Hormone-Refractory Prostate CancerPhase 3NCT01133704
Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
A Phase 3 study testing sipuleucel-T in people with Hormone-Refractory Prostate Cancer, run by Dendreon.
Trial summary
This is a randomized, double blind, placebo controlled trial of immunotherapy with autologous antigen-loaded dendritic cells (Provenge, APC8015) for asymptomatic, metastatic, hormone-refractory prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hormone-Refractory Prostate Cancer
- What is being tested?
- sipuleucel-T
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- May 2000to May 2005
- Phase
- Phase 3
- 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 as evidenced by soft tissue and/or bony metastases
- Prostate-specific antigen value of at least 5 ng/mL
- Tumor progression while on hormonal therapy
- Castration levels of testosterone (defined as less than 50 ng/dL)
- Life expectancy of at least 16 weeks
- Adequate hematologic, renal, and liver function
Who cannot join
- Visceral organ metastases
- Metastatic disease expected to be in need of radiation therapy within 4 months.
- Concurrent therapy with experimental agents
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge®, APC8015) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
This is a randomized, double blind, placebo controlled trial of immunotherapy with autologous antigen-loaded dendritic cells (Provenge, APC8015) for asymptomatic, metastatic, hormone-refractory prostate cancer.
- Conditions
- Hormone-Refractory Prostate Cancer
- Being tested
- sipuleucel-T, APC-Placebo
- Keywords
- asymptomatic metastatic hormone-refractory prostate cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sipuleucel-TBiological
APC-PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| sipuleucel-T (APC8015) | Active comparator | Not described Receives: Biological: sipuleucel-T |
| Placebo | Placebo comparator | Not described Receives: Biological: APC-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Time to Disease Progression
Overall time to disease progression in subjects with asymptomatic metastatic hormone-refractory prostate cancer treated with sipuleucel-T (APC8015) compared to overall time to disease progression in subjects treated with placebo.
Measured: from randomization to 36 months
Secondary outcomes (1)
Overall Survival
Subjects were followed for 3 years from the time of randomization or until death.
Measured: Time from randomization until 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startMay 2000
- Primary completionMar 2003
- Study completionMay 2005
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 (2)Papers the sponsor has linked to this study.
- Other trials for Hormone-Refractory 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dendreon
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133704
- Sponsor's protocol ID
- D9902A
- Status last verified
- Sep 2010
- First submitted
- 27 May 2010
- Last updated
- 8 Sep 2010
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Ju M, Fan J, Zou Y, Yu M, Jiang L, Wei Q, Bi J, Hu B, Guan Q, Song X, Dong M, Wang L, Yu L, Wang Y, Kang H, Xin W, Zhao L. Computational Recognition of a Regulatory T-cell-specific Signature With Potential Implications in Prognosis, Immunotherapy, and Therapeutic Resistance of Prostate Cancer. Front Immunol. 2022 Jun 23;13:807840. doi: 10.3389/fimmu.2022.807840. eCollection 2022.
PubMed 35812443Small EJ, Higano CS, Kantoff PW, Whitmore JB, Frohlich MW, Petrylak DP. Time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T. Prostate Cancer Prostatic Dis. 2014 Sep;17(3):259-64. doi: 10.1038/pcan.2014.21. Epub 2014 Jun 24.
PubMed 24957547
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge®, APC8015) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT01133704
- Acronym / sponsor ID
- D9902A
- Conditions
- Hormone-Refractory Prostate Cancer
- Keywords
- asymptomatic metastatic hormone-refractory prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- DendreonIndustry (pharma, biotech, devices)
- Study start
- May 2000
- Primary completion
- Mar 2003 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 31 May 2010 (estimated)
- Results
- Posted 2 Sep 2010
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 randomized, double blind, placebo controlled trial of immunotherapy with autologous antigen-loaded dendritic cells (Provenge, APC8015) for asymptomatic, metastatic, hormone-refractory prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sipuleucel-T (APC8015) | Active comparator | Biological: sipuleucel-T |
| Placebo | Placebo comparator | Biological: APC-Placebo |
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 as evidenced by soft tissue and/or bony metastases
- Prostate-specific antigen value of at least 5 ng/mL
- Tumor progression while on hormonal therapy
- Castration levels of testosterone (defined as less than 50 ng/dL)
Key exclusion criteria (3 listed)
- Visceral organ metastases
- Metastatic disease expected to be in need of radiation therapy within 4 months.
- Concurrent therapy with experimental agents
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 | Biological | sipuleucel-T (APC8015) |
| APC-Placebo | Biological | Placebo |
Primary outcome
Overall Time to Disease Progression
Time frame: from randomization to 36 months
Overall time to disease progression in subjects with asymptomatic metastatic hormone-refractory prostate cancer treated with sipuleucel-T (APC8015) compared to overall time to disease progression in subjects treated with placebo.
1 secondary outcome
Overall Survival
Time frame: Time from randomization until 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35812443Ju M, Fan J, Zou Y, Yu M, Jiang L, Wei Q, Bi J, Hu B, Guan Q, Song X, Dong M, Wang L, Yu L, Wang Y, Kang H, Xin W, Zhao L. Computational Recognition of a Regulatory T-cell-specific Signature With Potential Implications in Prognosis, Immunotherapy, and Therapeutic Resistance of Prostate Cancer. Front Immunol. 2022 Jun 23;13:807840. doi: 10.3389/fimmu.2022.807840. eCollection 2022.
- Derived from this study: PubMed 24957547Small EJ, Higano CS, Kantoff PW, Whitmore JB, Frohlich MW, Petrylak DP. Time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T. Prostate Cancer Prostatic Dis. 2014 Sep;17(3):259-64. doi: 10.1038/pcan.2014.21. Epub 2014 Jun 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sipuleucel-T in people with Hormone-Refractory Prostate Cancer, run by Dendreon.
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 3 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 8 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 2 Sep 2010). 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?
Overall Time to Disease Progression (time frame: from randomization to 36 months). 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 NCT01133704, which also lists 2 linked publications.
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 8 Sep 2010.