Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

A Phase 3 study testing sipuleucel-T in people with Prostate Cancer, run by Dendreon at 34 sites in United States.

Completed

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

Trial summary

Rationale: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known if vaccine therapy is effective for prostate cancer. Purpose: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not… 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
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 127 participants
Where: 34 sitesUnited States
Study dates: Nov 1999to Sep 2004
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

Metastatic disease as evidenced by soft tissue and/or bony metastases.
Baseline PSA value of at least 5 ng/mL. All subjects must have stable or rising PSA.
Tumor progression after hormonal therapy.
Hormonal therapy consisting of castration by orchiectomy or LHRH agonists for treatment of prostate cancer. Castration levels of testosterone (< 50 ng/dL) must be documented for all subjects including subjects who underwent orchiectomy as therapy for cancer of the prostate.
A subject is eligible if he initially responded to antiandrogen withdrawal (> 25% decrease in PSA) but at the time of registration demonstrated tumor progression. A subject is eligible if he failed to respond to antiandrogen withdrawal.
Subjects have no cancer-related pain and do not regularly require analgesics for cancer-related pain.

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ECOG Performance Status of 0 or 1.
Life expectancy of at least 16 weeks.
Adequate hematologic, renal, and liver function.

Who cannot join

Visceral organ metastases (e.g., liver, lung, brain) or cytologically positive effusions (e.g., pleural effusions or ascites).
Metastatic disease expected to be in need of radiation therapy within 4 months.
Concurrent therapy with experimental agents.
Systemic corticosteroids at doses greater than 40 mg hydrocortisone per day for any reason other than treatment of prostate cancer within the previous 6 months without prior approval.
Please note that there are additional eligibility criteria. The study center will determine if you meet all of the criteria.

Trial locations and contacts

34 sites in 1 country.

City, postcode or hospital

34 sites in 1 country

United States34 sites

Abington Hematology Oncology Associates, Incorporated
Abington, Pennsylvania, 19001
Albany Regional Cancer Center
Albany, New York, 12208
Bryn Mawr Urology
Bryn Mawr, Pennsylvania, 19010
Office of Guy Bernstein, M.D.
Bryn Mawr, Pennsylvania, 19010
AKSM Clinical Research Corporation
Columbus, Ohio, 43214
American Oncology Resources
Dallas, Texas, 75246
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
Center for Medical Oncology
Garden City, New York, 11530
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Saint Mary Regional Cancer Center
Langhorne, Pennsylvania, 19047
North Penn Hospital
Lansdale, Pennsylvania, 19446-1200
St. Barnabas Medical Center
Livingston, New Jersey, 07039
Loma Linda University Medical Center
Loma Linda, California, 92354
Morristown Memorial Hospital
Morristown, New Jersey, 07962-1956
St. Vincents Comprehensive Cancer Center
New York, New York, 10011
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
St. Luke's-Roosevelt Hospital
New York, New York, 10019
New York Presbyterian Hospital - Cornell Campus
New York, New York, 10021
Devine Tidewater Urology
Norfolk, Virginia, 23507
Office of Barry S. Berman
Orlando, Florida, 32806
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, 97213-2967
Cancer and Blood Institute of the Desert
Rancho Mirage, California, 92270
Eisenhower Medical Center
Rancho Mirage, California, 92270
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
University of Rochester Cancer Center
Rochester, New York, 14642
Sidney Kimmel Cancer Center
San Diego, California, 92121
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
Hematology/Oncology Associates of NE Pennsylvania, P.C.
Scranton, Pennsylvania, 18510
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Cancer Care Northwest
Spokane, Washington, 99202
Hematology Oncology Northwest, P.C.
Tacoma, Washington, 98405
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, 10461
New York Medical College
Valhalla, New York, 10595
Office of Glenn Tisman
Whittier, California, 90601

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About this study

Official title: A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge) for Asymptomatic Metastatic Hormome-Refractory Prostate Cancer

Rationale: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known if vaccine therapy is effective for prostate cancer.

Purpose: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Read the detailed description

Objectives:

Compare the time to progression, time to development of disease-related pain, and incidence of grade 3 or worse treatment-related adverse events in patients with asymptomatic metastatic hormone refractory adenocarcinoma of the prostate treated with APC8015 versus control infusion. II. Compare response rate and duration of response in these patients.

Outline: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Autologous dendritic cell precursors (ADCP) are harvested on weeks 0, 2, and 4. Patients receive APC8015 comprised of ADCP activated with prostatic acid phosphatase-sargramostim (GM-CSF) fusion protein IV over 30 minutes beginning 2 days after each harvest for a total of 3 infusions. Arm II: ADCP are harvested as in arm I. Patients receive unactivated ADCP IV over 30 minutes beginning 2 days after each harvest for a total of 3 infusions. Pain is assessed weekly for up to 3 years or until 4 weeks after objective disease progression. Patients are followed monthly for up to 3 years or until disease progression. At the time of disease progression, patients treated on arm II may receive treatment on Protocol D9903.

Projected Accrual: A total of 120 patients (80 in arm I and 40 in arm II) will be accrued for this study.

Conditions: Prostate Cancer
Being tested: sipuleucel-T, Placebo
Keywords: adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
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 APC8015, Provenge
Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
PlaceboBiological
Approximately one-third of the autologous quiescent antigen presenting cells (APCs) prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.

Study groups in NCT00005947
Study group	Role	What they receive
sipuleucel-T	Active comparator	Not described Receives: Biological: sipuleucel-T
Placebo	Placebo comparator	Not described Receives: Biological: Placebo

What is being measured

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

Time to Objective Disease Progression
The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).
Measured: 36 months from randomization

Secondary outcomes (1)

Overall Survival
Overall Survival
Measured: From randomization to 36 months

Timeline

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

Nov 1999Sep 2004

First posted5 Mar 2004 (estimated)
Study startNov 1999
Primary completionSep 2004
Study completionSep 2004

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 (4)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 3
Primary purpose: Treatment
Allocation: Randomised
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00005947
Sponsor's protocol ID: D9901 CDR0000067868
Other IDs: DEN-D9901, NCI-G00-1789
Status last verified: Oct 2010
First submitted: 5 Jul 2000
Last updated: 1 Nov 2010
Results posted: Yes, on ClinicalTrials.gov

Publications

Higano CS, Schellhammer PF, Small EJ, Burch PA, Nemunaitis J, Yuh L, Provost N, Frohlich MW. Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. Cancer. 2009 Aug 15;115(16):3670-9. doi: 10.1002/cncr.24429.
PubMed 19536890
Small EJ, Schellhammer PF, Higano CS, Redfern CH, Nemunaitis JJ, Valone FH, Verjee SS, Jones LA, Hershberg RM. Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer. J Clin Oncol. 2006 Jul 1;24(19):3089-94. doi: 10.1200/JCO.2005.04.5252.
PubMed 16809734
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 35812443
Small 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

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 1 Nov 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) for Asymptomatic Metastatic Hormome-Refractory Prostate Cancer
ClinicalTrials.gov ID: NCT00005947
Acronym / sponsor ID: D9901 CDR0000067868
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 127 participants (actual)
Lead sponsor: DendreonIndustry (pharma, biotech, devices)
Study start: Nov 1999
Primary completion: Sep 2004 (actual)
Study completion: Sep 2004 (actual)
First posted: 5 Mar 2004 (estimated)
Results: Posted 1 Nov 2010

Clinical summary

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

Rationale: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known if vaccine therapy is effective for prostate cancer.

Purpose: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Detailed description

Objectives:

Compare the time to progression, time to development of disease-related pain, and incidence of grade 3 or worse treatment-related adverse events in patients with asymptomatic metastatic hormone refractory adenocarcinoma of the prostate treated with APC8015 versus control infusion. II. Compare response rate and duration of response in these patients.

Projected Accrual: A total of 120 patients (80 in arm I and 40 in arm II) will be accrued for this study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
sipuleucel-T	Active comparator	Biological: sipuleucel-T
Placebo	Placebo comparator	Biological: Placebo

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)

Metastatic disease as evidenced by soft tissue and/or bony metastases.
Baseline PSA value of at least 5 ng/mL. All subjects must have stable or rising PSA.
Tumor progression after hormonal therapy.
Hormonal therapy consisting of castration by orchiectomy or LHRH agonists for treatment of prostate cancer. Castration levels of testosterone (< 50 ng/dL) must be documented for all subjects including subjects who underwent orchiectomy as therapy for cancer of the prostate.
A subject is eligible if he initially responded to antiandrogen withdrawal (> 25% decrease in PSA) but at the time of registration demonstrated tumor progression. A subject is eligible if he failed to respond to antiandrogen withdrawal.

Key exclusion criteria (5 listed)

Visceral organ metastases (e.g., liver, lung, brain) or cytologically positive effusions (e.g., pleural effusions or ascites).
Metastatic disease expected to be in need of radiation therapy within 4 months.
Concurrent therapy with experimental agents.
Systemic corticosteroids at doses greater than 40 mg hydrocortisone per day for any reason other than treatment of prostate cancer within the previous 6 months without prior approval.
Please note that there are additional eligibility criteria. The study center will determine if you meet all of the criteria.

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: APC8015, ProvengeAutologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.	Biological	sipuleucel-T
PlaceboApproximately one-third of the autologous quiescent antigen presenting cells (APCs) prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.	Biological	Placebo

Primary outcome

Time to Objective Disease Progression
Time frame: 36 months from randomization
The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).

1 secondary outcome

Overall Survival
Time frame: From randomization to 36 months

Results and safety

Results posted to the registry on 1 Nov 2010, 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	82	25
Placebo	45	4

Primary outcome: Time to Objective Disease Progression

Time frame: 36 months from randomization. Median (95% Confidence Interval). Unit: Weeks

Measure	Sipuleucel-T n = 82	Placebo n = 45
Value	11.7 (9.1 to 16.6)	10.0 (8.7 to 13.1)

Sipuleucel-T vs Placebo: Hazard Ratio (HR): 1.45 (95% CI 0.99 to 2.11), p = 0.052, Log Rank
Sipuleucel-T vs Placebo: Hazard Ratio (HR): 0.69 (95% CI 0.47 to 1.01), p = 0.052, Log Rank

Population analysed: all randomized participants

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 4 years, 8 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sipuleucel-T	22 of 82 (26.8%)	82 of 82 (100%)	Not reported
Placebo	8 of 45 (17.8%)	44 of 45 (97.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19536890Higano CS, Schellhammer PF, Small EJ, Burch PA, Nemunaitis J, Yuh L, Provost N, Frohlich MW. Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. Cancer. 2009 Aug 15;115(16):3670-9. doi: 10.1002/cncr.24429.
Results publication: PubMed 16809734Small EJ, Schellhammer PF, Higano CS, Redfern CH, Nemunaitis JJ, Valone FH, Verjee SS, Jones LA, Hershberg RM. Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer. J Clin Oncol. 2006 Jul 1;24(19):3089-94. doi: 10.1200/JCO.2005.04.5252.
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.

Eric J. Small, MD study chair

University of California, San Francisco

34 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sipuleucel-T in people with Prostate Cancer, run by Dendreon at 34 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 5 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 1 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 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. 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 1 Nov 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?

Time to Objective Disease Progression (time frame: 36 months from randomization). 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 NCT00005947, which also lists 4 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 1 Nov 2010.