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

NCT01431391 | Completed Phase 2 Results

• 1 other identifier: P10-2
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Prostatic Neoplasm; Prostate Cancer; Prostatic Adenocarcinoma

Keywords

Immune therapy; Cancer vaccine; Therapeutic vaccine; Therapeutic cancer vaccine; Vaccine; Dendritic cells; PSA; Androgen deprivation therapy; Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms; Prostatic Diseases; Androgens; Hormones; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Immunology; Hormone therapy; Immunotherapy; Luteinizing hormone-releasing hormone (LHRH)

Outcome Measures

Primary Outcomes (1)

• Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024

  Immune response at month 24 as evaluated by IFN-γ ELISPOT specific for PA2024 following sipuleucel-T/ADT treatment regimens to determine if order of administration impacted immune response.

  PA2024 ELISPOT counts at Month 24

Secondary Outcomes (1)

• Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024

  Month 24

Study Arms (2)

Arm 1: Sipuleucel-T followed by ADT

EXPERIMENTAL

Arm 1: Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.

Biological: sipuleucel-T; Drug: leuprolide acetate

Arm 2: ADT followed by sipuleucel-T

EXPERIMENTAL

Arm 2: Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.

Biological: sipuleucel-T; Drug: leuprolide acetate

Interventions

sipuleucel-T BIOLOGICAL

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).

Also known as: PROVENGE®, APC8015

Arm 1: Sipuleucel-T followed by ADT; Arm 2: ADT followed by sipuleucel-T

leuprolide acetate DRUG

45.0 mg depot injection, 2 doses 6 months apart

Also known as: Eligard®

Arm 1: Sipuleucel-T followed by ADT; Arm 2: ADT followed by sipuleucel-T

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hormone-sensitive prostate cancer
• Non-metastatic disease, as evidenced by negative bone scan or computed tomography of the abdomen and pelvis
• ECOG performance status ≤ 1
• Histologically documented prostate cancer
• Prior primary therapy for prostate cancer
• Rising PSA with a PSADT of ≤ 12 months
• 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 (round-trip within one day) to the clinical research site

You may not qualify if:

• 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 ≥ 6 months duration in total
• If subject has a history of any other stage III/IV malignancy, the subject must be disease free and off any malignancy-related treatment for at least 10 years. If the subject has a history of any stage I-II malignancy, the subject must be disease free and off any malignancy-related treatment for at least 5 years.
• Prior experimental immunotherapy or on an experimental clinical trial 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
• Any medical intervention, any other condition, or any circumstances that could compromise the study.

Sponsors & Collaborators

• Dendreon: lead

Study Sites (14)

Urology Center of Alabama

Homewood, Alabama, 35209, United States

Location

University of California San Diego / Moores Cancer Center

La Jolla, California, 91914, United States

Location

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

LAC + USC Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

The Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

NYOH Albany Cancer Center at Patroon Creek

Albany, New York, 12206, United States

Location

Community Care Physicians, PC

Albany, New York, 12208, United States

Location

Grand Strand Urology

Myrtle Beach, South Carolina, 29572, United States

Location

Urology San Antonio Research

San Antonio, Texas, 78229, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms; Prostatic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Interventions

sipuleucel-T; Leuprolide; luprolide acetate gel depot

Condition Hierarchy (Ancestors)

Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Shabnam Vaziri
• Organization: Dendreon

svaziri@dendreon.com

206-455-2323

Study Officials

• Robert Israel, MD

  Valeant Pharmaceuticals North America LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: September 9, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 30, 2017
• Results First Posted: May 30, 2017

Record last verified: 2017-04

Locations

US (14)