Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01322490
Registration number
NCT01322490
Ethics application status
Date submitted
23/03/2011
Date registered
24/03/2011
Date last updated
4/09/2019
Titles & IDs
Public 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
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
BNIT-PRV-301
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Prospect
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer Metastatic
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Prostate
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - PROSTVAC-V
Other interventions - PROSTVAC-F
Treatment: Drugs - GM-CSF
Other interventions - GM-CSF Placebo
Other interventions - Placebo
Experimental: PROSTVAC-V/F-TRICOM + GM-CSF - PROSTVAC-V-TRICOM
PROSTVAC-F-TRICOM
GM-CSF
Experimental: PROSTVAC-V/F-TRICOM + GM-CSF placebo - PROSTVAC-V-TRICOM
PROSTVAC-F-TRICOM
GM-CSF placebo
Placebo Comparator: Placebo Control - PROSTVAC V/F Placebo + GM-CSF Placebo
Other interventions: PROSTVAC-V
Other interventions: PROSTVAC-F
Treatment: Drugs: GM-CSF
Other interventions: GM-CSF Placebo
Other interventions: Placebo
PROSTVAC V/F Placebo
Query!
Intervention code [1]
0
0
Other interventions
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall Survival
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
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.
Query!
Secondary outcome [1]
0
0
Number of Subjects Alive Without Event at 6 Months
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Randomization through Week 25/End of Treatment visit.
Query!
Eligibility
Key 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).
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
28/11/2011
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
15/12/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1297
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Sydney Haematology and Oncology Clinic - St Leonards
Query!
Recruitment hospital [2]
0
0
Calvary Mater Newcastle - Waratah
Query!
Recruitment hospital [3]
0
0
Redcliffe Hospital - Redcliffe
Query!
Recruitment hospital [4]
0
0
Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [5]
0
0
Austin Hospital - Heidelberg
Query!
Recruitment hospital [6]
0
0
Monash Medical Centre - Moorabbin Campus - Bentleigh East
Query!
Recruitment hospital [7]
0
0
Barwon Health - Geelong
Query!
Recruitment hospital [8]
0
0
St John of God Hospital - Subiaco
Query!
Recruitment hospital [9]
0
0
Border Medical Oncology - Wodonga
Query!
Recruitment hospital [10]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [2]
0
0
2298 - Waratah
Query!
Recruitment postcode(s) [3]
0
0
4020 - Redcliffe
Query!
Recruitment postcode(s) [4]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [5]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [6]
0
0
3165 - Bentleigh East
Query!
Recruitment postcode(s) [7]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [8]
0
0
6008 - Subiaco
Query!
Recruitment postcode(s) [9]
0
0
3690 - Wodonga
Query!
Recruitment postcode(s) [10]
0
0
4102 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alaska
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
District of Columbia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Idaho
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Iowa
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Louisiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Massachusetts
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Minnesota
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Missouri
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nebraska
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Nevada
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New Jersey
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New York
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
North Carolina
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
North Dakota
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Ohio
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Oregon
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Pennsylvania
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
South Carolina
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Tennessee
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Texas
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Utah
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Vermont
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Virginia
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Washington
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
West Virginia
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Wisconsin
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Antwerp
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Brussels
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Bruxelles
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Gent
Query!
Country [38]
0
0
Belgium
Query!
State/province [38]
0
0
Leuven
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
Roeselare
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
British Columbia
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Nova Scotia
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Ontario
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Quebec
Query!
Country [44]
0
0
Denmark
Query!
State/province [44]
0
0
Aalborg
Query!
Country [45]
0
0
Denmark
Query!
State/province [45]
0
0
Copenhagen
Query!
Country [46]
0
0
Denmark
Query!
State/province [46]
0
0
Frederiksberg
Query!
Country [47]
0
0
Denmark
Query!
State/province [47]
0
0
Herlev
Query!
Country [48]
0
0
Denmark
Query!
State/province [48]
0
0
Holstebro
Query!
Country [49]
0
0
Denmark
Query!
State/province [49]
0
0
Næstved
Query!
Country [50]
0
0
Denmark
Query!
State/province [50]
0
0
Århus N
Query!
Country [51]
0
0
Estonia
Query!
State/province [51]
0
0
Tallinn
Query!
Country [52]
0
0
Estonia
Query!
State/province [52]
0
0
Tartu
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Angers
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
La Roche Sur Yon
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Lyon
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Nancy
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Paris
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Pierre Benite
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Reims
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Saint Brieuc
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Tours
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Vandoeuvre les Nancy
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Bavaria
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Bonn
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Essen
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Frankfurt
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Freiburg
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Hamburg
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Jena
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Mainz
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Marburg
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Reutlingen
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Tübingen
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Ulm
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Würzburg
Query!
Country [76]
0
0
Iceland
Query!
State/province [76]
0
0
Reykjavik
Query!
Country [77]
0
0
Israel
Query!
State/province [77]
0
0
Beer Sheva
Query!
Country [78]
0
0
Israel
Query!
State/province [78]
0
0
Haifa
Query!
Country [79]
0
0
Israel
Query!
State/province [79]
0
0
Holon
Query!
Country [80]
0
0
Israel
Query!
State/province [80]
0
0
Jerusalem
Query!
Country [81]
0
0
Israel
Query!
State/province [81]
0
0
Ramat-Gan
Query!
Country [82]
0
0
Israel
Query!
State/province [82]
0
0
Tzrifin
Query!
Country [83]
0
0
Netherlands
Query!
State/province [83]
0
0
Amsterdam
Query!
Country [84]
0
0
Netherlands
Query!
State/province [84]
0
0
Maastricht
Query!
Country [85]
0
0
Netherlands
Query!
State/province [85]
0
0
Nijmegen
Query!
Country [86]
0
0
Netherlands
Query!
State/province [86]
0
0
Rotterdam
Query!
Country [87]
0
0
Poland
Query!
State/province [87]
0
0
Grodzisk Mazowiecki
Query!
Country [88]
0
0
Poland
Query!
State/province [88]
0
0
Siedlce
Query!
Country [89]
0
0
Poland
Query!
State/province [89]
0
0
Warsaw
Query!
Country [90]
0
0
Poland
Query!
State/province [90]
0
0
Wroclaw
Query!
Country [91]
0
0
Puerto Rico
Query!
State/province [91]
0
0
Ponce
Query!
Country [92]
0
0
Puerto Rico
Query!
State/province [92]
0
0
San Juan
Query!
Country [93]
0
0
Russian Federation
Query!
State/province [93]
0
0
Arkhangelsk
Query!
Country [94]
0
0
Russian Federation
Query!
State/province [94]
0
0
Chelyabinsk
Query!
Country [95]
0
0
Russian Federation
Query!
State/province [95]
0
0
Kazan
Query!
Country [96]
0
0
Russian Federation
Query!
State/province [96]
0
0
Moscow
Query!
Country [97]
0
0
Russian Federation
Query!
State/province [97]
0
0
Omsk
Query!
Country [98]
0
0
Russian Federation
Query!
State/province [98]
0
0
Orel
Query!
Country [99]
0
0
Russian Federation
Query!
State/province [99]
0
0
Orenburg
Query!
Country [100]
0
0
Russian Federation
Query!
State/province [100]
0
0
St. Petersburg
Query!
Country [101]
0
0
Russian Federation
Query!
State/province [101]
0
0
St.Petersburg
Query!
Country [102]
0
0
Russian Federation
Query!
State/province [102]
0
0
Stavropol
Query!
Country [103]
0
0
Russian Federation
Query!
State/province [103]
0
0
Vladimir
Query!
Country [104]
0
0
Russian Federation
Query!
State/province [104]
0
0
Yaroslavl
Query!
Country [105]
0
0
Spain
Query!
State/province [105]
0
0
Galicia
Query!
Country [106]
0
0
Spain
Query!
State/province [106]
0
0
Madrid, Communidad De
Query!
Country [107]
0
0
Spain
Query!
State/province [107]
0
0
Navarra
Query!
Country [108]
0
0
Spain
Query!
State/province [108]
0
0
Avila
Query!
Country [109]
0
0
Spain
Query!
State/province [109]
0
0
Barcelona
Query!
Country [110]
0
0
Spain
Query!
State/province [110]
0
0
Córdoba
Query!
Country [111]
0
0
Spain
Query!
State/province [111]
0
0
Elche
Query!
Country [112]
0
0
Spain
Query!
State/province [112]
0
0
Madrid
Query!
Country [113]
0
0
Spain
Query!
State/province [113]
0
0
Majadahonda
Query!
Country [114]
0
0
Spain
Query!
State/province [114]
0
0
Manresa
Query!
Country [115]
0
0
Spain
Query!
State/province [115]
0
0
Málaga
Query!
Country [116]
0
0
Spain
Query!
State/province [116]
0
0
Palma de Mallorca
Query!
Country [117]
0
0
Spain
Query!
State/province [117]
0
0
Pamplona
Query!
Country [118]
0
0
Spain
Query!
State/province [118]
0
0
Sabadell
Query!
Country [119]
0
0
Spain
Query!
State/province [119]
0
0
Sevilla
Query!
Country [120]
0
0
Spain
Query!
State/province [120]
0
0
Terrassa
Query!
Country [121]
0
0
Spain
Query!
State/province [121]
0
0
Zaragoza
Query!
Country [122]
0
0
United Kingdom
Query!
State/province [122]
0
0
UK
Query!
Country [123]
0
0
United Kingdom
Query!
State/province [123]
0
0
Birmingham
Query!
Country [124]
0
0
United Kingdom
Query!
State/province [124]
0
0
Cardiff
Query!
Country [125]
0
0
United Kingdom
Query!
State/province [125]
0
0
Glasgow
Query!
Country [126]
0
0
United Kingdom
Query!
State/province [126]
0
0
Guildford
Query!
Country [127]
0
0
United Kingdom
Query!
State/province [127]
0
0
Leeds
Query!
Country [128]
0
0
United Kingdom
Query!
State/province [128]
0
0
London
Query!
Country [129]
0
0
United Kingdom
Query!
State/province [129]
0
0
Manchester
Query!
Country [130]
0
0
United Kingdom
Query!
State/province [130]
0
0
Plymouth
Query!
Country [131]
0
0
United Kingdom
Query!
State/province [131]
0
0
Southampton
Query!
Country [132]
0
0
United Kingdom
Query!
State/province [132]
0
0
Sutton
Query!
Country [133]
0
0
United Kingdom
Query!
State/province [133]
0
0
Wirral
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bavarian Nordic
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01322490
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
James L. Gulley, MD
Query!
Address
0
0
National Cancer Institute (NCI)
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01322490
Download to PDF