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Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer

Primary Purpose

Hormone-Refractory Prostate Cancer

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

sipuleucel-T

APC-Placebo

About this trial

This is an interventional treatment trial for Hormone-Refractory Prostate Cancer focused on measuring asymptomatic metastatic hormone-refractory prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Visceral organ metastases
Metastatic disease expected to be in need of radiation therapy within 4 months.
Concurrent therapy with experimental agents

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

sipuleucel-T (APC8015)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival

Subjects were followed for 3 years from the time of randomization or until death.

Full Information

NCT ID

NCT01133704

First Posted

May 27, 2010

Last Updated

September 2, 2010

Sponsor

Dendreon

1. Study Identification

Unique Protocol Identification Number

NCT01133704

Brief Title

Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

May 2000 (undefined)

Primary Completion Date

March 2003 (Actual)

Study Completion Date

May 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Dendreon

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hormone-Refractory Prostate Cancer

Keywords

asymptomatic metastatic hormone-refractory prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

98 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sipuleucel-T (APC8015)

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

sipuleucel-T

Intervention Type

Biological

Intervention Name(s)

APC-Placebo

Primary Outcome Measure Information:

Title

Overall Time to Disease Progression

Description

Time Frame

from randomization to 36 months

Secondary Outcome Measure Information:

Title

Overall Survival

Description

Subjects were followed for 3 years from the time of randomization or until death.

Time Frame

Time from randomization until 36 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: Visceral organ metastases Metastatic disease expected to be in need of radiation therapy within 4 months. Concurrent therapy with experimental agents

12. IPD Sharing Statement

Citations:

PubMed Identifier

35812443

Citation

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.

Results Reference

derived

PubMed Identifier

24957547

Citation

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.

Results Reference

derived

Learn more about this trial

Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer

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