johns Hopkins University, Kansas City Veteran Affairs Medical Center, Klaipeda 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)

Countries where clinical trial is conducted

United States,  Canada,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival	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.	1 year
Secondary	annotating clinical outcomes	To utilize this registry for the purposes of annotating clinical outcomes to the biospecimens collected under TAX3503.	1 year
Secondary	overall survival differences	Between the two arms	1 year

External Links

•   Memorial Sloan Kettering Cancer Center