Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004418

Trial Description

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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

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Trial Acronym

Prospect

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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

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Organizational Data

  •   DRKS00004418
  •   2012/12/05
  •   2011/03/23
  •   no
  •   [---]*
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Secondary IDs

  •   NCT01322490  (ClinicalTrials.gov)
  •   BNIT-PRV-301  (BN ImmunoTherapeutics)
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Health Condition or Problem studied

  •   Prostate Cancer Metastatic
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Biological: PROSTVAC-V
  •   Biological: PROSTVAC-F
  •   Drug: GM-CSF
  •   Other: GM-CSF Placebo
  •   Biological: Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- 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.

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Secondary Outcome

- 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.

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Countries of Recruitment

  •   United States
  •   Australia
  •   Belgium
  •   Canada
  •   Denmark
  •   Estonia
  •   France
  •   Germany
  •   Iceland
  •   Israel
  •   Netherlands
  •   Poland
  •   Puerto Rico
  •   Russian Federation
  •   Spain
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2011/12/31
  •   1200
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional 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).

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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.

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Addresses

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    • Bavarian Nordic, Inc.
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    • National Cancer Institute (NCI)
    • James L. Gulley, MD 
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    • National Cancer Institute (NCI)
    • James L. Gulley, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   44
  •   2016/04/10


* This entry means the parameter is not applicable or has not been set.