NCT01487902

Brief Summary

The purpose of this study is to assess the androgen deprivation therapy when patients with castration-resistant prostate cancer are treated with docetaxel-based chemotherapy.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-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

July 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Last Updated

December 8, 2011

Status Verified

December 1, 2011

Enrollment Period

3.3 years

First QC Date

December 5, 2011

Last Update Submit

December 7, 2011

Conditions

Castration-resistant Prostate Cancer

Keywords

Chemotherapy-naive

Outcome Measures

Primary Outcomes (1)

  • Time to PSA progression

    1 year

Secondary Outcomes (4)

  • Composite progression-free survival (PFS)

    1 year

  • Overall survival

    2 year

  • PSA decline

    12 weeks

  • PSA response to ADT retrial

    12 weeks

Study Arms (2)

ADT arm

EXPERIMENTAL

Concomitant androgen deprivation treatment

Drug: ADT

No ADT arm

ACTIVE COMPARATOR

No concomitant androgen deprivation treatment arm

Drug: No ADT

Interventions

ADTDRUG

Luprolide 11.25 mg long-acting depo (Lucrin Depot PDS inj®) every 12 weeks SC wit Docetaxel-prednisolone (TAX327 regimen)

ADT arm
No ADTDRUG

Docetaxel-prednisolone (TAX327 regimen) alone

No ADT arm

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Clinical or radiologic evidence of metastatic disease
  • Documented disease progression during hormone therapy (ADT with or without antiandrogen)
  • Cessation of ADT at least 4 weeks in non-orchiectomized patients
  • Adequate duration (at least 4 weeks for flutamide and 6 weeks for bicalutamide) of anti-androgen withdrawal (only for patients who showed a response or decline in PSA for more than 3 months)
  • KPS ≥ 60
  • No prior cyto-toxic chemotherapy (except estramustine) or radioisotopes
  • No prior radiotherapy 25% or more of the bone marrow
  • No peripheral neuropathy grade 2 or worse
  • Adequate organ and bone marrow function

You may not qualify if:

  • Other tumor type than adenocarcinoma
  • Presence or history of CNS metastasis
  • Other serious illness or medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

Related Links

Central Study Contacts

Jae-Lyun Lee, MD, PhD

CONTACT

82 2 3010 5977jaelyun@amc.seoul.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 8, 2011

Study Start

July 1, 2010

Primary Completion

October 1, 2013

Last Updated

December 8, 2011

Record last verified: 2011-12

Locations

KR(1)