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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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostatic Neoplasm, Prostate Cancer, Prostatic Adenocarcinoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Measure change in immune response to PA2024 by IFN-gamma production ELISPOT following sipuleucel-T/ADT treatment regimens.

Outcome Description:

To determine whether ADT started before or after sipuleucel-T leads to superior augmentation of immune response to sipuleucel-T.

Outcome Time Frame:

Change in immune response from baseline through Month 24

Safety Issue:

No

Principal Investigator

Candice McCoy, MD

Investigator Role:

Study Director

Investigator Affiliation:

Dendreon

Authority:

United States: Food and Drug Administration

Study ID:

P10-2

NCT ID:

NCT01431391

Start Date:

September 2011

Completion Date:

August 2014

Related Keywords:

  • Prostatic Neoplasm
  • Prostate Cancer
  • Prostatic Adenocarcinoma
  • 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
  • LHRH
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

Virginia Mason Medical CenterSeattle, Washington  98111
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Urology San Antonio ResearchSan Antonio, Texas  78229
Seattle Cancer Care AllianceSeattle, Washington  98109
Grand Strand UrologyMyrtle Beach, South Carolina  29572
The Urology Center of ColoradoDenver, Colorado  80211
USC / Norris Comprehensive Cancer CenterLos Angeles, California  90033
Premier Medical Group of the Hudson ValleyPoughkeepsie, New York  12601
Urology Center of AlabamaHomewood, Alabama  35209
University of California San Diego / Moores Cancer CenterLa Jolla, California  91914
LAC + USC Medical CenterLos Angeles, California  90033
Keck Hospital of USCLos Angeles, California  90033
Community Care Physicians, PCAlbany, New York  12208
NYOH Albany Cancer Center at Patroon CreekAlbany, New York  12206