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

NCT01133704 | Completed Phase 3 Results

• 1 other identifier: D9902A
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hormone-Refractory Prostate Cancer

Keywords

asymptomatic metastatic hormone-refractory prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  from randomization to 36 months

Secondary Outcomes (1)

• Overall Survival

  Time from randomization until 36 months

Study Arms (2)

sipuleucel-T (APC8015)

ACTIVE COMPARATOR

Biological: sipuleucel-T

Placebo

PLACEBO COMPARATOR

Biological: APC-Placebo

Interventions

sipuleucel-T BIOLOGICAL

sipuleucel-T (APC8015)

APC-Placebo BIOLOGICAL

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dendreon: lead

Related Publications (2)

• 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.

  PMID: 35812443 DERIVED

• 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.

  PMID: 24957547 DERIVED

MeSH Terms

Interventions

sipuleucel-T

Results Point of Contact

• Title: Kathleen Picha
• Organization: Dendreon Corporation

kpicha@dendreon.com

206-265-4545

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 31, 2010
• Study Start: May 1, 2000
• Primary Completion: March 1, 2003
• Study Completion: May 1, 2005
• Last Updated: September 8, 2010
• Results First Posted: September 2, 2010

Record last verified: 2010-09