Overview

This trial is active, not recruiting.

Conditions prostate cancer metastatic, hormone refractory prostate cancer
Treatments sipuleucel-t, abiraterone acetate
Phase phase 2
Sponsor Dendreon
Start date December 2011
End date April 2016
Trial size 69 participants
Trial identifier NCT01487863, P11-3

Summary

The purpose of this study is to evaluate the impact of concurrent versus sequential administration of abiraterone acetate plus prednisone on product parameters of sipuleucel-T, and to assess the safety and efficacy of sipuleucel-T with concurrent or sequential administration of abiraterone acetate plus prednisone in men with metastatic castrate resistant prostate cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Subjects will receive sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment will start the next day after the first infusion of sipuleucel-T and continue for 26 weeks or until disease progression, unacceptable toxicity, or death, whichever occurs first.
sipuleucel-t PROVENGE(R)
Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
abiraterone acetate ZYTIGA(R)
Abiraterone acetate (1000 mg po QD) is administered in combination with prednisone (5 mg po BD) for a total of 26 weeks.
(Experimental)
Subjects will receive sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone will start 6 weeks after the last infusion of sipuleucel-T and continue for 26 weeks or until disease progression, unacceptable toxicity, or death, whichever occurs first.
sipuleucel-t PROVENGE(R)
Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
abiraterone acetate ZYTIGA(R)
Abiraterone acetate (1000 mg po QD) is administered in combination with prednisone (5 mg po BD) for a total of 26 weeks.

Primary Outcomes

Measure
Evaluate cumulative sipuleucel-T CD54 upregulation
time frame: Over the course of sipuleucel-T therapy (approximately 1 month)

Secondary Outcomes

Measure
Evaluate sipuleucel-T product parameters
time frame: Over the course of sipuleucel-T therapy (approximately 1 month)
Evaluate the peripheral immune response to sipuleucel-T
time frame: From baseline through 26 weeks
Evaluate safety of sipuleucel-T therapy with concurrent or sequential administration of abiraterone acetate plus prednisone
time frame: From registration to 30 days following the last study treatment

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - historically documented prostate cancer confirmed by a pathology report from prostate biopsy or radical prostatectomy specimen - metastatic status as evidenced by imaging obtained /= 2.0 ng/mL - castrate levels of testosterone (

Additional Information

Official title A Randomized, Open-label, Phase 2 Trial of Sipuleucel-T With Concurrent Versus Sequential Administration of Abiraterone Acetate Plus Prednisone in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Dendreon.