Prostate CancerPhase 2NCT00901342
Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer
A Phase 2 study testing sipuleucel-T in people with Prostate Cancer, run by Dendreon at 18 sites in United States.
Trial summary
This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC). 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 18 sitesUnited States
- Study dates
- Oct 2009to Jun 2015
- Phase
- Phase 2
- 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
Who may be able to join
- Histologically documented adenocarcinoma of the prostate
- Metastatic disease
- Castrate resistant prostate cancer
- Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration
- Life expectancy of ≥ 3 months
- Men ≥ 18 years of age
- Adequate hematologic, renal and liver function
Who cannot join
- Presence of known lung, liver, or brain metastases
- Evidence of neuroendocrine or small cell features
- Eastern Cooperative Oncology Group (ECOG) performance status > 2
- Prior treatment with 3 infusions of sipuleucel-T (infusions of APC8015F are not exclusionary)
- Imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression
- Known malignancies other than prostate cancer that are likely to require treatment within six months of registration
Show all 17Show fewer
- A requirement for systemic immunosuppressive therapy for any reason
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or granulocyte-macrophage colony-stimulating factor
- Any infection requiring parenteral antibiotic therapy or causing fever (temp > 100.5F or > 38.1C) within 1 week prior to registration
- Any medical intervention or other condition which, in the opinion of the Principal Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives
- Treatment with any of the following medications or interventions within 28 days of registration:
- Systemic corticosteroids. Use of inhaled, intranasal, intra-articular, and topical steroids is acceptable, as is a short course (ie, ≤ 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans
- Non-steroidal anti-androgens (eg, bicalutamide, flutamide, or nilutamide)
- External beam radiation therapy or major surgery requiring general anesthetic
- Any other systemic therapy for prostate cancer including secondary hormonal therapies, such as megestrol acetate (Megace®), diethylstilbestrol (DES), and ketoconazole. Medical castration therapy is not exclusionary
- Chemotherapy
- Treatment with any other investigational product
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
The University of Chicago Medical Center
Chicago, Illinois, 60637
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242
Texas Oncology, PA - Sammons Cancer Center
Dallas, Texas, 75246
GU Oncology Research Program
Durham, North Carolina, 27710
Hematology Oncology Consultants
Greenbelt, Maryland, 20770
Myron I. Murdock MD LLC
Greenbelt, Maryland, 20770
John Theurer Cancer Center at Hackensack
Hackensack, New Jersey, 07601
Indiana University Department of Urology
Indianapolis, Indiana, 46202
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
NYU Cancer Institute
New York, New York, 10016
Mount Sinai School of Medicine Department of Urology
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Oncology Specialists, S.C.
Park Ridge, Illinois, 60068
Maine Center for Cancer Medicine
Scarborough, Maine, 04074
Virginia Mason Medical Center Urology and Renal Transplantation
Seattle, Washington, 98101
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23642
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Aurora Advanced Healthcare, Inc
Wauwatosa, Wisconsin, 53226
About this study
Official title: An Open Label Study of Sipuleucel-T in Men With Metastatic Castrate Resistant Prostate Cancer
This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC).
Read the detailed description
Subjects received sipuleucel-T at 2-week intervals, for a total of 3 infusions. The study evaluated the safety and magnitude of the immune responses to treatment with sipuleucel-T. All subjects were followed for 30 days following the last infusion of sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse event (SAE)s and cerebrovascular event (CVE)s were collected via Long Term Follow-up Telephone Assessment occurring Q6 months.
- Conditions
- Prostate Cancer
- Being tested
- sipuleucel-T
- Keywords
- Androgen independent prostate cancer (AIPC), CRPC, prostate cancer, prostate, immune therapy, immunotherapy, vaccine, dendritic cells, antigen-presenting cells, antigen presenting cells, cancer vaccine, prostate specific antigen (PSA), prostatic adenocarcinoma
- 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
Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)
| Study group | Role | What they receive |
|---|---|---|
| Sipuleucel-T | Experimental | Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions. Receives: Biological: sipuleucel-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC)
Measured: Day 0 (first infusion) and up to 3 infusions at 2-week intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2014
- Study completionJun 2015
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dendreon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Israel, MD, Study director, Valeant Pharmaceuticals North America LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901342
- Sponsor's protocol ID
- P09-1
- Status last verified
- Apr 2017
- First submitted
- 7 May 2009
- Last updated
- 23 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of Sipuleucel-T in Men With Metastatic Castrate Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT00901342
- Acronym / sponsor ID
- P09-1
- Conditions
- Prostate Cancer
- Keywords
- Androgen independent prostate cancer (AIPC), CRPC, prostate cancer, prostate, immune therapy, immunotherapy, vaccine, dendritic cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- DendreonIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Posted 12 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC).
Detailed description
Subjects received sipuleucel-T at 2-week intervals, for a total of 3 infusions. The study evaluated the safety and magnitude of the immune responses to treatment with sipuleucel-T. All subjects were followed for 30 days following the last infusion of sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse event (SAE)s and cerebrovascular event (CVE)s were collected via Long Term Follow-up Telephone Assessment occurring Q6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sipuleucel-T | Experimental | Biological: sipuleucel-TSubjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically documented adenocarcinoma of the prostate
- Metastatic disease
- Castrate resistant prostate cancer
- Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration
- Life expectancy of ≥ 3 months
Key exclusion criteria (17 listed)
- Presence of known lung, liver, or brain metastases
- Evidence of neuroendocrine or small cell features
- Eastern Cooperative Oncology Group (ECOG) performance status > 2
- Prior treatment with 3 infusions of sipuleucel-T (infusions of APC8015F are not exclusionary)
- Imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression
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® • APC8015Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF) | Biological | Sipuleucel-T |
Primary outcome
Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC)
Time frame: Day 0 (first infusion) and up to 3 infusions at 2-week intervals
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Prostate Cancer Research InstituteLink provided by the sponsor.
- US TOO InternationalLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Robert Israel, MD study director
Valeant Pharmaceuticals North America LLC
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sipuleucel-T in people with Prostate Cancer, run by Dendreon at 18 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 7 inclusion and 17 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 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2017). 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?
Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC) (time frame: Day 0 (first infusion) and up to 3 infusions at 2-week intervals). 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 23 May 2017.