Study Stopped
Poor accrual
Docetaxel and Prednisone With or Without Vaccine Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Randomized Phase II Trial of Docetaxel With or Without PSA-TRICOM Vaccine in Patients With Castrate-Resistant Metastatic Prostate Cancer
5 other identifiers
interventional
10
1 country
14
Brief Summary
This randomized phase II trial studies how well docetaxel and prednisone with or without vaccine therapy works in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vaccines made from an antigen may help the body build an effective immune response to kill tumor cells. It is not yet known whether docetaxel and prednisone are more effective with or without vaccine therapy in treating prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2010
Longer than P75 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2010
CompletedFirst Posted
Study publicly available on registry
June 16, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedResults Posted
Study results publicly available
July 23, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedSeptember 19, 2017
August 1, 2017
2.2 years
June 15, 2010
April 25, 2014
August 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall survival is defined as the time from randomization to death or the date of last known alive.
Assessed every 3 months for 2 years, and then every 6 months for 3 years
Study Arms (2)
Arm A (vaccine therapy and chemotherapy)
EXPERIMENTALPatients receive rilimogene-galvacirepvec SC on day 1 of course 1 and fowlpox-PSA-TRICOM vaccine SC on days 15, 29, 43, and 57 of course 1. Beginning on day 85 (day 1 of course 2), patients receive docetaxel IV over 1 hour on day 1 and prednisone PO BID on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Arm B (docetaxel, prednisone)
ACTIVE COMPARATORPatients receive docetaxel IV over 1 hour on day 1 and prednisone PO BID on days 1-21. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Correlative studies
Given PO
Given SC
Given SC
Eligibility Criteria
You may qualify if:
- Patient must have histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate)
- Patient must have metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies (computed tomography \[CT\] of abdomen/pelvis, bone scintigraphy)
- Patient must have castrate-resistant disease, defined as follows:
- Patient must have received standard of care androgen deprivation treatment (ADT) before trial entry (surgical castration versus gonadotropin-releasing hormone \[GnRH\] analogue or antagonist treatment); subjects receiving GnRH analogue or antagonist must continue this treatment throughout the time on this study
- Patient must have been treated previously with a nonsteroidal antiandrogen, with evidence of subsequent disease progression; subjects must be off use of anti-androgen for at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide or nilutamide) prior to randomization; subjects who demonstrate an anti-androgen withdrawal response, defined as a \>= 25% decline in PSA within 4-6 week of stopping a nonsteroidal antiandrogen are not eligible until the PSA rises above the nadir observed after antiandrogen withdrawal
- Patient must have castration levels of testosterone (\< 50 ng/dL) within 4 weeks prior to randomization
- Patient must have progressive disease while receiving ADT as defined by any one of the following as per the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria:
- PSA: at least two consecutive rises in serum PSA, obtained at a minimum of 1-week intervals, and each value \>= 2.0 ng/mL
- Measurable disease: \>= 50% increase in the sum of the cross products of all measurable lesions or the development of new measurable lesions by RECIST criteria version 1.1; the greatest diameter of a target lesion must be at least 1.0 cm by CT scan (1.5 cm in shortest axis for lymph nodes)
- Non-measurable (bone) disease: the appearance of two or more new areas of uptake on bone scan consistent with metastatic disease compared to previous imaging during castration therapy; the increased uptake of pre-existing lesions on bone scan will not be taken to constitute progression, and ambiguous results must be confirmed by other imaging modalities (e.g. X-ray, CT or magnetic resonance imaging \[MRI\])
- Patient must not have poor prognosis features suggested by the following required information:
- Presence of visceral (non-lymph node, non-bone) metastases
- Poor performance status (Eastern Cooperative Oncology Group \[ECOG\] performance status \[PS\] of 2 or greater)
- Alkaline phosphatase (IU/L) \> 2 x institutional upper limit of normal
- Lactate dehydrogenase (LDH) (U/L) \> 2 x institutional upper limit of normal
- +41 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Hematology and Oncology Associates
Chicago, Illinois, 60611, United States
Northwestern University
Chicago, Illinois, 60611, United States
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, 60035, United States
Presence Saint Mary's Hospital
Kankakee, Illinois, 60901, United States
NorthShore Hematology Oncology-Libertyville
Libertyville, Illinois, 60048, United States
Illinois Cancer Specialists-Niles
Niles, Illinois, 60714, United States
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, 60076, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG Statistical Office
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas McNeel
ECOG-ACRIN Cancer Research Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2010
First Posted
June 16, 2010
Study Start
August 1, 2010
Primary Completion
October 1, 2012
Study Completion
October 1, 2015
Last Updated
September 19, 2017
Results First Posted
July 23, 2014
Record last verified: 2017-08