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. (see Contacts and Locations)
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: May 7, 2014
Last verified: January 2014

March 23, 2011
May 7, 2014
November 2011
December 2015   (final data collection date for primary outcome measure)
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.
Overall survival [ Time Frame: Survival will be assessed over the life of the study or approximately 5 years. ] [ Designated as safety issue: No ]
Overall survival will be measured for all patients until the required number of events per comparison arm is reached (approximately 534 events per comparison arm).
Complete list of historical versions of study NCT01322490 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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
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

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.

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Prostate Cancer Metastatic
  • Biological: PROSTVAC-V
  • Biological: PROSTVAC-F
  • Drug: GM-CSF
  • Other: GM-CSF Placebo
  • Biological: Placebo
    PROSTVAC V/F Placebo
  • Experimental: PROSTVAC-V/F-TRICOM + GM-CSF
    • PROSTVAC-V-TRICOM
    • PROSTVAC-F-TRICOM
    • GM-CSF
    Interventions:
    • 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
    Interventions:
    • Biological: PROSTVAC-V
    • Biological: PROSTVAC-F
    • Other: GM-CSF Placebo
  • Placebo Comparator: Placebo Control
    PROSTVAC V/F Placebo + GM-CSF Placebo
    Interventions:
    • Other: GM-CSF Placebo
    • Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
August 2016
December 2015   (final data collection date for primary outcome measure)

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.

Male
18 Years and older
No
Contact: Call Center 1-855-319-4021 PROSPECT@epharmasolutions.com
Contact: Jeannie Giacchino Jeannie.Giacchino@bavarian-nordic.com
United States,   Australia,   Belgium,   Canada,   Denmark,   Estonia,   France,   Germany,   Iceland,   Israel,   Netherlands,   Poland,   Puerto Rico,   Russian Federation,   Spain,   United Kingdom
 
NCT01322490
BNIT-PRV-301
Yes
Bavarian Nordic, Inc.
Bavarian Nordic, Inc.
Not Provided
Principal Investigator: James L. Gulley, MD National Cancer Institute (NCI)
Principal Investigator: Philip Kantoff, MD Dana-Farber Cancer Institute
Bavarian Nordic, Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP