Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

March 20, 2018

Primary Completion Date

March 31, 2027

Study Completion Date

March 31, 2027

Conditions
Stage IV Prostate Adenocarcinoma AJCC v7
Interventions
DRUG

Antiandrogen Therapy

To demonstrate at least 30% improvement in FFS at 2 years after randomization with the power of 90% and error of 5% on a one-sided exponential MLE test.

DRUG

Docetaxel

To demonstrate at least 30% improvement in FFS at 2 years after randomization with the power of 90% and error of 5% on a one-sided exponential MLE test.

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Radical Prostatectomy

Undergo cytoreductive radical prostatectomy

Trial Locations (17)

9084

TERMINATED

Epworth Healthcare, East Melbourne

19104

TERMINATED

Unniversity of Pennsylvania, Philadelphia

90033

RECRUITING

University of Southern California, Los Angeles

91010

RECRUITING

City of Hope, Duarte

92697

TERMINATED

University of California, Irvine, Irvine

98104

RECRUITING

Swedish Medical Services, Seattle

06519

RECRUITING

Yale University, New Haven

08903

RECRUITING

Rutgers Cancer Institute of New Jersey, New Brunswick

Unknown

RECRUITING

Chinese University of Hong Kong, Hong Kong

RECRUITING

Akita University, Akita

RECRUITING

Juntendo University, Tokyo

RECRUITING

National Cancer Center, Goyang-si

RECRUITING

Seoul National University Bundang Hospital, Gyeonggi-do

RECRUITING

Samsung Medical Center, Seoul

RECRUITING

National Taiwan University Hospital, Taipei

606-8501

WITHDRAWN

Kyoto University, Sako

589-8511

RECRUITING

Kindai University, Ōsaka-sayama

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Yale University

OTHER