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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
N/A
Open (Enrolling)
Male
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.

OR

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:

Interventional

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:

No

Principal Investigator

James L. Gulley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Food and Drug Administration

Study ID:

BNIT-PRV-301

NCT ID:

NCT01322490

Start Date:

November 2011

Completion Date:

August 2016

Related Keywords:

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

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
Mayo ClinicRochester, Minnesota  55905
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Medical College of WisconsinMilwaukee, Wisconsin  53226
Virginia Mason Medical CenterSeattle, Washington  98111
Cedars-Sinai Medical CenterLos Angeles, California  90048
Scott and White Memorial HospitalTemple, Texas  76508
Greenville Hospital SystemGreenville, South Carolina  29605
Mount Nittany Medical CenterState College, Pennsylvania  16803
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Walter Reed Army Medical CenterSilver Spring, Maryland  20910
University of ColoradoDenver, Colorado  80217
St. Alexius Medical CenterBismarck, North Dakota  58502
Washington Cancer InstituteWashington, District of Columbia  20010
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Urology Clinics of North TexasDallas, Texas  75231
Sharp Memorial HospitalSan Diego, California  92123
Greater Baltimore Medical CenterBaltimore, Maryland  21204
Ochsner Cancer InstituteNew Orleans, Louisiana  70121
Union Memorial HospitalBaltimore, Maryland  21218
Willamette Valley Cancer CenterEugene, Oregon  97401-8122
South Florida Medical ResearchAventura, Florida  33180
North Idaho UrologyCouer D'Alene, Idaho  83814
Lakeland Regional Cancer CenterLakeland, Florida  33805
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Alaska Clinical Research Center, LLCAnchorage, Alaska  99508
Pinellas Urology, Inc.St. Petersburg, Florida  33710
Urological Associates Of LancasterLancaster, Pennsylvania  17604-3200
University Of Cincinnati Medical CenterCincinnati,, Ohio  45267-0589
WJB Dorn VA Medical CenterColumbia, South Carolina  29209
Gabrail Cancer CenterCanton, Ohio  44718
San Bernardino Urological AssociatesSan Bernardino, California  
Northeast Urology ResearchConcord, North Carolina  28025
Presbyterian Hospital Center for Cancer ResearchCharlotte, North Carolina  28204
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
Stanford Advanced Medical CenterStanford, California  94305-5826
National Cancer Institute - Center for Cancer ResearchBethesda, Maryland  
Columbus Urology ResearchColumbus, Ohio  43214
Durham VA Medical CenterDurham, North Carolina  27705
Kansas City VA Medical CenterKansas City, Missouri  64128
Urology Associates, PCNashville, Tennessee  37209
University Urology AssociatesNew York, New York  10016
Brooklyn Urology Research GroupBrooklyn, New York  11215
Tulane UniversityNew Orleans, Louisiana  70112-2699
San Diego Clinical TrialsSan Diego, California  92120
The Urology Center of ColoradoDenver, Colorado  80211
Alta Bates Summit Medical CenterBerkeley, California  94704
Regional Cancer Care PADurham, North Carolina  
Florida Urology PhysiciansFort Myers, Florida  
Myron Murdock M.D. LLCGreenbelt, Maryland  
VA Sierra Nevada Healthcare SystemReno, Nevada  89502
Manatee Medical Research Institute, LLCBradenton, Florida  34205
First Urology PSCJeffersonville, Indiana  47130
The Iowa Clinic, PC Iowa UrologyWest Des Moines, Iowa  50266
GU Research Network, LLCOmaha, Nebraska  68130
Hudson Valley Urology, P.C.Poughkeepsie, New York  12601
Urologic Consultants of Southeaster PA LLPBala Cynwyd, Pennsylvania  19004
The Schiffler Cancer CenterWheeling, West Virginia  26003
W.G. (Bill) Hefner VA Medical CenterSalisbury, North Carolina  28144
Ralph H Johnson VAMCCharleston, South Carolina  29401
James H. Quillen Veterans Affairs Medical CenterMountain Home, Tennessee  37684
White River Junction Veterans Affairs Medical CenterWhite River Junction, Vermont  05009