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Studying the need of medical treatment together with removal of the testes surgically to treat men with late cancer of prostate.

Is Combined Androgen Blockade by Surgical Castration and Flutamide Necessary as an Initial Therapy for Patients with Advanced Prostate Cancer? A randomized clinical trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000664246
Enrollment
51
Registered
2018-04-24
Start date
2012-05-20
Completion date
2015-09-30
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 Orchi

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.

Sponsors

Basrah university
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
Male
Age
55 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Patients with advanced prostate cancer

Exclusion criteria

patients with local disease or severe co-morbidities .

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026