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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Call Center 1-855-319-4021 PROSPECT@epharmasolutions.com
Contact: Jeannie Giacchino Jeannie.Giacchino@bavarian-nordic.com

  Show 190 Study Locations
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: May 7, 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 July 26, 2014