A prospective non-interventional study to evaluate the effect of Triptorelin Embonate (Diphereline (Trademark TM) 11.25mg) on lower urinary tract symptoms (LUTS) in Australian prostate cancer patients.

A prospective non-interventional study to evaluate the effect of Triptorelin Embonate (Diphereline (TM) 11.25mg) on lower urinary tract symptoms (LUTS) in Australian prostate cancer patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12610000558022

Enrollment

Registered

2010-07-12

Start date

2011-03-08

Completion date

2013-06-12

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

This study will collect information from routine clinical care with the intention of evaluating the effect of Diphereline on the symptoms that are present in many men with prostate cancer, such as difficulty in postponing urination, how often they have a weak urinary stream and/or the need to push or strain to begin urination. These symptoms are referred to as lower urinary tract symptoms (LUTS).

Interventions

This is an observational study investigating the effect of Triptorelin Embonate (Diphereline (TM) 11.25mg) on lower urinary tract symptoms (LUTS) in Australian prostate cancer patients. The study participation duration for each patient will be 48 weeks. Each subject will receive 4 intramuscular injections of the Triptorelin Embonate (Diphereline (TM) 11.25mg) every 12 weeks at baseline, weeks 12, 24 and 36. This study is collecting data about the subject’s normal treatment with Triptorelin Embonate (Diphereline (TM)) looking at the effect of this drug on lower urinary tract symptoms (LUTS) in Australian prostate cancer patients. The subject will continue to be treated for prostate cancer according to the best medical practice in Australia. The subject's medical care will not change in anyway as a result of the study and no additional tests or examinations are needed. The only difference will be that subject’s medical details will be recorded not only as it is routinely done in their clinic notes, but also anonymously in an electronic database.

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1.The patient is suffering from locally-advanced (at least Tumour 3 stage) or metastatic prostate cancer scheduled to receive Diphereline (TM) 11.25mg. 2.The patient is presenting with moderate to severe LUTS ((lower urinary tract symptoms) IPSS score >7).

Exclusion criteria

1.The patient has a risk of serious complication in the case of tumour flare (vertbral metastases threatening spinal cord compression or significant obstructive uropathy). 2.History of surgical castration. 3.History of urethral stricture. 4.Life expectancy of less than 12 months. 5.Has undergone surgery for the treatment of lower urinary tract symptoms(LUTS). 6.Therapy with a Luteinizing hormone-releasing hormone (LHRH) analogue in the last 6 months. 7. Has received alpha receptor blockers in the last two weeks prior to the start of the study.

Outcome results