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The effect of intermittent versus continuous androgen deprivation therapy in Chinese patients with advanced prostate cancer: A prospective controlled Trial from China

Phase 4
Active, not recruiting
Conditions
prostate cancer
Cancer - Prostate
Registration Number
ACTRN12613000107729
Lead Sponsor
Changhai Hospital, Second Military Medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Active, not recruiting
Sex
Male
Target Recruitment
100
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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