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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 (Prospect)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01322490
First Posted: March 24, 2011
Last Update Posted: August 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bavarian Nordic, Inc.
March 23, 2011
March 24, 2011
August 16, 2017
November 28, 2011
November 2017   (Final data collection date for primary outcome measure)
Overall survival [ Time Frame: Survival will be assessed over the life of the study ]
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. ]
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 ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
 
Active, not recruiting
1298
November 2018
November 2017   (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.

Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   Denmark,   Estonia,   France,   Germany,   Iceland,   Israel,   Netherlands,   Poland,   Puerto Rico,   Russian Federation,   Spain,   United Kingdom,   United States
 
 
NCT01322490
BNIT-PRV-301
Yes
Not Provided
Not Provided
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.
August 2017

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