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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)

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ClinicalTrials.gov Identifier: NCT01322490
Recruitment Status : Completed
First Posted : March 24, 2011
Results First Posted : August 8, 2019
Last Update Posted : September 4, 2019
Information provided by (Responsible Party):
Bavarian Nordic

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Metastatic Biological: PROSTVAC-V Biological: PROSTVAC-F Drug: GM-CSF Other: GM-CSF Placebo Biological: Placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1297 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : November 28, 2011
Actual Primary Completion Date : September 25, 2017
Actual Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
  • GM-CSF
Biological: PROSTVAC-V
Biological: PROSTVAC-F
Drug: GM-CSF
Experimental: PROSTVAC-V/F-TRICOM + GM-CSF placebo
  • 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

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Randomization through the date of death due to any cause. Subjects were followed up for approximately 6 years from the first subject randomized to the completion of the study. ]
    The time between the date of randomization and the date of death due to any cause. Subjects who did not experience death or the competing events of "definite" loss to follow-up or withdrawal of consent were right censored at the date of last contact. OS was calculated using the formula: OS = Date of death/competing event/censoring - date of randomization + 1.

Secondary Outcome Measures :
  1. Number of Subjects Alive Without Event at 6 Months [ Time Frame: Randomization through Week 25/End of Treatment visit. ]

    A binary assessment that was performed for the 6-months timepoint for the categories of radiographic progression, pain progression, initiation of chemotherapy or death. Subjects without an event prior to 6-months were evaluated at 6-months. Subjects without event by 6-months and were not evaluated at 6-months were assumed to have had an event and analyzed as such.

    Progression events were defined as: (1) Two new lesions on bone scan, new metastases on CT scans, or an increased size of nodal lesions per RECIST 1.1. Bone or CT scans occurring prior to calendar month 6 were used to determine radiographic progression. (2) Introduction of scheduled opioid narcotics for cancer-related pain control. (3) Initiation of chemotherapy for prostate cancer was assessed as collected on progression forms as well as in cancer treatment and concomitant medications logs. (4) Death.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.


  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322490

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Sponsors and Collaborators
Bavarian Nordic
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Principal Investigator: James L. Gulley, MD National Cancer Institute (NCI)
Principal Investigator: Philip Kantoff, MD Dana-Farber Cancer Institute
  Study Documents (Full-Text)

Documents provided by Bavarian Nordic:
Statistical Analysis Plan  [PDF] June 29, 2015
Study Protocol  [PDF] February 8, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bavarian Nordic
ClinicalTrials.gov Identifier: NCT01322490    
Other Study ID Numbers: BNIT-PRV-301
First Posted: March 24, 2011    Key Record Dates
Results First Posted: August 8, 2019
Last Update Posted: September 4, 2019
Last Verified: August 2019
Keywords provided by Bavarian Nordic:
prostate cancer
Phase 3
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents