Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000107729
Ethics application status
Not yet submitted
Date submitted
3/01/2013
Date registered
29/01/2013
Date last updated
29/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of intermittent versus continuous androgen deprivation therapy in Chinese patients with advanced prostate cancer: A prospective controlled Trial from China
Scientific title
Androgen Deprivation Therapy in Treating Patients With Prostate Cancer:A prospective controlled Trial from China
Secondary ID [1] 281718 0
Nil
Universal Trial Number (UTN)
U1111-1138-1814
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 288018 0
Condition category
Condition code
Cancer 288394 288394 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 286259 0
Treatment: Drugs
Comparator / control treatment
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 CAD arm patients continued with goserelin acetate and bicalutamide or underwent bilateral orchiectomy. The duration that participants in this arm continue with goserelin acetate and bicalutamide is for 3 years. Whether patients in the CAD arm will continue with goserelin acetate and bicalutamide or undergo bilateral orchiectomy depends on the will of patients. Because the operation is simple and the price is low.But it can make a difference on the psychology of patients.
Control group
Dose comparison

Outcomes
Primary outcome [1] 288567 0
Time To Progression (TTP)
Timepoint [1] 288567 0
Time To Progression (TTP) is difined as appearance of any new or worsening of existing bone metastases;increase in dimensions(by 25% or more)of any existing or appearance of any new extraskeletal metastases; ureteral obstruction either by primary tumor or pelvic nodal disease;lymphedema of lower extremities due to pelvic nodal involvement; recurrent vesical obstruction, bleeding(macroscopic hematuria) or pain due to growth of primary tumor
Secondary outcome [1] 300477 0
prostate cancer-specific survival
Timepoint [1] 300477 0
Prostate cancer-specific survival was defined as Death from prostate cancer. And the followup is 5 years post treatment
Secondary outcome [2] 300478 0
time to treatment failure
Timepoint [2] 300478 0
treatment failure is difined as death; adverse drug reaction requiring cessation of the randomized treatment; cancer progression;patient unwilling or unable to continue according to the protocol; patient refused the randomized treatment; administration of any additional systemic therapy or radiotherapy for prostate cancer, patient lost to followup; investigator’s decision in the patient’s best interest to stop the randomized therapy
Secondary outcome [3] 300479 0
quality of life
Timepoint [3] 300479 0
QoL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and prostate module for Quality of life annually for 5 years post treatment.

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
serially numbered, opaque, sealed envelopes.When researchers identified the conformity of subjects, the envelopes are opened and the subjects are assigned to the corresponding test group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
enter the website which is 'http://www.random.org/integers' to get the computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
2/01/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 4772 0
China
State/province [1] 4772 0
Shanghai

Funding & Sponsors
Funding source category [1] 286509 0
Hospital
Name [1] 286509 0
Changhai hospital' s" 1255"construction plan
Country [1] 286509 0
China
Primary sponsor type
Hospital
Name
Changhai Hospital, Second Military Medical University
Address
168 Changhai road yangpu district Shanghai (200433)
Country
China
Secondary sponsor category [1] 285297 0
None
Name [1] 285297 0
Address [1] 285297 0
Country [1] 285297 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288584 0
Changhai Hospital Ethics Committee
Ethics committee address [1] 288584 0
Changhai Hospital, Second Military Medical University,168 Changhai road yangpu district Shanghai 200433
Ethics committee country [1] 288584 0
China
Date submitted for ethics approval [1] 288584 0
15/12/2012
Approval date [1] 288584 0
Ethics approval number [1] 288584 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36794 0
Prof Gaoxu
Address 36794 0
Department of Urology, Changhai Hospital, Second Military Medical University 168 Changhai road yangpu district Shanghai(200433)
Country 36794 0
China
Phone 36794 0
+8602131161718
Fax 36794 0
Email 36794 0
gaoxu.changhai@gmail.com
Contact person for public queries
Name 36795 0
Dr LU Xin
Address 36795 0
Department of Urology, Changhai Hospital, Second Military Medical University 168 Changhai road yangpu district Shanghai(200433)
Country 36795 0
China
Phone 36795 0
+8602131161718
Fax 36795 0
Email 36795 0
luxin_smmu@163.com
Contact person for scientific queries
Name 36796 0
Dr Wang Hai-feng
Address 36796 0
Department of Urology, Changhai Hospital, Second Military Medical University 168 Changhai road yangpu district Shanghai(200433
Country 36796 0
China
Phone 36796 0
+8602131161718
Fax 36796 0
Email 36796 0
whfcmm91@gmail.com

No information has been provided regarding IPD availability


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No Supporting Document Provided


Results publications and other study-related documents

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