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Selective Treatment According to Molecular Subtype of Prostate Cancer

NCT03696186 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2018-10-09

No results posted yet for this study

Summary

This is an open-label study that includes three substudies of random distribution. First, a sample of the primary tumor will be obtained and will be analyzed by an immunohistochemical technique to determine several markers. Depending on the expression of these markers, the patients will be characterize as group 1 (Luminal phenotype), group 2 (Neuroendocrine phenotype) or group 3 (Atypical phenotype) and a random assignment will be performed to standard or experimental treatment.

Conditions

  • Castration-resistant Prostate Cancer
  • Prostate Cancer Metastatic

Interventions

DRUG

Luminal type-1

Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily)

DRUG

Luminal type-2

Goserelin (3.75mg, once every 4 weeks)+Abiraterone (1000 mg, once daily)+Prednisone (5 mg, twice daily)

DRUG

Neuroendocrine type-1

Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily)

DRUG

Neuroendocrine type-2

Goserelin (3.75mg, once every 4 weeks)+Carboplatin (area under the curve 5 on day 1 every 3 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily)

DRUG

Atypical type-1

Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily)

DRUG

Atypical type-2

Goserelin (3.75mg, once every 4 weeks)+Abiraterone (1000 mg, once daily)+ targeted therapy according to next Generation Sequencing (NGS)+ Prednisone (5 mg, twice daily), or Goserelin (3.75mg, once every 4 weeks)+Abiraterone+ Prednisone (5 mg, twice daily) if no druggable gene mutation detected.

Sponsors & Collaborators

  • Tianjin Medical University Second Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2022-08-31
Completion
2023-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03696186 on ClinicalTrials.gov