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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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
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Secondary ID [1]
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BNIT-PRV-301
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Universal Trial Number (UTN)
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Trial acronym
Prospect
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer Metastatic
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Condition category
Condition code
Cancer
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0
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - 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
Treatment: Other: Placebo
PROSTVAC V/F Placebo
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival
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Assessment method [1]
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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.
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Timepoint [1]
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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.
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Secondary outcome [1]
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Number of Subjects Alive Without Event at 6 Months
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Assessment method [1]
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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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Timepoint [1]
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Randomization through Week 25/End of Treatment visit.
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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).
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Minimum age
18
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/11/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/12/2017
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Sample size
Target
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Accrual to date
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Final
1297
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Sydney Haematology and Oncology Clinic - St Leonards
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Calvary Mater Newcastle - Waratah
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Redcliffe Hospital - Redcliffe
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Royal Adelaide Hospital - Adelaide
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Austin Hospital - Heidelberg
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Monash Medical Centre - Moorabbin Campus - Bentleigh East
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Barwon Health - Geelong
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St John of God Hospital - Subiaco
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Border Medical Oncology - Wodonga
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Princess Alexandra Hospital - Woolloongabba
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2065 - St Leonards
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2298 - Waratah
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4020 - Redcliffe
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5000 - Adelaide
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3084 - Heidelberg
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3165 - Bentleigh East
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6008 - Subiaco
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4102 - Woolloongabba
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United Kingdom
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Cardiff
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United Kingdom
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Glasgow
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United Kingdom
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Guildford
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Plymouth
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United Kingdom
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Southampton
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United Kingdom
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Sutton
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United Kingdom
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Wirral
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bavarian Nordic
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01322490
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Trial related presentations / publications
Gulley JL, Borre M, Vogelzang NJ, Ng S, Agarwal N, Parker CC, Pook DW, Rathenborg P, Flaig TW, Carles J, Saad F, Shore ND, Chen L, Heery CR, Gerritsen WR, Priou F, Langkilde NC, Novikov A, Kantoff PW. Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2019 May 1;37(13):1051-1061. doi: 10.1200/JCO.18.02031. Epub 2019 Feb 28.
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Public notes
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Contacts
Principal investigator
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James L. Gulley, MD
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National Cancer Institute (NCI)
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/90/NCT01322490/SAP_000.pdf
Study protocol
https://cdn.clinicaltrials.gov/large-docs/90/NCT01322490/Prot_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01322490
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