Status:
COMPLETED
An Efficacy and Safety Study With Licroca Depot, a Controlled Release Product, Injected Into the Prostate
Lead Sponsor:
Lidds AB
Conditions:
Prostate Cancer
Eligibility:
MALE
45+ years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective was to evaluate efficacy of a single dose of Liproca Depot in patients with localized prostate cancer. Primary efficacy variable was the proportion of patients showing PSA nadir....
Detailed Description
Patients with localized prostate cancer were followed to progression or maximum 24 weeks after a single injection in one lobe of 2-8 mL ready-made paste (corresponding to 400-1600 mg 2-Hydroxyflutamid...
Eligibility Criteria
Inclusion
- Age ≥ 45years
- Histologically confirmed localized prostate cancer (T1-T2), predominantly in one side of the peripheral zone, verified by biopsy.
- PSA value \< 20 ng/ml within 6 weeks before enrolment.
- Gleason score ≤ 3+4 at diagnostic biopsy
- Adequate renal function: Creatinine \< 1.5 times upper limit of normal.
- Adequate hepatic function: ASAT, ALAT and ALP \< 1.5 times upper limit of normal.
- Negative dipstick for bacturia.
- Patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit.
Exclusion
- Previous or ongoing hormone therapy for prostate cancer.
- Ongoing or previous therapy (within3 month) of finasteride or dutasteride.
- Ongoing or previous invasive therapy for benign prostate hyperplasia (TURP, TUMT).
- Symptoms or signs of acute prostatitis.
- Symptoms or signs of ulceric proctitis
- Severe micturation symptoms (I-PSS \>17)
- Concomitant systemic treatment with corticosteroids, or immunomodulating agents.
- Known immunosuppressive disease (e.g. HIV, insulin dependent diabetes).
- Simultaneous participation in any other study involving not market authorized drugs or having participated in a study within the last 12 months prior to start of study treatment.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00913263
Start Date
June 1 2009
End Date
July 1 2011
Last Update
January 19 2015
Active Locations (2)
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1
Tampere University Hospital
Tampere, Finland, 33520
2
Tampere University Hospital
Tampere, Finland