Prostate CancerPhase 2NeoACTNCT00715104

Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer

A Phase 2 study testing Sipuleucel-T with Booster and Sipuleucel-T without Booster in people with Prostate Cancer, run by Dendreon at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant treatment in men with localized prostate cancer. 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 with Booster and Sipuleucel-T without Booster
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 7 sitesUnited States
Study dates: Jul 2008to Dec 2013
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

Adenocarcinoma of the prostate.
Subject is scheduled for RP as the initial therapy for localized prostate cancer.
Subject is ≥ 18 years of age.
Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Subject has adequate hematologic, renal, and liver function.

Who cannot join

Subject has any evidence of metastasis.
Subject received hormones, including luteinizing hormone-releasing hormone agonists, antiandrogens, or 5 α-reductase inhibitors at any time prior to study screening.
Subject has received prior radiation therapy or chemotherapy for prostate cancer.
Subject has received systemic steroid therapy within 14 days.
Subject has a history of stage III or greater cancer, excluding prostate cancer.
Subjects with a history of basal or squamous cell skin cancers are allowed, provided that the subject was adequately treated and is disease-free at the time of study screening.
Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years prior to study screening.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Kaiser Permanente Portland
Portland, Oregon, 97227
Oregon Health & Science University
Portland, Oregon, 97239
University of Utah School of Medicine
Salt Lake City, Utah, 84132
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
Virginia Mason Medical Center
Seattle, Washington, 98101
Seattle Cancer Care Alliance
Seattle, Washington, 98102

Other trials in United States

About this study

Official title: An Open Label, Phase 2 Trial of Immunotherapy With Sipuleucel-T (Provenge®) as Neoadjuvant Treatment in Men With Localized Prostate Cancer

This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant treatment in men with localized prostate cancer.

Read the detailed description

This is a single center, open label, Phase 2 study. Subjects will be treated with 3 infusions of sipuleucel-T prior to a scheduled radical prostatectomy (RP) surgery. To assess the immune response following treatment with sipuleucel-T, tissue from the prostatectomy specimen will be compared with tissue from the core biopsy specimen obtained prior to treatment with sipuleucel T. Following RP, subjects will be randomized to receive either a booster infusion of sipuleucel T or no further treatment with sipuleucel-T (i.e., booster: no booster).

Conditions: Prostate Cancer
Being tested: Sipuleucel-T with Booster, Sipuleucel-T without Booster
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-T with BoosterBiological
Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.
Sipuleucel-T without BoosterBiological
Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.

Study groups in NCT00715104
Study group	Role	What they receive
Sipuleucel-T with Booster	Experimental	Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP. Receives: Biological: Sipuleucel-T with Booster
Sipuleucel-T without Booster	Experimental	Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment. Receives: Biological: Sipuleucel-T without Booster

What is being measured

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

Change in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject
CD3+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.
Measured: Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)

Secondary outcomes (8)

Change in the Number of Infiltrating CD4+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject
CD4+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.
Measured: Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)
Change in the Number of Infiltrating CD8+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject
CD8+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.
Measured: Pre-treatment biopsy (baseline) and post-RP (12 weeks following sipuleucel-T)
Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood
Antigen PA2024-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays.
This analysis was performed as previously described in Fong L et al. (J Immunol. 2001;167(12):7150-7156.). The unit of analysis is the number of IFN-γ ELISPOT counts per 300,000 peripheral blood mononuclear cells.
Measured: Baseline (screening visit) and up to 12-weeks post-RP visit (24 weeks following sipuleucel-T)
Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood
Antigen PAP-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays. PAP = Prostatic Acid Phosphatase.
Measured: Baseline (screening visit) and up to 12-weeks post-RP visit (24 months post sipuleucel-T)
Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood.
The number of PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells).
Measured: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP
Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood.
The number of PAP-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). PAP = Prostatic Acid Phosphatase.
Measured: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP
Comparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups
The number of Antigen PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster.
Measured: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP
Comparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups
The number of Antigen PAP-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster. PAP = Prostatic Acid Phosphatase.
Measured: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP

Timeline

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

Jul 2008Dec 2013

First posted15 Jul 2008 (estimated)
Study startJul 2008
Primary completionDec 2012
Study completionDec 2013

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.
Publications (1)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00715104
Sponsor's protocol ID: P07-1
Acronym: NeoACT
Status last verified: Apr 2015
First submitted: 11 Jul 2008
Last updated: 4 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Sheikh N, Cham J, Zhang L, DeVries T, Letarte S, Pufnock J, Hamm D, Trager J, Fong L. Clonotypic Diversification of Intratumoral T Cells Following Sipuleucel-T Treatment in Prostate Cancer Subjects. Cancer Res. 2016 Jul 1;76(13):3711-8. doi: 10.1158/0008-5472.CAN-15-3173. Epub 2016 May 23.
PubMed 27216195

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?

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Study at a glance

From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Phase 2 Trial of Immunotherapy With Sipuleucel-T (Provenge®) as Neoadjuvant Treatment in Men With Localized Prostate Cancer
ClinicalTrials.gov ID: NCT00715104
Acronym / sponsor ID: NeoACT / P07-1
Conditions: Prostate Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: DendreonIndustry (pharma, biotech, devices)
Collaborators: University of California, San Francisco
Study start: Jul 2008
Primary completion: Dec 2012 (actual)
Study completion: Dec 2013 (actual)
First posted: 15 Jul 2008 (estimated)
Results: Posted 1 Apr 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant treatment in men with localized prostate cancer.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sipuleucel-T with Booster	Experimental	Biological: Sipuleucel-T with BoosterSubjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.
Sipuleucel-T without Booster	Experimental	Biological: Sipuleucel-T without BoosterSubjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Adenocarcinoma of the prostate.
Subject is scheduled for RP as the initial therapy for localized prostate cancer.
Subject is ≥ 18 years of age.
Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Subject has adequate hematologic, renal, and liver function.

Key exclusion criteria (7 listed)

Subject has any evidence of metastasis.
Subject received hormones, including luteinizing hormone-releasing hormone agonists, antiandrogens, or 5 α-reductase inhibitors at any time prior to study screening.
Subject has received prior radiation therapy or chemotherapy for prostate cancer.
Subject has received systemic steroid therapy within 14 days.
Subject has a history of stage III or greater cancer, excluding prostate cancer.

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-T with BoosterSipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.	Biological	Sipuleucel-T with Booster
Sipuleucel-T without BoosterSipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.	Biological	Sipuleucel-T without Booster

Primary outcome

Change in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject
Time frame: Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)
CD3+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.

8 secondary outcomes

Change in the Number of Infiltrating CD4+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject
Time frame: Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)
Change in the Number of Infiltrating CD8+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject
Time frame: Pre-treatment biopsy (baseline) and post-RP (12 weeks following sipuleucel-T)
Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood
Time frame: Baseline (screening visit) and up to 12-weeks post-RP visit (24 weeks following sipuleucel-T)
Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood
Time frame: Baseline (screening visit) and up to 12-weeks post-RP visit (24 months post sipuleucel-T)
Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood.
Time frame: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP
Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood.
Time frame: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP
Comparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups
Time frame: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP
Comparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups
Time frame: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP

Results and safety

Results posted to the registry on 1 Apr 2015, 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 With Booster	18	18
Sipuleucel-T Without Booster	16	16
Sipuleucel-T Without Randomization to Booster	8	8

Primary outcome: Change in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject

Time frame: Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment). Mean (Standard Error). Unit: cells/μm2

Measure	Biopsy Benign Tissue n = 37	Post-RP Benign Tissue n = 37	Post-RP Tumor Tissue n = 37	Post-RP Tumor Interface n = 37
Value	2.33 (0.34)	2.03 (0.19)	1.98 (0.18)	6.39 (0.61)

Biopsy Benign Tissue vs Post-RP Benign Tissue: % Subjects with 2-fold increase: 16.2 (95% CI 1.7 to 30.7), p = 1.000, Chi-squared
Biopsy Benign Tissue vs Post-RP Tumor Tissue: % Subjects with 2-fold increase: 18.9 (95% CI 3.5 to 34.3), p = 1.000, Chi-squared
Biopsy Benign Tissue vs Post-RP Tumor Interface: % Subjects with 2-fold increase: 70.3 (95% CI 52.3 to 88.3), p <0.001, Chi-squared

Population analysed: All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP. Results are not presented by arm because all assessments were performed prior to randomization to booster.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sipuleucel-T With Booster	1 of 18 (5.6%)	18 of 18 (100%)	Not reported
Sipuleucel-T Without Booster	4 of 16 (25%)	14 of 16 (87.5%)	Not reported
Sipuleucel-T Without Randomization to Booster	1 of 8 (12.5%)	8 of 8 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27216195Sheikh N, Cham J, Zhang L, DeVries T, Letarte S, Pufnock J, Hamm D, Trager J, Fong L. Clonotypic Diversification of Intratumoral T Cells Following Sipuleucel-T Treatment in Prostate Cancer Subjects. Cancer Res. 2016 Jul 1;76(13):3711-8. doi: 10.1158/0008-5472.CAN-15-3173. Epub 2016 May 23.
Prostate Cancer Research InstituteLink provided by the sponsor.
National Prostate Cancer CoalitionLink provided by the sponsor.
USTOO InternationalLink 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.

Andy Sandler, MD study director

Dendreon

7 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 with Booster and Sipuleucel-T without Booster in people with Prostate Cancer, run by Dendreon at 7 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 7 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 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 1 Apr 2015). 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?

Change in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject (time frame: Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)). 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 NCT00715104, which also lists 1 linked publication.

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 May 2015.