Clinical trial NCT03070886: Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery
Official title: Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or Without Adjuvant Docetaxel
Conditions: Stage I Prostate Adenocarcinoma AJCC v7
Stage II Prostate Adenocarcinoma AJCC v7
Stage III Prostate Adenocarcinoma AJCC v7
Summary: This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, 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. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.
Interventions:
description: Given orally (PO)
name: Bicalutamide
other_name: Casodex
Cassotide
Cosudex
ICI 176,334
ICI 176334
Utamide
type: Drug
description: Given IM
name: Degarelix
other_name: ASP 3550
ASP-3550
ASP3550
FE 200486
FE-200486
FE200486
Firmagon
type: Drug
description: Given IV
name: Docetaxel
other_name: Docecad
RP 56976
RP-56976
RP56976
Taxotere
Taxotere Injection Concentrate
type: Drug
description: Undergo external beam radiation therapy
name: External Beam Radiation Therapy
other_name: Definitive Radiation Therapy
EBRT
External Beam RT
External Beam Radiation
External Beam Radiotherapy
External Beam Radiotherapy (conventional)
External Radiation Therapy
Radiation, External Beam
Teleradiotherapy
Teletherapy
Teletherapy Radiation
external radiation
external-beam radiation
type: Radiation
description: Given PO
name: Flutamide
other_name: 4'-Nitro-3'-trifluoromethylisobutyranilide
Apimid
Cebatrol
Chimax
Cytomid
Drogenil
Euflex
Eulexine
FLUT
Flucinom
Flucinome
Flugerel
Fluken
Flulem
Fluta-Gry
Flutabene
Flutacan
Flutamex
Flutamin
Flutan
Flutaplex
Fugerel
Grisetin
Niftolide
Oncosal
Profamid
Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-
Prostacur
Prostadirex
Prostica
Prostogenat
Sch 13521
Tafenil
Tecnoflut
Testotard
type: Drug
description: Given IM
name: Goserelin
other_name: ICI-118630
type: Drug
description: Given IM
name: Goserelin Acetate
other_name: ZDX
Zoladex
type: Drug
description: Correlative studies
name: Laboratory Biomarker Analysis
type: Other
description: Given intramuscularly (IM)
name: Leuprolide
other_name: Leuprorelin
type: Drug
description: Given IM
name: Leuprolide Acetate
other_name: A 43818
A-43818
A43818
Abbott 43818
Abbott-43818
Carcinil
Depo-Eligard
Eligard
Enanton
Enantone
Enantone-Gyn
Fensolvi
Ginecrin
LEUP
Leuplin
Leuprorelin Acetate
Lucrin
Lucrin Depot
Luprodex Depot
Lupron
Lupron Depot
Lupron Depot-3 Month
Lupron Depot-4 Month
Lupron Depot-Ped
Lutrate
Procren
Procrin
Prostap
TAP 144
TAP-144
TAP144
Trenantone
Uno-Enantone
Viadur
type: Drug
description: Drug
name: Nilutamide
other_name: Anandron
Nilandron
RU-23908
type: Drug
Study arms:
design_group_description: Patients receive androgen deprivation therapy comprising leuprolide acetate, goserelin acetate, degarelix, bicalutamide, flutamide, or nilutamide for 6 months. Beginning 8 weeks after the start of androgen deprivation therapy, patients receive EBRT for 7.5 weeks.
design_group_title: Arm I (androgen deprivation therapy, EBRT)
design_group_type: Active Comparator
design_group_description: Patients receive androgen deprivation therapy and EBRT as in Arm I. Within 4-6 weeks after completion of radiation therapy, patients receive docetaxel IV over 1 hour on day 1 of every 21 days for 6 cycless in the absence of disease progression or unexpected toxicity.
design_group_title: Arm II (androgen deprivation therapy, EBRT, docetaxel)
design_group_type: Experimental
Sponsor: NRG Oncology
Collaborators: National Cancer Institute
Drug name mappings:
name: 醋酸地加瑞克
lang: CN
name: Degarelix Acetate
lang: EN
name: デガレリクス酢酸塩
lang: JP
name: 比卡鲁胺
lang: CN
name: Bicalutamide
lang: EN
name: ビカルタミド
lang: JP
name: 多西他赛
lang: CN
name: Docetaxel
lang: EN
name: ドセタキセル
lang: JP
name: 醋酸亮丙瑞林
lang: CN
name: Leuprolide Acetate
lang: EN
name: リュープロレリン酢酸塩
lang: JP
name: 氟他胺
lang: CN
name: Flutamide
lang: EN
name: フルタミド
lang: JP
name: 醋酸戈舍瑞林
lang: CN
name: Goserelin Acetate
lang: EN
name: ゴセレリン酢酸塩
lang: JP
name: 尼鲁米特
lang: CN
name: Nilutamide
lang: EN