Prostatic NeoplasmPhase 2NCT01431391
Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
A Phase 2 study testing sipuleucel-T and leuprolide acetate in people with Prostatic Neoplasm and Prostate Cancer, run by Dendreon at 14 sites in United States.
Trial summary
The main purpose of this study was to determine whether ADT started before or after sipuleucel-T led to a better immune system response. This study also evaluated the safety of sipuleucel-T and ADT treatment, immune system responses over time, the characteristics of sipuleucel-T, and changes in prostate specific… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasm, Prostate Cancer, Prostatic Adenocarcinoma
- What is being tested?
- sipuleucel-T and leuprolide acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 14 sitesUnited States
- Study dates
- Sep 2011to Dec 2014
- 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
- Hormone-sensitive prostate cancer
- Non-metastatic disease, as evidenced by negative bone scan or computed tomography of the abdomen and pelvis
- ECOG performance status ≤ 1
- Histologically documented prostate cancer
- Prior primary therapy for prostate cancer
- Rising PSA with a PSADT of ≤ 12 months
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- Testosterone ≥ 200 ng/dL ≤ 28 days of registration
- Adequate hematologic, renal, and liver function
- Must live in a permanent residence within a comfortable driving distance (round-trip within one day) to the clinical research site
Who cannot join
- Requires systemic ongoing immunosuppressive therapy
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF
- Prior sipuleucel-T therapy
- Prior ADT therapy ≤ 6 months prior to registration or ≥ 6 months duration in total
- If subject has a history of any other stage III/IV malignancy, the subject must be disease free and off any malignancy-related treatment for at least 10 years. If the subject has a history of any stage I-II malignancy, the subject must be disease free and off any malignancy-related treatment for at least 5 years.
- Prior experimental immunotherapy or on an experimental clinical trial within 1 year
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- Received denosumab or XRT ≤ 6 months prior to registration
- Received chemotherapy or GM-CSF ≤ 90 days prior to registration
- Received any of the following medications or interventions ≤ 28 days prior to registration
- major surgery requiring general anesthesia
- systemic immunosuppressive therapy
- other prescription treatment for prostate cancer
- Active infection within 1 week of registration
- Likely to receive XRT or surgery for prostate cancer during the study period
- Any medical intervention, any other condition, or any circumstances that could compromise the study.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
NYOH Albany Cancer Center at Patroon Creek
Albany, New York, 12206
Community Care Physicians, PC
Albany, New York, 12208
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
The Urology Center of Colorado
Denver, Colorado, 80211
Urology Center of Alabama
Homewood, Alabama, 35209
University of California San Diego / Moores Cancer Center
La Jolla, California, 91914
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Keck Hospital of USC
Los Angeles, California, 90033
LAC + USC Medical Center
Los Angeles, California, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Grand Strand Urology
Myrtle Beach, South Carolina, 29572
Urology San Antonio Research
San Antonio, Texas, 78229
Virginia Mason Medical Center
Seattle, Washington, 98101
Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
Official title: A Randomized, Open-Label, Phase 2 Trial Examining the Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men With Non-metastatic Prostate Cancer and a Rising Serum Prostate Specific Antigen After Primary Therapy
The main purpose of this study was to determine whether ADT started before or after sipuleucel-T led to a better immune system response. This study also evaluated the safety of sipuleucel-T and ADT treatment, immune system responses over time, the characteristics of sipuleucel-T, and changes in prostate specific antigen (PSA) values over time.
Read the detailed description
Multicenter, randomized, open-label study, with subjects allocated (1:1) to 1 of 2 study arms, using a stratified randomization based on:
- Prostate-specific antigen doubling time (PSADT): ≤ 3 months or > 3 months and ≤ 12 months. • Primary therapy: radical prostatectomy (RP) or radiation, including brachytherapy, (XRT) or RP + XRT.
Arm 1: Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
Arm 2: Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
Cellular and humoral immune responses were assessed for Arm 2 subjects at 12, 8, and 4 weeks pre infusion 1, and in all subjects (both arms) at pre-leukapheresis 1, 2, and 3, and post-infusion 1, 2 and 3, and at the following time points after the third infusion: Weeks 2, 6, and 12 and Months 6, 9, 12, 15, 18, 21, and 24.
Safety assessments included adverse event (AE) monitoring, laboratory tests (complete blood count (CBC) and serum chemistry), vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, physical examination, as well PSA and testosterone monitoring. The study was complete at the 27-Month visit for Arm 1 and the 24-Month visit for Arm 2.
- Being tested
- sipuleucel-T, leuprolide acetate
- Keywords
- Immune therapy, Cancer vaccine, Therapeutic vaccine, Therapeutic cancer vaccine, Vaccine, Dendritic cells, PSA, Androgen deprivation therapy, Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms, Prostatic Diseases, Androgens, Hormones, Adenocarcinoma, Carcinoma, Neoplasms, Glandular and Epithelial, Immunology, Hormone therapy
- Medical subject headings
- Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms, Prostatic Diseases, Adenocarcinoma, Carcinoma, Neoplasms, Glandular and Epithelial
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).
leuprolide acetateDrug
Also called Eligard®
45.0 mg depot injection, 2 doses 6 months apart
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Sipuleucel-T followed by ADT | Experimental | Arm 1: Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Receives: Biological: sipuleucel-T; Drug: leuprolide acetate |
| Arm 2: ADT followed by sipuleucel-T | Experimental | Arm 2: Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions. Receives: Biological: sipuleucel-T; Drug: leuprolide acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024
Immune response at month 24 as evaluated by IFN-γ ELISPOT specific for PA2024 following sipuleucel-T/ADT treatment regimens to determine if order of administration impacted immune response.
Measured: PA2024 ELISPOT counts at Month 24
Secondary outcomes (1)
Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024
A participant was considered to have an immune response it the post-baseline PA2024-specific IFN-g ELISPOT count was >18
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2014
- Study completionDec 2014
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 Prostatic NeoplasmStudies 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
- 68 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
- NCT01431391
- Sponsor's protocol ID
- P10-2
- Status last verified
- Apr 2017
- First submitted
- 5 Aug 2011
- Last updated
- 30 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 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Phase 2 Trial Examining the Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men With Non-metastatic Prostate Cancer and a Rising Serum Prostate Specific Antigen After Primary Therapy
- ClinicalTrials.gov ID
- NCT01431391
- Acronym / sponsor ID
- P10-2
- Keywords
- Immune therapy, Cancer vaccine, Therapeutic vaccine, Therapeutic cancer vaccine, Vaccine, Dendritic cells, PSA, Androgen deprivation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- DendreonIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Sep 2011 (estimated)
- Results
- Posted 30 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study was to determine whether ADT started before or after sipuleucel-T led to a better immune system response. This study also evaluated the safety of sipuleucel-T and ADT treatment, immune system responses over time, the characteristics of sipuleucel-T, and changes in prostate specific antigen (PSA) values over time.
Detailed description
Multicenter, randomized, open-label study, with subjects allocated (1:1) to 1 of 2 study arms, using a stratified randomization based on:
- Prostate-specific antigen doubling time (PSADT): ≤ 3 months or > 3 months and ≤ 12 months. • Primary therapy: radical prostatectomy (RP) or radiation, including brachytherapy, (XRT) or RP + XRT.
Arm 1: Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
Arm 2: Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
Cellular and humoral immune responses were assessed for Arm 2 subjects at 12, 8, and 4 weeks pre infusion 1, and in all subjects (both arms) at pre-leukapheresis 1, 2, and 3, and post-infusion 1, 2 and 3, and at the following time points after the third infusion: Weeks 2, 6, and 12 and Months 6, 9, 12, 15, 18, 21, and 24.
Safety assessments included adverse event (AE) monitoring, laboratory tests (complete blood count (CBC) and serum chemistry), vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, physical examination, as well PSA and testosterone monitoring. The study was complete at the 27-Month visit for Arm 1 and the 24-Month visit for Arm 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Sipuleucel-T followed by ADT | Experimental | Biological: sipuleucel-T, Drug: leuprolide acetateArm 1: Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. |
| Arm 2: ADT followed by sipuleucel-T | Experimental | Biological: sipuleucel-T, Drug: leuprolide acetateArm 2: Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Hormone-sensitive prostate cancer
- Non-metastatic disease, as evidenced by negative bone scan or computed tomography of the abdomen and pelvis
- ECOG performance status ≤ 1
- Histologically documented prostate cancer
- Prior primary therapy for prostate cancer
Key exclusion criteria (15 listed)
- Requires systemic ongoing immunosuppressive therapy
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF
- Prior sipuleucel-T therapy
- Prior ADT therapy ≤ 6 months prior to registration or ≥ 6 months duration in total
- If subject has a history of any other stage III/IV malignancy, the subject must be disease free and off any malignancy-related treatment for at least 10 years. If the subject has a history of any stage I-II malignancy, the subject must be disease free and off any malignancy-related treatment for at least 5 years.
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 | Arm 1: Sipuleucel-T followed by ADT, Arm 2: ADT followed by sipuleucel-T |
| leuprolide acetateAlso: Eligard®45.0 mg depot injection, 2 doses 6 months apart | Drug | Arm 1: Sipuleucel-T followed by ADT, Arm 2: ADT followed by sipuleucel-T |
Primary outcome
Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024
Time frame: PA2024 ELISPOT counts at Month 24
Immune response at month 24 as evaluated by IFN-γ ELISPOT specific for PA2024 following sipuleucel-T/ADT treatment regimens to determine if order of administration impacted immune response.
1 secondary outcome
Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024
Time frame: Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
14 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 and leuprolide acetate in people with Prostatic Neoplasm and Prostate Cancer, run by Dendreon at 14 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 9 inclusion and 15 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 30 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 14 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 30 May 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?
Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024 (time frame: PA2024 ELISPOT counts at Month 24). 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 30 May 2017.