Prostate CancerPROVENGENCT02237170
Immune Monitoring on Sipuleucel-T
An observational study of Prostate Cancer, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
Trial summary
The purpose of this protocol is perform comprehensive immune monitoring studies in patients with castration-resistant prostate cancer receiving Sipuleucel-T in an effort to better understand the mechanism of action of this treatment. 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
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2012to Dec 2016
- 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 will be recruited from those patients who receive their care at Mount Sinai Medical Center, or a participating site
Who may be able to join
- Age > 18 years of age
- Written informed consent obtained
- Patients with castration-resistant prostate cancer who are initiating Sipuleucel-T as standard therapy
- No prior systemic chemotherapy for metastatic prostate cancer
- Hemoglobin > 9 mg/dl
Who cannot join
- Patients unable to understand the research protocol and/or provide informed consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, 89169
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: A Systems Biology Approach to Immune Monitoring in Patients With Castration-resistant Prostate Cancer Receiving SiPuleucel-T
The purpose of this protocol is perform comprehensive immune monitoring studies in patients with castration-resistant prostate cancer receiving Sipuleucel-T in an effort to better understand the mechanism of action of this treatment.
Read the detailed description
The primary objectives of this study are to:
- Establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with Sipuleucel-T.
- Determine the induction and the quality of prostate antigen-specific T cell immunity in patients undergoing treatment with Sipuleucel-T.
- Correlate whole-blood RNA transcript-based signatures with clinical outcomes in patients treated with Sipuleucel-T.
- Evaluate the cytokine and chemokine milieu in the peripheral blood pre- and post-treatment with Sipuleucel-T.
- Conditions
- Prostate Cancer
- Keywords
- Sipuleucel-T, Castration Resistant Prostate Cancer, Provenge
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Castration Resistant Metastatic Prostate Cancer | Castration Resistant Metastatic Prostate Cancer with no history of prior systemic chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Regulatory T cells (Tregs)
Establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with Sipuleucel-T looking at the change in regulatory T cells at 1 year post treatment compared to at baseline
Measured: baseline and 1 year
Secondary outcomes (6)
Change in Antigen Presenting Cells
Establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with Sipuleucel-T looking at the change in antigen presenting cells: DCs and B cells at 1 year post treatment compared to at baseline
Measured: baseline and 1 year
Change in Prostate Antigen-specific T Cell Immunity
Measured: baseline and one year
Whole-blood RNA transcript-based signatures
whole-blood RNA transcript-based signatures correlate with overall survival
Measured: baseline
Whole-blood RNA transcript-based signatures
whole-blood RNA transcript-based signatures correlate with overall survival
Measured: up to 1 year
Change in cytokine milieu
Measured: baseline and 1 year
Change in chemokine milieu
Measured: baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startJun 2012
- Primary completionDec 2016
- Study completionDec 2016
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 Icahn School of Medicine at Mount SinaiThe 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Galsky, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237170
- Sponsor's protocol ID
- GCO 11-1689
- Acronym
- PROVENGE
- Status last verified
- Jan 2017
- First submitted
- 9 Sep 2014
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systems Biology Approach to Immune Monitoring in Patients With Castration-resistant Prostate Cancer Receiving SiPuleucel-T
- ClinicalTrials.gov ID
- NCT02237170
- Acronym / sponsor ID
- PROVENGE / GCO 11-1689
- Conditions
- Prostate Cancer
- Keywords
- Sipuleucel-T, Castration Resistant Prostate Cancer, Provenge
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Sep 2014 (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 protocol is perform comprehensive immune monitoring studies in patients with castration-resistant prostate cancer receiving Sipuleucel-T in an effort to better understand the mechanism of action of this treatment.
Detailed description
The primary objectives of this study are to:
- Establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with Sipuleucel-T.
- Determine the induction and the quality of prostate antigen-specific T cell immunity in patients undergoing treatment with Sipuleucel-T.
- Correlate whole-blood RNA transcript-based signatures with clinical outcomes in patients treated with Sipuleucel-T.
- Evaluate the cytokine and chemokine milieu in the peripheral blood pre- and post-treatment with Sipuleucel-T.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Castration Resistant Metastatic Prostate Cancer | – | –Castration Resistant Metastatic Prostate Cancer with no history of prior systemic chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from those patients who receive their care at Mount Sinai Medical Center, or a participating site
Key inclusion criteria (5 listed)
- Age > 18 years of age
- Written informed consent obtained
- Patients with castration-resistant prostate cancer who are initiating Sipuleucel-T as standard therapy
- No prior systemic chemotherapy for metastatic prostate cancer
- Hemoglobin > 9 mg/dl
Key exclusion criteria (1 listed)
- Patients unable to understand the research protocol and/or provide informed consent
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
Change in Regulatory T cells (Tregs)
Time frame: baseline and 1 year
Establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with Sipuleucel-T looking at the change in regulatory T cells at 1 year post treatment compared to at baseline
6 secondary outcomes
Change in Antigen Presenting Cells
Time frame: baseline and 1 year
Change in Prostate Antigen-specific T Cell Immunity
Time frame: baseline and one year
Whole-blood RNA transcript-based signatures
Time frame: baseline
Whole-blood RNA transcript-based signatures
Time frame: up to 1 year
Change in cytokine milieu
Time frame: baseline and 1 year
Change in chemokine milieu
Time frame: baseline and 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 4 Jan 2017.
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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.
Matthew Galsky, MD principal investigator
Icahn School of Medicine at Mount Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
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 5 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 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Change in Regulatory T cells (Tregs) (time frame: baseline and 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 4 Jan 2017.