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.
Investigators
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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