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Type(s) of Cancer
Prostate
Study Phase
Phase 3
Study Completion Date
October 2018
NCT00430183Uploaded 02-07-2023
Access via NCI by Request
PDS UID: nci-data-506
A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer
Provider Information
Provider Data DescriptionDataset NCT00430183-D1-Dataset.csv (baseline) is one of 2 datasets associated with PubMed ID 32706639. This dataset contains information that is presented in the manuscript excluding the toxicity data.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and leuprolide or goserelin before surgery is more effective than surgery alone in treating patients with prostate cancer. PURPOSE: This randomized phase III trial is studying docetaxel and leuprolide or goserelin to see how well they work when given before surgery compared with surgery alone in treating patients with high-risk localized prostate cancer.
ConditionsProstate Cancer
Intervention TypeDrug: docetaxel
Drug: LHRH agonist
Procedure: surgery
Drug(s)Drug: docetaxel
Drug: LHRH agonist
Total Enrolled788
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A: docetaxel + LHRH agonist + surgical intervention - Experimental
Arm B: surgical intervention - Other
Secondary IDU10CA031946
PubMed (PMID)32706639
Collaborator(s)National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Southwest Oncology Group
Region(s)United States
Canada
Age Range18 Years and older (Adult, Older Adult)
Files: NCT00430183-D1
Data DictionaryNCT00430183-D1-Data-Dictionary_2.pdf
DATANCT00430183-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00430183-D2
Data DictionaryNCT00430183-D2-Data-Dictionary_2.pdf
DATANCT00430183-D2-Dataset_2.csv
OTHERREADME.pdf
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