To Evaluate Sipuleucel-T Manufactured With Different Concentrations of Prostate Adenocarcinoma (PA2024) Antigen

Prostate Cancer Clinical Trial

— ProACT  

Official title:

A Randomized, Multicenter, Single Blind Study in Men With Metastatic Androgen Independent Prostate Cancer to Evaluate Sipuleucel-T Manufactured With Different Concentrations of PA2024 Antigen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715078
• Other study ID #: P07-2
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2008
• Last updated: October 5, 2015
• Start date: August 2008
• Est. completion date: April 2015

Study information

• Verified date: October 2015
• Source: Dendreon
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with different concentrations of PA2024 antigen

Description:

This is a multicenter, single blind, Phase 2 study. Subjects will receive the investigational product, sipuleucel-T, manufactured with 1 of 3 different concentrations of PA2024 antigen. The purpose of this study is to compare the changes in CD54 upregulation between each of these 3 groups of subjects. The study will also evaluate the levels of immune response, the length of survival, the role of circulating tumor cell levels in the blood, and changes in quality of life in each of the 3 groups of subjects. All subjects will be blinded to their cohort assignment to ensure unbiased completion of the quality of life (QOL) questionnaires. All subjects will be followed for this study for the remainder of their lives.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: April 2015
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

For a subject to be eligible for participation in this study, all of the following criteria must be satisfied.

• Histologically documented adenocarcinoma of the prostate.

• Metastatic disease.

• Progressive androgen independent prostate cancer.

• Serum PSA >= 5.0 ng/mL.

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

• Men >= 18 years of age.

• Adequate hematologic, renal and liver function.

• In order to ensure the integrity of the study data is maintained, study participants must be able to complete all study visits. For this reason, study participation is limited to those who live in a permanent residence within a comfortable driving distance (roundtrip within one day) to the clinical research site.

Exclusion Criteria:

A subject will not be eligible for participation in this study if any of the following criteria apply.

• The presence of known lung, liver, or brain metastases, malignant pleural effusions, or malignant ascites.

• A requirement for treatment with opioid analgesics for any reason within 21 days prior to registration.

• Moderate to severe disease related pain.

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

• Use of non-steroidal antiandrogens within 6 weeks of registration.

• Anti-androgen withdrawal response.

• Treatment with chemotherapy within 3 months of registration.

• More than 2 chemotherapy regimens prior to registration.

• Initiation or discontinuation of bisphosphonate therapy within 28 days prior to registration.

• Treatment with any of the following medications or interventions within 28 days of registration:

• Systemic corticosteroids,

• External beam radiation therapy or surgery,

• Dietary and herbal supplements, as well as alternative treatments that have evidence of hormonal and/or anticancer properties (e.g., PC-SPES or PC-SPEC) and saw palmetto,

• Megestrol acetate (Megace(R)), diethylstilbesterol (DES), or cyproterone acetate, ++Ketoconazole,

• 5-alpha-reductase inhibitors,

• High dose calcitriol [1,25(OH)2Vitamin D] (i.e., > 0.5 mg/day).

• Any other systemic therapy for prostate cancer (except for medical castration).

• Treatment with any investigational vaccine within 2 years of registration or treatment with any other investigational product within 28 days of registration.

• Participation in any previous study involving sipuleucel-T, regardless of whether the subject received sipuleucel-T (APC8015) or placebo.

• Known pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression.

• A history of stage III or greater cancer, excluding prostate cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for >= 3 years at the time of 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 granulocyte-macrophage colony-stimulating factor (GM-CSF).

• Any infection requiring parenteral antibiotic therapy or causing fever (temp > 100.5°F or > 38.1°C) within 1 week prior to registration.

• Any medical intervention or other condition which, in the opinion of the Principal Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• Sipuleucel-T
Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with prostate antigen PA2024.

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana
United States	UCSD Moores Cancer Center	La Jolla	California
United States	Columbia University Medical Center	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	Urology of Virginia, Sentara Medical Group	Norfolk	Virginia
United States	Kaiser Permanente	Portland	Oregon
United States	Northwest Cancer Specialists	Portland	Oregon
United States	Providence Medical Center	Portland	Oregon
United States	Sharp Clinical Oncology Research	San Diego	California
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Virginia Mason Medical Center Urology and Renal Transplantation	Seattle	Washington
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Dendreon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the Cumulative CD54 Upregulation Ratio Between Each of the Cohorts.	An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.	Baseline and up to week 36	No
Secondary	Evaluate the Magnitude of the Immune Response in Each of the Cohorts.		Overall survival will be evaluated after the last living subject has completed the Month 36 visit.	Yes
Secondary	Evaluate the Overall Survival in Each of the Cohorts.		Overall survival will be evaluated after the last living subject has completed the Month 36 visit.	Yes

External Links

•   American Foundation of Urological Diseases
•   Prostate Cancer Research Institute
•   Us TOO International