Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Randomized, Open-Label, Phase 2 Trial Examining the Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men With Non-metastatic Prostate Cancer and a Rising Serum Prostate Specific Antigen After Primary Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431391
• Other study ID #: P10-2
• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Cancer
• Prostatic Adenocarcinoma
• Prostatic Neoplasm
• Prostatic Neoplasms

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