Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T

An observational study of Prostate Cancer, run by Dendreon at 39 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®). Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: Sipuleucel-T
How many people: 139 participants
Where: 39 sitesUnited States
Study dates: Oct 2012to Jul 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Men at least 18 years of age with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT), and have not yet undergone leukapheresis for their first dose of sipuleucel-T.

Who may be able to join

Subjects must be at least 18 years of age
Subjects with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT)
Subjects have not yet undergone leukapheresis for their first dose of sipuleucel-T
Subjects must understand and sign an informed consent form prior to their first leukapheresis

Who cannot join

•None

Trial locations and contacts

39 sites in 1 country.

City, postcode or hospital

39 sites in 1 country

United States39 sites

Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, 19004
Tufts Medical Center
Boston, Massachusetts, 02111
St. Louis Cancer Care, LLP
Bridgeton, Missouri, 63044
TriState Urologic Services PSC Inc., dba The Urology Group
Cincinnati, Ohio, 45212
South Carolina Oncology Associates
Columbia, South Carolina, 29210
The Urology Center of Colorado
Denver, Colorado, 80211
Henry Ford Health System
Detroit, Michigan, 48202
National Translational Research Group, Inc.
East Setauket, New York, 11733
Texas Oncology - Fort Worth
Fort Worth, Texas, 76104, 76132
Carolina Urology Partners
Gastonia, North Carolina, 28054
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052, 89014, 89074
First Urology, PSC
Jeffersonville, Indiana, 47130
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, 89128, 98148
Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center
Lincoln, Nebraska, 68510
Tower Urology / Tower Research Institute
Los Angeles, California, 90048
Prostate Oncology Specialists, Inc.
Marina del Rey, California, 90292
Delaware Valley Urology, LLC
Mount Laurel, New Jersey, 08054
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Urology Associates, P.C.
Nashville, Tennessee, 37209
Tulane University
New Orleans, Louisiana, 70112
Providence Health & Services
Portland, Oregon, 97213
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601
Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina
Raleigh, North Carolina, 27607
21st Century Oncology
Scottsdale, Arizona, 85251
Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023
University of Washington Medical Centerl
Seattle, Washington, 98195
Highland Clinic
Shreveport, Louisiana, 71106
Oregon Urology Institute
Springfield, Oregon, 97477
St. Louis Cancer Care, LLP
St Louis, Missouri, 63127
Associated Medical Professionals of NY, PLLC
Syracuse, New York, 13210
Montefiore Medical Center
The Bronx, New York, 10461
Chesapeake Urology Research Associates
Towson, Maryland, 21204
Michigan Institute of Urology
Troy, Michigan, 48084
Northwest Cancer Specialists, PC
Tualatin, Oregon, 97062
Urologic Specialists of Oklahoma
Tulsa, Oklahoma, 74146
Northwest Cancer Specialists
Vancouver, Washington, 98684, 98683
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462
Howard University Cancer Center
Washington D.C., District of Columbia, 20060
Cancer Center of Kansas
Wichita, Kansas, 67214

Other trials in United States

About this study

The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).

Read the detailed description

Subjects will receive sipuleucel-T, and potentially other medications, as part of the clinical trial in which they are concurrently enrolled. For this study, cellular and humoral immune responses will be assessed. No additional study treatments will be conducted beyond what is required for the subject's concurrent clinical trial.

Conditions: Prostate Cancer
Being tested: Sipuleucel-T
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sipuleucel-TBiological
Also called PROVENGE, APC8015
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.

Study groups in NCT01727154
Study group	Role	What they receive
Sipuleucel-T		Not described Receives: Biological: Sipuleucel-T

What is being measured

The primary outcome is the main question the study is designed to answer.

The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T).
The primary immune response analysis population will include all subjects who receive all 3 infusions of sipuleucel-T. The primary analysis will measure the percentage of subjects who exhibit any immune response at any post-treatment time point (6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T).
Measured: Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Jul 2017

First posted15 Nov 2012 (estimated)
Study startOct 2012
Primary completionJul 2017
Study completionJul 2017

Why it stopped: Administrative reasons

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 139 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01727154
Sponsor's protocol ID: P11-4
Acronym: PRIME
Status last verified: Jul 2019
First submitted: 12 Nov 2012
Last updated: 19 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T
ClinicalTrials.gov ID: NCT01727154
Acronym / sponsor ID: PRIME / P11-4
Conditions: Prostate Cancer
Study type: Observational
Recruitment status: TerminatedReason stopped: Administrative reasons
Enrolment: 139 participants (actual)
Lead sponsor: DendreonIndustry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Jul 2017 (actual)
Study completion: Jul 2017 (actual)
First posted: 15 Nov 2012 (estimated)
Results: Posted 19 Aug 2019

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 evaluate the immune response induced by sipuleucel-T (Provenge®).

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Sipuleucel-T	–	Biological: Sipuleucel-T

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Men at least 18 years of age with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT), and have not yet undergone leukapheresis for their first dose of sipuleucel-T.

Key inclusion criteria (4 listed)

Subjects must be at least 18 years of age
Subjects with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT)
Subjects have not yet undergone leukapheresis for their first dose of sipuleucel-T
Subjects must understand and sign an informed consent form prior to their first leukapheresis

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.

Interventions

Intervention	Type	Arms
Sipuleucel-TAlso: PROVENGE, APC8015Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.	Biological	Sipuleucel-T

Primary outcome

The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T).
Time frame: Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T.
The primary immune response analysis population will include all subjects who receive all 3 infusions of sipuleucel-T. The primary analysis will measure the percentage of subjects who exhibit any immune response at any post-treatment time point (6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T).

Results and safety

Results posted to the registry on 19 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sipuleucel-T	139	80

Primary outcome: The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T).

Time frame: Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T.. Count of participants. Unit: Participants

Measure	Sipuleucel-T n = 118
Subjects who had an immune response	110
Subjects who did not have an immune response	8

Population analysed: This study was terminated early due to administrative reasons. A min of 200 patients were needed to obtain reliable data but only 139 were enrolled, 123 treated only 118 had analyzable immune response samples. Therefore this was a descriptive analysis of only 118pts with an immune response after dosing with Provenge. No comparative group available.

Adverse events

Time frame: All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not monitored/assessed. Reporting requirements for serious adverse events (SAEs) are described in the respective protocols (P10-3 and P12-1) for the trial in which each subject is concurrently enrolled.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sipuleucel-T	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Early termination leading to small numbers of subjects analyzed as a minimum of 200 patients were needed to obtain reliable data; however only 123 were treated. Given the small number of patients enrolled, analyses do not provide reliable results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
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Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
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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.

Bruce Brown, MD study director

Dendreon Pharmaceuticals, LLC

39 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 Dendreon at 39 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 4 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: stopped early, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 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?

Yes. Results are posted in the registry (first posted 19 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T). (time frame: Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01727154.

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 19 Aug 2019.