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Clinical Trials in South Korea / NCT03456843
Active, not recruiting Phase 2

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

NCT03456843 · tracked via the Priya Life Science South Korea tracker
Sponsor
Yale University
Phase
Phase 2
Started
2018-03-20
Last updated
2026-07-24

Condition(s) studied

Stage IV Prostate Adenocarcinoma AJCC v7

Investigational drug(s) / intervention(s)

Antiandrogen TherapyDocetaxel →Laboratory Biomarker AnalysisQuality-of-Life AssessmentQuestionnaire AdministrationRadical Prostatectomy

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.

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.

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Radical Prostatectomy: Undergo cytoreductive radical prostatectomy

Study summary

This is a phase 2.5 international, multi-institution, randomized clinical trial to evaluate the potential therapeutic effect of CRP combined with the BST in men with mPCa prospectively. Such hybrid design permits the inclusion of the patients who have accrued to the phase 2 investigation to phase 3 trial, thereby decreasing the number of patients needed overall (5-7). In the initial phase 2 study, we plan to accrue 190 patients.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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), M1b (bone metastasis), or M1c (solid organ 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 (i.e prostate radiation, cryotherapy, etc.) * Give informed consent * Prostate deemed resectable by surgeon * Plans to start or has already started ADT no longer than 6 months prior to consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Hemoglobin (HgB) \>= 9 g/dL compatible for surgery * Platelets \> 80,000/mcL compatible for surgery * Aspartate aminotransferase (AST) =\< 2x upper limit of normal (ULN) compatible for surgery * Alanine aminotransferase (ALT) =\< 2x upper limit of normal (ULN) compatible for surgery Exclusion Criteria: * Refuses to give informed consent * Deemed to have unresectable disease by surgeon * Received ADT for more than 6 months prior to consent * Life expectancy of less than 6 months prior to consent * Active spinal cord compression * Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to consent * Previous local therapy for prostate cancer * Patients who have chemotherapy or radiotherapy for non-prostate cancer related treatment within 3 weeks prior to consent

Primary outcome measure(s)

  • Failure-free survival (FFS) — At 2 years
    Failure is defined as any one of the following events: PSA progression, clinical progression, radiographic progression, or death. The % of men who fail within 2 years of randomization will be compare between the two groups using a one-sided log-rank test.

Trial sites (16)

FacilityCityRegionStatus
City of Hope Duarte California
University of California, Irvine Irvine California
University of Southern California Los Angeles California
Yale University New Haven Connecticut
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
University of Pennsylvania Philadelphia Pennsylvania
Swedish Medical Services Seattle Washington
Epworth Healthcare East Melbourne Australia
Chinese University of Hong Kong Hong Kong China
Kindai University Ōsaka-sayama Osaka
Akita University Akita Japan
Juntendo University Tokyo Japan
National Cancer Center Goyang-si South Korea
Seoul National University Bundang Hospital Gyeonggi-do South Korea
Samsung Medical Center Seoul South Korea
National Taiwan University Hospital Taipei Taiwan

More Yale University trials in South Korea

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03456843 on ClinicalTrials.gov ↗ ← All trials in South Korea