Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer

Prostate Cancer Clinical Trial

— mCRPC  

Official title:

An Open-Label Multicenter Study of Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer Patients Previously Treated With Sipuleucel-T on Dendreon Study P-11 (NCT00779402)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01338012
• Other study ID #: P10-1
• Status: Terminated
• Phase: Phase 2
• First received: March 2, 2011
• Last updated: June 1, 2017
• Start date: December 2011
• Est. completion date: April 2015

Study information

• Verified date: June 2017
• Source: Dendreon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases.

Description:

Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases.

During the Active Phase eligible subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. Subjects returned to the clinic for Week 6, Week 10, Month 6, and Month 12 visits. After the Month 12 visit, subjects were to enter the Long Term Follow-up Phase, in which they were contacted every 6 months via telephone.

Study Objectives:

Primary: Evaluate the immune response generated by sipuleucel-T.

Secondary: Evaluate the safety of sipuleucel-T and explore the correlation between sipuleucel-T immune response and overall survival.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Previously randomized in Dendreon's P-11 study (NCT00779402) and received at least one infusion of sipuleucel-T

• Radiologic evidence of metastasis

• Castrate resistant prostate cancer. Subjects must have current or historical evidence of disease progression concomitant with surgical or medical castration, as demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease

• Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration

• Adequate hematologic function

Exclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status > 2

• Treatment with chemotherapy within 3 months prior to registration

• Treatment with systemic corticosteroids, abiraterone acetate, external beam radiation therapy, or any investigational product for prostate cancer within 28 days prior to registration

• Treatment with commercial sipuleucel-T (Provenge®)

• Current or imminent pathologic long-bone fracture or spinal cord compression

• Known malignancies other than prostate cancer likely to require treatment within 6 months following registration

• A requirement for systemic immunosuppressive therapy for any reason

• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF

• Any infection requiring antibiotic therapy or causing fever within 1 week prior to registration

• Any surgery requiring general anesthetic within 28 days prior to registration

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• sipuleucel-T
Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).

Locations

Country	Name	City	State
United States	Orange County Urology Associates	Laguna Hills	California
United States	Oregon Health & Science University	Portland	Oregon
United States	Virginia Mason Hospital	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Dendreon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Study Participants Enrolled and Treated Prior to Study Termination	Number of study participants that were enrolled and treated in this trial following completion of study P-11 and prior to study termination.	Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015