A Registry for Patients Treated on the Clinical Trial TAX 3503

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)

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Cancer Care Manitoba
• Lithuania
  • Klaipeda, Lithuania, 92288
    • Klaipeda university hospital
  • Klinikos
    • Kauno, Klinikos, Lithuania
      • Hospital of Lithuanian University Health Sciences Kauno Klinikos
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • John Hopkins Medical Center
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Duke University Medical Center
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17601
      • Urological Associates of Lancaster
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29579
      • Carolina Urologic Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
annotating clinical outcomes	To utilize this registry for the purposes of annotating clinical outcomes to the biospecimens collected under TAX3503.	1 year
overall survival differences	Between the two arms	1 year

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): March 4, 2022
• Study Completion (ACTUAL): March 4, 2022

Study Registration Dates

• First Submitted: March 13, 2013
• First Submitted That Met QC Criteria: March 18, 2013
• First Posted (ESTIMATE): March 19, 2013

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: TAX 3503; MSKCC IRB#07-101; 12-225
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 12-225