Prostate CancerNCT01813370
A Registry for Patients Treated on the Clinical Trial TAX 3503
An observational study of Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 52 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Mar 2013to 4 Mar 2022
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who were not registered to TAX3503 are not eligible to have their data stored in this registry.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States5 sites
John Hopkins Medical Center
Baltimore, Maryland, 21287
Duke University Medical Center
Durham, North Carolina, 27701
Urological Associates of Lancaster
Lancaster, Pennsylvania, 17601
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29579
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Lithuania2 sites
Hospital of Lithuanian University Health Sciences Kauno Klinikos
Kaunas, Klinikos
Klaipeda University Hospital
Klaipėda, 92288
About this study
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)
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.
- Conditions
- Prostate Cancer
- Being tested
- No intervention
- Keywords
- TAX 3503, MSKCC IRB#07-101, 12-225
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
annotating clinical outcomes
To utilize this registry for the purposes of annotating clinical outcomes to the biospecimens collected under TAX3503.
Measured: 1 year
overall survival differences
Between the two arms
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startMar 2013
- Primary completion4 Mar 2022
- Study completion4 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Laval University, Vancouver General Hospital, London Health Sciences Centre, Centre Hospitalier Universitaire de Montreal - Hospital Notre-Dame, Princess Margaret Hospital, Canada, CancerCare Manitoba, Tom Baker Cancer Centre, Urocentrum Praha s.r.o., Fakultní nemocnice Na Bulovce, Hospital Jablonec nad Nisou, p.o, Klaipėda University, Lithuanian University of Health Sciences, 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, Columbia University, GU Research Network, LLC, Carolina Urologic Research Center, Lancaster Urology, Kansas City Veteran Affairs Medical Center, Urology San Antonio Research PA, University of Texas Southwestern Medical Center, University of Cincinnati, St. Alexius Medical Center Clinical Research Services, Barbara Ann Karmanos Cancer Institute, Johns Hopkins University, Duke University, Vanguard Urologic Research Foundation, The Urological Institute of Northeastern NY, Urology Associates Medical Group, Hospital de Sabadell, Lahey Clinic, San Bernardino Urological Associates, Columbus Urology, Niepubliczny Specjalistyczny Onkologiczny Zaklad Opienki Zdrowotnej, Vinzenzkrankenhaus Hannover, Urologische Abteilung (Uro-Onkologie)
- Responsible party
- Sponsor
- Investigators
- Michael Morris, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813370
- Sponsor's protocol ID
- 12-225
- Status last verified
- Mar 2022
- First submitted
- 13 Mar 2013
- Last updated
- 8 Mar 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01813370
- Acronym / sponsor ID
- 12-225
- Conditions
- Prostate Cancer
- Keywords
- TAX 3503, MSKCC IRB#07-101, 12-225
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Laval University, Vancouver General Hospital, London Health Sciences Centre, Centre Hospitalier Universitaire de Montreal - Hospital Notre-Dame, Princess Margaret Hospital, Canada, CancerCare Manitoba, Tom Baker Cancer Centre, Urocentrum Praha s.r.o., Fakultní nemocnice Na Bulovce, Hospital Jablonec nad Nisou, p.o, Klaipėda University, Lithuanian University of Health Sciences, 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, Columbia University, GU Research Network, LLC, Carolina Urologic Research Center, Lancaster Urology, Kansas City Veteran Affairs Medical Center, Urology San Antonio Research PA, University of Texas Southwestern Medical Center, University of Cincinnati, St. Alexius Medical Center Clinical Research Services, Barbara Ann Karmanos Cancer Institute, Johns Hopkins University, Duke University, Vanguard Urologic Research Foundation, The Urological Institute of Northeastern NY, Urology Associates Medical Group, Hospital de Sabadell, Lahey Clinic, San Bernardino Urological Associates, Columbus Urology, Niepubliczny Specjalistyczny Onkologiczny Zaklad Opienki Zdrowotnej, Vinzenzkrankenhaus Hannover, Urologische Abteilung (Uro-Onkologie)
- Study start
- Mar 2013
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 19 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pts with prostate cancer | – | Other: No interventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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:
Key exclusion criteria (1 listed)
- Patients who were not registered to TAX3503 are not eligible to have their data stored in this registry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo 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. | Other | Pts with prostate cancer |
Primary outcome
progression free survival
Time frame: 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.
2 secondary outcomes
annotating clinical outcomes
Time frame: 1 year
overall survival differences
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Morris, MD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Lithuania, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.