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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01431391
Other study ID # P10-2
Secondary ID
Status Completed
Phase Phase 2
First received August 5, 2011
Last updated February 11, 2015
Start date September 2011
Est. completion date December 2014

Study information

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

Clinical Trial Summary

The main purpose of this study is to determine whether ADT started before or after sipuleucel-T leads to a better immune system response. This study will also evaluate the safety of sipuleucel-T treatment, immune system responses over time, the characteristics of sipuleucel-T, and changes in prostate specific antigen (PSA) values over time.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically documented prostate cancer

- Prior primary therapy for prostate cancer

- Rising prostate specific antigen (PSA) with a PSA doubling time (PSADT) of = 12 months

- Non-metastatic disease with ECOG performance status = 1

- Testosterone = 200 ng/dL = 28 days of registration

- Adequate hematologic, renal, and liver function

- Must live in a permanent residence within a comfortable driving distance (roundtrip within one day) to the clinical research site

Exclusion Criteria:

- Requires systemic ongoing immunosuppressive therapy

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

- Prior sipuleucel-T therapy

- Prior ADT therapy = 6 months prior to registration or more than 6 months duration in total

- Disease-free and off treatment for 10 years for other stage III/IV malignancies or 5 years for other stage I/II malignancies

- Prior experimental immunotherapy within 1 year

- Received denosumab or XRT = 6 months prior to registration

- Received chemotherapy or GM-CSF = 90 days prior to registration

- Received any of the following medications or interventions = 28 days prior to registration

- major surgery requiring general anesthesia

- systemic immunosuppressive therapy

- other prescription treatment for prostate cancer

- Active infection within 1 week of registration

- Likely to receive XRT or surgery for prostate cancer during the study period

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Biological:
sipuleucel-T
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).
Drug:
leuprolide acetate
45.0 mg depot injection, 2 doses 6 months apart

Locations

Country Name City State
United States Community Care Physicians, PC Albany New York
United States NYOH Albany Cancer Center at Patroon Creek Albany New York
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
United States The Urology Center of Colorado Denver Colorado
United States Urology Center of Alabama Homewood Alabama
United States University of California San Diego / Moores Cancer Center La Jolla California
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Keck Hospital of USC Los Angeles California
United States LAC + USC Medical Center Los Angeles California
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States Grand Strand Urology Myrtle Beach South Carolina
United States Urology San Antonio Research San Antonio Texas
United States Seattle Cancer Care Alliance 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 Measure change in immune response to PA2024 by IFN-gamma production ELISPOT following sipuleucel-T/ADT treatment regimens. To determine whether ADT started before or after sipuleucel-T leads to superior augmentation of immune response to sipuleucel-T. Change in immune response from baseline through Month 24 No
Secondary Number of Participants with Adverse Events as a Measure of Safety From baseline up to 3 years Yes
Secondary Measure changes in immune responses over time Immune responses will be assessed from baseline through Month 24 by IFN-gamma ELISPOT assay, T cell proliferation assay, and production of antibodies (humoral response) to PAP and/or PA2024. From baseline through Month 24 No
Secondary Measure changes in sipuleucel-T product parameters: CD54 upregulation, number of CD54+ cells, and total nucleated cell number A course of sipuleucel-T therapy consists of 3 complete doses given at approximately 2-week intervals. Over the course of sipuleucel-T therapy (approximately 1 month) No
Secondary Measure changes in PSA over time From baseline through Month 27 No
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