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A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer

Phase 3
18 Years
Open (Enrolling)
Prostate Cancer Metastatic

Thank you

Trial Information

A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer

BNIT-PRV-301 is a randomized, placebo-controlled, multi-center, global Phase 3 efficacy
trial of PROSTVAC in men with asymptomatic or minimally symptomatic, metastatic,
castrate-resistant prostate cancer. It is a 3-arm study and will evaluate overall survival
in two separate comparisons, PROSTVAC plus adjuvant dose GM-CSF versus controls, and
PROSTVAC without GM-CSF versus controls.

Patients will be randomized with equal probability into one of three double-blind arms. The
intended interventions for randomized patients are:

1. (Arm V+G) PROSTVAC-V/F plus adjuvant dose GM-CSF

2. (Arm V) PROSTVAC-V/F plus GM-CSF placebo

3. (Arm P) Double placebo

Inclusion Criteria:

Men, ≥18years of age with documented asymptomatic or minimally symptomatic metastatic
castration-resistant prostate cancer.

Documented progressive disease post surgical castration or during androgen suppression
therapy, or during complete androgen blockade therapy and withdrawal. Documented by either
criterion a (Radiological progression), OR criterion b (PSA progression).

1. Radiological progression defined as any new/enlarging bone metastases or
new/enlarging lymph node disease, consistent with prostate cancer.


2. PSA progression defined by sequence of rising values separated by > 1 week (2
separate increasing values) over a threshold minimum of 2.0 ng/ml. (PCWG2 PSA
eligibility criteria).

Chemotherapy naïve and Vaccinia-experienced (previous smallpox vaccination). Currently
using a GnRH agonist or antagonist (unless surgically castrated).

Exclusion Criteria:

Cancer-related pain requiring scheduled opioid narcotics for control (as needed, ≤ 2x per
week is allowed).

Metastasis to organ systems other than lymph nodes and/or bone. Estimated PSA doubling
time of <1 month as established within 6 months of the anticipated first dose of vaccine
or placebo.

Concurrent or prior Provenge (sipuleucel-T) immunotherapy for prostate cancer. Receipt of
an investigational agent within 30 days (or 60 days for an antibody-based therapy) of the
first planned dose of PROSTVAC-V/F.

History of prior malignancies other than prostate cancer within the past 3 years,
excluding successfully resected basal or squamous cell carcinoma of the skin.

Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or
hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or
myocardial infarction (current or within the past 6 months) Confirmed positive for HIV,
hepatitis B, and /or hepatitis C. Immunodeficiency or splenectomy. History of or active
autoimmune disease, persons with vitiligo are not excluded. Diabetics are not excluded if
the condition is well controlled.

History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that
disrupts the epidermis.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

Overall survival will be measured for all patients until the required number of events per comparison arm is reached.

Outcome Time Frame:

Survival will be assessed over the life of the study

Safety Issue:


Principal Investigator

James L. Gulley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

August 2016

Related Keywords:

  • Prostate Cancer Metastatic
  • metastatic
  • prostate cancer
  • castrate-resistant
  • vaccine
  • immunotherapy
  • Phase 3
  • Prostatic Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary



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