NCT01813370

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2022

Completed
Last Updated

March 8, 2022

Status Verified

March 1, 2022

Enrollment Period

9 years

First QC Date

March 13, 2013

Last Update Submit

March 7, 2022

Conditions

Prostate Cancer

Keywords

TAX 3503MSKCC IRB#07-10112-225

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • annotating clinical outcomes

    1 year

  • overall survival differences

    1 year

Study Arms (1)

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

Interventions

No interventionOTHER

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.

Pts with prostate cancer

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who were not registered to TAX3503 are not eligible to have their data stored in this registry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

John Hopkins Medical Center

Baltimore, Maryland, 21287, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Duke University Medical Center

Durham, North Carolina, 27701, United States

Location

Urological Associates of Lancaster

Lancaster, Pennsylvania, 17601, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29579, United States

Location

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

Location

Hospital of Lithuanian University Health Sciences Kauno Klinikos

Kaunas, Klinikos, Lithuania

Location

Klaipeda University Hospital

Klaipėda, 92288, Lithuania

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Serum PSA evaluations Serum testosterone levels

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Michael Morris, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 19, 2013

Study Start

March 1, 2013

Primary Completion

March 4, 2022

Study Completion

March 4, 2022

Last Updated

March 8, 2022

Record last verified: 2022-03

Locations

US(5)CA(1)LI(2)