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 (Prospect)

This study is currently recruiting participants.
Verified January 2014 by Bavarian Nordic, Inc.
Sponsor:
Information provided by (Responsible Party):
Bavarian Nordic, Inc.
ClinicalTrials.gov Identifier:
NCT01322490
First received: March 23, 2011
Last updated: February 12, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.


Condition Intervention Phase
Prostate Cancer Metastatic
Biological: PROSTVAC-V
Biological: PROSTVAC-F
Drug: GM-CSF
Other: GM-CSF Placebo
Biological: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Bavarian Nordic, Inc.:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Survival will be assessed over the life of the study ] [ Designated as safety issue: No ]
    Overall survival will be measured for all patients until the required number of events per comparison arm is reached.


Secondary Outcome Measures:
  • Proportion of event-free patients compared with placebo [ Time Frame: Events will be measured at baseline and 6 months ] [ Designated as safety issue: No ]
    This endpoint will measure the proportion of patients receiving PROSTVAC with or without GM-CSF who remain event-free (radiological progression, pain progression, initiation of chemotherapy, or death) at 6 months compared to placebo.


Estimated Enrollment: 1200
Study Start Date: November 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PROSTVAC-V/F-TRICOM + GM-CSF
  • PROSTVAC-V-TRICOM
  • PROSTVAC-F-TRICOM
  • GM-CSF
Biological: PROSTVAC-V Biological: PROSTVAC-F Drug: GM-CSF
Experimental: PROSTVAC-V/F-TRICOM + GM-CSF placebo
  • PROSTVAC-V-TRICOM
  • PROSTVAC-F-TRICOM
  • GM-CSF placebo
Biological: PROSTVAC-V Biological: PROSTVAC-F Other: GM-CSF Placebo
Placebo Comparator: Placebo Control
PROSTVAC V/F Placebo + GM-CSF Placebo
Other: GM-CSF Placebo Biological: Placebo
PROSTVAC V/F Placebo

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322490

Contacts
Contact: Paul Collins paul.collins@ppdi.com
Contact: Janet Hurt janet.hurt@bavarian-nordic.com

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Locations
United States, Alaska
Alaska Clinical Research Center, Llc Recruiting
Anchorage, Alaska, United States, 99508
Contact    907-276-1455      
United States, California
Alta Bates Summit Medical Center Recruiting
Berkeley, California, United States, 94704
Contact    510-204-3428      
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact    310-423-3713      
San Bernardino Urological Associates Recruiting
San Bernardino, California, United States, 92404
Contact    909-881-0555      
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact    858-939-5062      
San Diego Clinical Trials Recruiting
San Diego, California, United States, 92120
Contact    619-287-6000      
VA San Diego Healthcare System Recruiting
San Diego, California, United States, 92161
Contact    858-552-8585 ext 7521      
Stanford Advanced Medical Center Recruiting
Stanford, California, United States, 94305
Contact    650-736-1252      
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact    720-848-0632      
The Urology Center of Colorado Recruiting
Denver, Colorado, United States, 80211
Contact    303-421-5783      
United States, District of Columbia
Washington Cancer Institute Recruiting
Washington, District of Columbia, United States, 20010
Contact    202-877-6998      
United States, Florida
South Florida Medical Research Recruiting
Aventura, Florida, United States, 33180
Contact    305-931-8080      
Manatee Medical Research Institute, LLC Recruiting
Bradenton, Florida, United States, 34205
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Florida Urology Physicians Recruiting
Fort Myers, Florida, United States, 33908
Contact    239-689-8800      
Lakeland Regional Cancer Center Recruiting
Lakeland, Florida, United States, 33805
Contact    863-904-1900      
Pinellas Urology, Inc. Recruiting
St. Petersberg, Florida, United States, 33710
Contact    727-341-1583      
James A Haley Veteran Affairs Medical Center Recruiting
Tampa, Florida, United States, 33612
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West Palm Beach, Florida, United States, 33401
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Coeur d'Alene, Idaho, United States, 83814
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Chicago, Illinois, United States, 60612
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Baltimore, Maryland, United States, 21218
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Maryland Prostate Center Recruiting
Baltimore, Maryland, United States, 21201
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Bethesda, Maryland, United States, 20892
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Brooklyn, New York, United States, 11215
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Willamette Valley Cancer Center Recruiting
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University of Utah Recruiting
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Tacoma, Washington, United States, 98431
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Medical College of Wisconsin Recruiting
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Brantford Urology Research Recruiting
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Siedlce, Poland, 08-110
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Warsaw, Poland, 04-749
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Ponce, Puerto Rico, 00716
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Russian Federation
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Chelyabinsk, Russian Federation, 454087
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Kazan State Medical University Recruiting
Kazan, Russian Federation, 420111
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Moscow, Russian Federation, 125248
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Omsk, Russian Federation, 644013
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Orel, Russian Federation, 302020
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Orenburg, Russian Federation, 460021
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St. Petersburg Medical Academy of Postgraduate Education Recruiting
St. Petersburg, Russian Federation, 191015
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St. Petersburg, Russian Federation, 197022
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"Orkli" LLC Recruiting
St. Petersburg, Russian Federation, 199178
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City Hospital #15 Recruiting
St. Petersburg, Russian Federation, 198205
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"Clinic Andros" LLC Recruiting
St.Petersburg, Russian Federation, 197136
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Stavropol, Russian Federation, 355047
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Yaroslavl, Russian Federation, 150040
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Madrid, Madrid, Communidad de, Spain, 28041
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Alcorcón, Spain, 28922
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Avila, Spain, 05004
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Barcelona, Spain, 08003
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Barcelona, Spain, 08035
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Córdoba, Spain, 14004
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Elche, Spain, 03203
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La Coruña, Spain, 15006
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Madrid, Spain, 28050
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Madrid, Spain, 28007
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Madrid, Spain, 28033
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Majadahonda, Spain, 28222
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Manresa, Spain, 08243
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Palma de Mallorca, Spain, 07198
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Sabadell, Spain, 08208
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Contact    +44 (0) 141 301 7221      
University of Surrey Recruiting
Guildford, United Kingdom, GU2 7XP
Contact    +44 1483 686074      
St James's Institute of Clinical Oncology Recruiting
Leeds, United Kingdom, LS9 7TF
Contact    +44 (0)1132068360      
St Mary's Hospital Recruiting
London, United Kingdom, W2 1NY
Contact    +44 203 31 22493      
The Royal Marsden Recruiting
London, United Kingdom, SW3 6JJ
Contact    +44 20 7811 8116      
St Bartholomews Hospital Recruiting
London, United Kingdom, EC1M 6BQ
Contact    +44 (0)20 7882 5958      
Christie Hospital Recruiting
Manchester, United Kingdom, M20 4BX
Contact    +44 0161 918 7345      
Derriford Hospital Recruiting
Plymouth, United Kingdom, PL6 8DH
Contact    +441752431960      
University of Southampton Recruiting
Southampton, United Kingdom, SO16 6YD
Contact    +44 2380 798785      
Royal Marsden Hospital Recruiting
Sutton, United Kingdom, SM2 5PT
Contact    +44(0) 208 661 3434      
The Clatterbridge Cancer Centre NHS Foundation Trust Recruiting
Wirral, United Kingdom, CH63 4JY
Contact    +441513341155 ext 5731      
Sponsors and Collaborators
Bavarian Nordic, Inc.
Investigators
Principal Investigator: James L. Gulley, MD National Cancer Institute (NCI)
Principal Investigator: Philip Kantoff, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Bavarian Nordic, Inc.
ClinicalTrials.gov Identifier: NCT01322490     History of Changes
Other Study ID Numbers: BNIT-PRV-301
Study First Received: March 23, 2011
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bavarian Nordic, Inc.:
PROSTVAC
metastatic
prostate cancer
castrate-resistant
vaccine
immunotherapy
Phase 3

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014