None listed
Conditions
Brief summary
Prostate cancer (PCa) is one of the most common malignant tumors in older men, endocrine therapy as the standard treatment of advanced prostate cancer, has become an important part of the clinical work of PCa. In 2 to 3 years, almost all patients with continuous androgen deprivation(CAD) progress to androgen-independent prostate cancer. At the same time, CAD treatment has also been associated with significant side effects, leads to the decline in the quality of life of patients and increase costs. In order to delay the emergence of androgen-independent prostate cancer, prolong the survival time of the patients, and improve quality of life, intermittent androgen deprivation(IAD) may be the Effective treatment. IAD perform well in animal models, but Prostate cancer is with a high degree of ethnic specificity (black and white incidence was significantly higher than the yellow race), Endocrine therapy may also have a similar heterogeneity. In other words, the foreign study results might does not apply to Chinese prostate cancer patient. Since there is no such prospective clinical study in China, we conducted the RCT in order to develop the Chinese intermittent hormonal therapy for prostate cancer patients.
Interventions
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 intermittent androgen deprivation(IAD) or continuous androgen deprivation(CAD) at a 1:1 ratio. In the IAD arm all the medicine was withheld after randomization and was resumed for at least 8 months whenever PSA increased more tha
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 intermittent androgen deprivation(IAD) or continuous androgen deprivation(CAD) at a 1:1 ratio. In the IAD arm all the medicine was withheld after randomization and was resumed for at least 8 months whenever PSA increased more than 20.0ng /ml with metastatic(M1) prostate cancer[10.0ng/ml with non-metastatic(M0)] and withheld again by the same criteria as for randomization.The overall duration of the intervention is 3 years. And treatment required in the IAD arm is the same as that received prior to randomisation.
Sponsors
Changhai Hospital, Second Military Medical University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
40 Years to 80 Years
Healthy volunteers
No
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
Outcome results
None listed