Know Cancer

forgot password

A Randomized, Open-label, Phase 2 Trial of Sipuleucel-T With Concurrent Versus Sequential Administration of Abiraterone Acetate Plus Prednisone in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer Metastatic, Hormone Refractory Prostate Cancer

Thank you

Trial Information

A Randomized, Open-label, Phase 2 Trial of Sipuleucel-T With Concurrent Versus Sequential Administration of Abiraterone Acetate Plus Prednisone in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Inclusion Criteria:

- historically documented prostate cancer confirmed by a pathology report from prostate
biopsy or radical prostatectomy specimen

- metastatic status as evidenced by imaging obtained demonstrating bone metastasis or lymph node metastasis

- castrate resistant prostate cancer: castrate levels of testosterone ( evidence of disease progression concomitant with surgical or medical castration

- serum PSA >/= 2.0 ng/mL

- castrate levels of testosterone ( castration

- baseline ECOG performance status of
- systolic blood pressure (BP)
- adequate baseline hematologic, renal, and liver functions

- must live in a permanent residence within a comfortable driving distance (roundtrip
within one day) of the clinical trial site

Exclusion Criteria:

- the presence of known lung, liver, or brain metastases, malignant pleural effusions,
or malignant ascites

- New York Heart Association Class III or IV heart failure

- any medical condition that may be compromised by increases in blood pressure,
hypokalemia, or fluid retention

- Child-Pugh Class B or C hepatic insufficiency

- spinal cord compression, imminent long bone fracture, or any other condition likely
to require radiation therapy and/or steroids for pain control

- known adrenalcortical insufficiency

- any medical contraindications to receiving prednisone

- prior treatment with sipuleucel-T

- previous treatment with abiraterone acetate (Zytiga(R)) or ipilimumab (Yervoy(TM))

- a requirement for systemic immunosuppressive therapy for any reason. Use of inhaled,
intra-nasal, intra-articular, and topical steroids is allowed.

- treatment with any investigational vaccine or immunotherapy

- 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.

- myocardial infarction or ventricular or atrial arrhythmia within 6 months prior to

- ongoing anti-androgen withdrawal response.

- systemic steroid use within ≤ 60 days of registration

- treatment with denosumab (Xgeva(R) or Prolia (R)) within ≤ 3 months prior to

- positive test for HIV or HTLV infections. Subjects with a positive test for
hepatitis B or hepatitis C are allowed provided they meet the LFT criteria and have
no signs of acute infection or active disease.

- treatment with any of the following medications or interventions within 28 days prior
to registration: external beam radiation or major surgery requiring general
anesthetic; saw palmetto; megestrol acetate (Megace(R)), diethylstilbestrol, and
cyproterone; 5-alpha-reductase inhibitors (e.g. finasteride [Proscar(R)], dutasteride
[Avodart(R)]); steroidal anti-androgen therapy; any other systemic therapy for
prostate cancer, except for medical castration; treatment with any other
investigational product for prostate cancer; substrates of CYP2D6 (e.g. including but
not limited to thioridazine); inhibitors of CYP3A4 (e.g. including but not limited to
ketoconazole, itraconazole, clarithromycin, nefazodone, telithromycin, and
voriconazole); inducers of CYP3A4 (e.g. including but not limited to phenytoin,
carbamazepine, rifampin, rifapentine, and phenobarbital)

- a requirement for treatment with opioid analgesics within 21 days prior to

- an active infection or infection requiring parenteral antibiotic therapy or causing
fever within 7 days of registration

- any medical intervention, or other condition, or any other circumstance that, in the
opinion of the Investigator or the Dendreon Medical Monitor, could compromise
adherence with study requirements or otherwise compromise the study's objectives

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Evaluate cumulative sipuleucel-T CD54 upregulation

Outcome Time Frame:

Over the course of sipuleucel-T therapy (approximately 1 month)

Safety Issue:


Principal Investigator

Andrew C Stubbs, PhD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

Related Keywords:

  • Prostate Cancer Metastatic
  • Hormone Refractory Prostate Cancer
  • prostate cancer
  • prostate
  • AIPC
  • androgen-independent
  • androgen independent
  • hormone insensitive
  • hormone-insensitive
  • PSA
  • prostatic adenocarcinoma
  • hormone-refractory
  • hormone refractory
  • HRPC
  • immune therapy
  • immunotherapy
  • vaccine
  • dendritic cells
  • antigen-presenting cells
  • antigen presenting cells
  • cancer vaccine
  • therapeutic vaccine
  • therapeutic cancer vaccine
  • recombinant
  • biological
  • biopharmaceutical
  • biotechnology
  • biotech
  • Prostatic Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary



Virginia Mason Medical Center Seattle, Washington  98111
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
Moores UCSD Cancer Center La Jolla, California  92093-0658
Indiana University Indianapolis, Indiana  46202
Sharp Rees-Stealy La Mesa, California  91942
Carolina Urologic Research Center Myrtle Beach, South Carolina  29572
Georgetown University Medical Center - Lombardi Cancer Center Washington, District of Columbia  20007
Medical Oncology Associates - SD San Diego, California  92123
Cancer Center Oncology Medical Group La Mesa, California  91942
The Urology Center of Colorado Denver, Colorado  80211
Urology of Virginia Newport News, Virginia  23606
The Mount Sinai Medical Center New York, New York  10029
UCSD Medical Center - Hillcrest San Diego, California  92103
Associated Medical Professionals of New York, PLLC Oneida, New York  13421
Providence Cancer Center Oncology and Hematology Care Portland, Oregon  97213
Urology Associates, P.C. Nashville, Tennessee  37209
UCSD Medical Center - La Jolla La Jolla, California  92037
GU Research Center, LLC Omaha, Nebraska  68130
NYU Clinical Cancer Center, NYU Langone Medical Center New York, New York  10016
Associated Medical Professionals of NY, PLLC Oneida, New York  13421
Mid Atlantic Urology Associates, Mid Atlantic Clinical Research Greenbelt, Maryland  20770