NCT03696186

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

4 years

First QC Date

October 3, 2018

Last Update Submit

October 4, 2018

Conditions

Castration-resistant Prostate CancerProstate Cancer Metastatic

Keywords

Metastatic Castration-resistant Prostate CancerCancer SubtypeChemotherapyTarget Therapy

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    OS was defined as the duration from the initiation of treatment to death of any cause

    Up to 40 months

Secondary Outcomes (3)

  • PSA-Progression free survival (pPFS)

    Up to 40 months

  • Radiographic progression free survival (rPFS)

    Up to 40 months

  • PSA response rate

    Up to 40 months

Study Arms (6)

Luminal type-1

ACTIVE COMPARATOR

Standard treatment

Drug: Luminal type-1

Luminal type-2

EXPERIMENTAL

Experimental treatment

Drug: Luminal type-2

Neuroendocrine type-1

ACTIVE COMPARATOR

Standard treatment

Drug: Neuroendocrine type-1

Neuroendocrine type-2

EXPERIMENTAL

Experimental treatment

Drug: Neuroendocrine type-2

Atypical type-1

ACTIVE COMPARATOR

Standard treatment

Drug: Atypical type-1

Atypical type-2

EXPERIMENTAL

Experimental treatment

Drug: Atypical type-2

Interventions

Luminal type-1DRUG

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

Luminal type-1
Luminal type-2DRUG

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

Luminal type-2
Neuroendocrine type-1DRUG

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

Neuroendocrine type-1
Neuroendocrine type-2DRUG

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)

Neuroendocrine type-2
Atypical type-1DRUG

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

Atypical type-1
Atypical type-2DRUG

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.

Atypical type-2

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants who have given consent form;
  • Patients with a confirmed diagnosis of mCRPC according to EAU 2018 guideline;
  • Serum testosterone must reach castration level: \<50 ng per deciliter;
  • Participants with life expectancy of at least 6 months based on the Investigator's clinical judgment.

You may not qualify if:

  • Participants who are allergic to contrast medium;
  • Patients were excluded if they planned to receive additional concurrent anticancer therapies;
  • Patients doesn't sign an informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical Unversity Second Hospital

Tianjin, 300211, China

RECRUITING

Central Study Contacts

Shimiao Zhu, MD,PhD

CONTACT

+86 137 5243 6539zhushimiao@tijmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2018

First Posted

October 4, 2018

Study Start

August 1, 2018

Primary Completion

August 1, 2022

Study Completion

August 1, 2023

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

CN(1)