UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of local therapy for metastatic prostate cancer
Title of the study (Brief title)	Impact of local therapy for metastatic prostate cancer
Region	Japan

Condition
Condition	metastatic prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of local therapy for metastatic prostate cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Progression-free survival PSA response Objective response

Base
Study type	Interventional

Study design
Basic design	expanded access
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Standard therapy + Operation or radiotherapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male
Key inclusion criteria	Histologically proven adenocarcinoma of the prostate Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation Clinical stage M1a (distant lymph node positive), or M1b (bone metastasis) If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET [positron emission tomography], bone scan and MRI, modality at the discretion of the treating physician) No previous local therapy for prostate cancer Give informed consent Prostate deemed resectable by surgeon Started antiandrogen therapy (ADT) no longer than 6 months prior to randomization Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Hemoglobin (HgB) >= 9 g/dL compatible for surgery Platelets > 80,000 compatible for surgery Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =< 2x upper limit of normal (ULN) compatible for surgery
Key exclusion criteria	Refuses to give informed consent Deemed to have unresectable disease by surgeon Received ADT for more than 6 months prior to randomization Life expectancy of less than 6 months prior to randomization Known spinal cord compression M1c disease (solid organ metastasis) Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to randomization Previous local therapy for prostate cancer Previous chemotherapy for prostate cancer Patients who have chemotherapy, radiotherapy or oral antifungal agents (ketoconazole, itraconazole, fluconazole) within 3 weeks prior to entering the study or those who have not recovered (e.g. back to baseline or grade 1) from adverse events due to agents administered more than 3 weeks earlier Any drug interactions that are deemed to be medically significant would require a washout of 5-half-lives of the interaction agent before enrollment can occur
Target sample size	50

Research contact person
Name of lead principal investigator	Shingo Hatakeyama
Organization	Hirosaki University School of Medicine
Division name	Urology
Address	5 zaifu-chou, Hirosaki, Japan
TEL	0172395091
Email	shingoh@hirosaki-u.ac.jp

Public contact
Name of contact person	Shingo Hatakeyama
Organization	Hirosaki University School of Medicine
Division name	Urology
Address	5 zaifu-chou, Hirosaki, Japan
TEL	0172395091
Homepage URL
Email	shingoh@hirosaki-u.ac.jp

Sponsor
Institute	Hirosaki University School of Medicine
Institute
Department

Funding Source
Organization	Japan society for the promotion of science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 11 Month 01 Day
Anticipated trial start date	2019 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 11 Month 07 Day
Last modified on	2018 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039684