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Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms. International, Multicenter Post-marketing Observational Study.


N/A
50 Years
N/A
Not Enrolling
Male
Advanced Prostate Cancer, Lower Urinary Tract Symptoms

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Trial Information

Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms. International, Multicenter Post-marketing Observational Study.


The remaining target is:

- to assess the intensity of LUTS in Polish and Ukrainian patients with locally advanced and
metastatic prostate cancer, previously untreated with hormonal therapy


Inclusion Criteria:



- Age > 50 years

- Locally advanced (T3-T4) and/or metastatic (N+/M+) hormone-sensitive prostate cancer,
confirmed by histological examination

- Presence of lower urinary tract symptoms (LUTS)-IPSS >0

- Treatment with Lucrin® Depot is the routine therapy in the patient. The decision as
to Lucrin® Depot choice will not be associated with patient's participation in the
study, but will result from the best medical knowledge and practice.

- Until inclusion into PMOS the patient has not been treated with GnRH analogue.

- The patient, before inclusion into the study, has not been treated by surgery
(radical prostatectomy).

Exclusion Criteria:

- Patients will not be included into the study if any contraindications to treatment
with Lucrin® Depot exist, or if there are other treatment options which, according to
the present medical knowledge, are potentially more beneficial for the patient.

- Physician or patient can stop treatment at any moment, if any indications or reasons
exist.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35.

Outcome Description:

The International Prostate Symptom Score (IPSS) is used to assess the severity of lower urinary tract symptoms (LUTS) and to monitor disease progression. The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining [rated as 0 (not at all) to 5 (almost always)], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more). The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.

Outcome Time Frame:

Baseline to 12 months

Safety Issue:

No

Principal Investigator

Jozef Haczynski, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Abbott Laboratories, Poland

Authority:

Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Study ID:

P10-612

NCT ID:

NCT01078545

Start Date:

September 2008

Completion Date:

November 2010

Related Keywords:

  • Advanced Prostate Cancer
  • Lower Urinary Tract Symptoms
  • Prostate cancer
  • Lower urinary tract symptoms
  • Hormonotherapy
  • LHRH analogue
  • Androgen deprivation therapy (ADT)
  • Prostatic Neoplasms

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