Clinical trial NCT01813370: A Registry for Patients Treated on the Clinical Trial TAX 3503
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: TAX 3503
MSKCC IRB#07-101
12-225
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Laval University
name: Vancouver General Hospital
name: London Health Sciences Centre
name: Centre Hospitalier Universitaire de Montreal - Hospital Notre-Dame
name: Princess Margaret Hospital, Canada
name: CancerCare Manitoba
name: Tom Baker Cancer Centre
name: Urocentrum Praha s.r.o.
name: Fakultní nemocnice Na Bulovce
name: Hospital Jablonec nad Nisou, p.o
name: Klaipėda University
name: Lithuanian University of Health Sciences
name: Oncology Institute of Vilnius University
name: Fakultna Nemocnica s poliklinikou J.A. Reimana Presov, Klinika urologie
name: Martinska Fakultna Nemocnica, Urologicke klinika
name: Fakultna nemocnica s poliklinikou
name: BratislavaNemocnica ak. L Derera, Urologicka klinika
name: Urologic Consultants of Southeastern PA
name: Columbia University
name: GU Research Network, LLC
name: Carolina Urologic Research Center
name: Lancaster Urology
name: Kansas City Veteran Affairs Medical Center
name: Urology San Antonio Research PA
name: University of Texas Southwestern Medical Center
name: University of Cincinnati
name: St. Alexius Medical Center Clinical Research Services
name: Barbara Ann Karmanos Cancer Institute
name: Johns Hopkins University
name: Duke University
name: Vanguard Urologic Research Foundation
name: The Urological Institute of Northeastern NY
name: Urology Associates Medical Group
name: Hospital de Sabadell
name: Lahey Clinic
name: San Bernardino Urological Associates
name: Columbus Urology
name: Niepubliczny Specjalistyczny Onkologiczny Zaklad Opienki Zdrowotnej
name: Vinzenzkrankenhaus Hannover, Urologische Abteilung (Uro-Onkologie)
First posted: 2013-03-19
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are presently on TAX3503 and undergoing followup for evidence of progressive disease will be approached by their study physicians at their local sites to enter the registry. No other patient will be approached or recruited. Some sites that were part of the TAX3503 study are unable to open this registry at their site. In order to minimize the number of participants whose information might be lost, Memorial Sloan-Kettering Cancer Center (MSKCC) will inform these sites that they may refer their participants to MSKCC for this registry.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: progression free survival
timeFrame: 1 year
Secondary outcomes:
measure: annotating clinical outcomes
timeFrame: 1 year
measure: overall survival differences
timeFrame: 1 year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: John Hopkins Medical Center
state: Maryland
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Lancaster
country: United States
facility: Urological Associates of Lancaster
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: Kauno
country: Lithuania
facility: Hospital of Lithuanian University Health Sciences Kauno Klinikos
state: Klinikos
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Michael Morris, MD
role: PRINCIPAL_INVESTIGATOR
References: