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Trial registered on ANZCTR


Registration number
ACTRN12618000664246
Ethics application status
Approved
Date submitted
12/03/2018
Date registered
24/04/2018
Date last updated
24/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Studying the need of medical treatment together with removal of the testes surgically to treat men with late cancer of prostate.
Scientific title
Is Combined Androgen Blockade by Surgical Castration and Flutamide Necessary as an Initial Therapy for Patients with Advanced Prostate Cancer? A randomized clinical trial.
Secondary ID [1] 294305 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 307393 0
Condition category
Condition code
Cancer 306105 306105 0 0
Prostate
Surgery 306549 306549 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with advanced prostate cancer were randomized into two groups after being subjected to surgical castration by bilateral simple orchidectomy . The duration of surgery was about 30 minutes. Group I was followed up for disease progression after orchidectomy alone.Group II patients also had underwent bilateral simple orchidectomy but additionally they were given oral flutamide 250 mg tablets three times daily after meals for up to two years and were followed up. Bilateral simple Orchidectomy for both groups was done by scrotal approach under spinal anesthesia . The patients were asked to return the drug tablet to ensure adherence to the intervention.The follow up period was up to two years following orchidectomy for both groups.
Intervention code [1] 300606 0
Treatment: Other
Comparator / control treatment
Group I patients who underwent orchidectomy only was considered as the comparator reference group.
Control group
Active

Outcomes
Primary outcome [1] 305136 0
Percent change in values of PSA . Levels of PSA were assessed by serum assay for all patients.
Timepoint [1] 305136 0
One month , two month and three months following orchidectomy ( primary endpoint ) . The serum PSA was assessed at the end of first month , second month and third month following orchidectomy to detect the maximum percent change in serum PSA.
Primary outcome [2] 305505 0
Percent change in levels of serum testosterone were assessed by serum assay.
Timepoint [2] 305505 0
One month , two month and three months following orchidectomy ( primary endpoint ) . The serum testosterone was assessed at the end of first month , second month and third month following orchidectomy to detect the maximum percent change in serum testosterone.
Secondary outcome [1] 344293 0
Percent change in serum PSA at the end of second year following orchidectomy
Timepoint [1] 344293 0
This outcome will be assessed a single time at the end of the second year following orchidectomy .
Secondary outcome [2] 345512 0
This is a composite outcome by checking for disease spread to distant organs despite initiation of therapy.This was measured by detection of new metastasis in bone , liver or other organs by doing Ct scan of abdomen and bone radiology,
Timepoint [2] 345512 0
This outcome was assessed a single time at the end of the second year following orchidectomy for both groups.

Eligibility
Key inclusion criteria
Patients with advanced prostate cancer
Minimum age
55 Years
Maximum age
75 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
patients with local disease or severe co-morbidities .

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by giving patients numbers at time of recruitment , then patients with odd numbers were allocated to group I and those with even numbers to group II.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analysis of variance ( ANOVA ) was used to analyze the differences among groups mean and percentage.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9675 0
Iraq
State/province [1] 9675 0
Basrah

Funding & Sponsors
Funding source category [1] 298951 0
Hospital
Name [1] 298951 0
Basrah General Hospital
Address [1] 298951 0
Iraq- Bsarah - Hayy Al Kafaat , St. no. 12 near Saad Sq.
Country [1] 298951 0
Iraq
Funding source category [2] 298952 0
University
Name [2] 298952 0
Basrah University
Address [2] 298952 0
Iraq - Basrah - al -Bradehia St. no 10
PO. Box 953
Country [2] 298952 0
Iraq
Primary sponsor type
University
Name
Basrah university
Address
Iraq - Basrah al Bradehia St. no 10
PO. Box 953
Country
Iraq
Secondary sponsor category [1] 298164 0
None
Name [1] 298164 0
None
Address [1] 298164 0
None
Country [1] 298164 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299888 0
Basrah college of medicine
Ethics committee address [1] 299888 0
Iraq - Basrah al Bradheia
Ethics committee country [1] 299888 0
Iraq
Date submitted for ethics approval [1] 299888 0
02/01/2012
Approval date [1] 299888 0
25/02/2012
Ethics approval number [1] 299888 0
2343

Summary
Brief summary
Prostate cancer is still a common disease worldwide. It can lead to death. Many ways to for treating this disease do exist. This study aimed to compare two ways of treatment of this disease especially when it's advanced or late. Men aged 55 to 75 years were included in this study. All of them were having prostate cancer at a late stage. All patients had underwent surgical removal of both testes. However, some of the patients in the study were given a specific drug for Prostate cancer as additional treatment way. Both groups of men were followed for their response to the surgery alone or to the surgery with medicine to discover how they differ in their improvement state. The main goal was to know whether it is useful to give the patients medical treatment beside the surgery to control their disease. The men in the study were real patients and they were offered the necessary treatment after taking their consent. No major serious bad events were expected to occur for them as a result of these treatments apart from the effect of their cancer. About 60 men were included in the study which was done in Iraq at Basrah Teaching Hospital in Basrah city. The study started in 2012 and continued for about 5 years. However, for each individual patient the period of involvement in the study was about two years.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81874 0
A/Prof Firas Shakir Attar
Address 81874 0
Iraq -Basrah 1135 - 42001 Ashar. Basrah College of medicine .
Country 81874 0
Iraq
Phone 81874 0
+9647801642247
Fax 81874 0
Email 81874 0
firasshakir97@yahoo.com
Contact person for public queries
Name 81875 0
A/Prof Firas Shakir Attar
Address 81875 0
Iraq -Basrah 1135 - 42001 Ashar. Basrah college of medicine .
Country 81875 0
Iraq
Phone 81875 0
+9647801642247
Fax 81875 0
Email 81875 0
firasshakir97@yahoo.com
Contact person for scientific queries
Name 81876 0
A/Prof Firas Shakir Attar
Address 81876 0
Iraq -Basrah 1135 - 42001 Ashar. Basrah college of medicine .
Country 81876 0
Iraq
Phone 81876 0
+9647801642247
Fax 81876 0
Email 81876 0
firasshakir97@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary