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Clinical Trials/ACTRN12613000107729
ACTRN12613000107729
Active, not recruiting
Phase 4

Androgen Deprivation Therapy in Treating Patients With Prostate Cancer:A prospective controlled Trial from China

Changhai Hospital, Second Military Medical University0 sites100 target enrollmentJanuary 29, 2013

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
prostate cancer
Sponsor
Changhai Hospital, Second Military Medical University
Enrollment
100
Status
Active, not recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 29, 2013
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
Changhai Hospital, Second Military Medical University

Eligibility Criteria

Inclusion Criteria

  • .Inclusion Criteria (run\-in period):
  • 1\)Histologically confirmed adenocarcinoma of the prostate
  • 2\)T1\-T4, metastatic (M1\) prostate cancer, T1\-T4, non\-metastatic (M0\), N\+ prostate cancer
  • .Inclusion criteria to the randomised period:
  • All patients recruited received the LHRHa goserelin acetate(Zoladex 3\.6mg) subcutaneously every 28 days and bicalutamide(Casodex 50mg) orally once daily for 8 months(run in) before randomization. Patients in whom PSA decreased to less than 4\.0ng/ml were randomized to IAD or CAD.

Exclusion Criteria

  • .Exclusion Criteria (run\-in period):
  • Any previous or concurrent treatment of prostate cancer, except TURP, 5\-alpha reductase inhibitor, radical prostatectomy or radiotherapy Any medication/treatment affecting sex hormone status
  • .Exclusion Criteria:
  • Patients in whom prostate specific antigen decreased to no less than 4ng/ml were excluded

Outcomes

Primary Outcomes

Not specified

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