Prostate CancerNCT01274572
Blood for Immune Response to Provenge® in HRPC
An observational study of Prostate Cancer, run by Mary Crowley Medical Research Center.
Trial summary
This study is being conducted to assess and monitor immune response in patients with minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be receiving Provenge® (Sipuleucel-T) therapy as part of their standard of care treatment regimen. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prostate Cancer
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jun 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects that will be included in this study will be receiving Provenge as standard of care treatment for their prostate cancer and will be willing to consent to the additional blood draws.
Who may be able to join
- Patients who plan to receive standard of care Provenge® (Sipuleucel-T) at their primary physican's office.
Who cannot join
- None
About this study
Official title: Blood Samples to Evaluate Immune Response to Provenge® (Sipuleucel-T) inHormone Refractory Metastatic Prostate Cancer Patients
This study is being conducted to assess and monitor immune response in patients with minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be receiving Provenge® (Sipuleucel-T) therapy as part of their standard of care treatment regimen.
Read the detailed description
This study is being conducted to assess and monitor immune response in patients with minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be receiving Provenge® (Sipuleucel-T) therapy as part of their standard of care treatment regimen. The trial only involves the collection of additional blood samples for the purposes of monitoring immune response. These samples will be taken at 7 time points before, during and after patients receive Provenge® (Sipuleucel-T). There will be no other study-specific procedures performed (other than the blood draws) nor any use of investigational agents in this study.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune Response
Standard of Care Drug Immune Response
Measured: Additional Blood Sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2011 (estimated)
- Study completionJun 2011
Why it stopped: Drug became available with insurance reimbursement
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary Crowley Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Nemunaitis, MD, Principal investigator, Mary Crowley Cancer Research Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274572
- Sponsor's protocol ID
- MC 10-11
- Status last verified
- Apr 2015
- First submitted
- 10 Jan 2011
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Samples to Evaluate Immune Response to Provenge® (Sipuleucel-T) inHormone Refractory Metastatic Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT01274572
- Acronym / sponsor ID
- MC 10-11
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Drug became available with insurance reimbursement
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mary Crowley Medical Research CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Jan 2011 (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.
This study is being conducted to assess and monitor immune response in patients with minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be receiving Provenge® (Sipuleucel-T) therapy as part of their standard of care treatment regimen.
Detailed description
This study is being conducted to assess and monitor immune response in patients with minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be receiving Provenge® (Sipuleucel-T) therapy as part of their standard of care treatment regimen. The trial only involves the collection of additional blood samples for the purposes of monitoring immune response. These samples will be taken at 7 time points before, during and after patients receive Provenge® (Sipuleucel-T). There will be no other study-specific procedures performed (other than the blood draws) nor any use of investigational agents in this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects that will be included in this study will be receiving Provenge as standard of care treatment for their prostate cancer and will be willing to consent to the additional blood draws.
Key inclusion criteria (1 listed)
- Patients who plan to receive standard of care Provenge® (Sipuleucel-T) at their primary physican's office.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immune Response
Time frame: Additional Blood Sample
Standard of Care Drug Immune Response
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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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.
John Nemunaitis, MD principal investigator
Mary Crowley Cancer Research Centers
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Mary Crowley Medical Research Center.
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 1 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: withdrawn, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Immune Response (time frame: Additional Blood Sample). 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 7 Apr 2015.