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.
- Conditions
- ocally advanced or metastatic prostate cancer with Lower Urinary Tract Symptoms (LUTS)Locally advanced or metastatic prostate cancer with Lower Urinary Tract Symptoms (LUTS)Cancer - ProstateRenal and Urogenital - Other renal and urogenital disorders
- Registration Number
- ACTRN12610000558022
- Lead Sponsor
- Ipsen Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Male
- Target Recruitment
- 70
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).
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the percentage of patients suffering from prostate cancer with moderate to severe LUTS (score International Prostate Symptom Score (IPSS) >7) with at-least 3 points reduction of IPSS score at the end of study week 48 (W48)[48 weeks after baseline.]
- Secondary Outcome Measures
Name Time Method