Clinical trial NCT00913263: An Efficacy and Safety Study With Licroca Depot, a Controlled Release Product, Injected Into the Prostate
Official title: An Open, Single and Multiple Dose, Efficacy and Safety Proof of Principle Study of Liproca Depot, a Controlled Release Formulation of 2-hydroxyflutamide, Injected Into the Prostate in Patients With Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Prostate cancer
Lead sponsor: Lidds AB
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 24
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 24 Caucasian men, with a mean age at inclusion of 68.4 years, with localized prostate cancer were injected once with a ready made paste including 600 mg 2-hydroxyflutamide (Liproca Depot) into the site of the prostate where the tumour was localized. The patient was monitored for prostate-specific antigen (PSA) for maximum 6 months or to progression within this time period. The primary endpoint showed interesting results with high success rate (83%), i.e. proportion of patients (Responders) that reached plasma 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). Progression was defined as an increase in PSA by \> 25% over baseline or on-treatment nadir.Among the 24 patients the primary endpoint, plasma PSA nadir, was reached by 20 patients (Responders). Efficacy was measured primarily as PSA nadir, and secondly as time to PSA nadir and prostate volume change. Safety was monitored throughout the whole study period.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 45years
2. Histologically confirmed localized prostate cancer (T1-T2), predominantly in one side of the peripheral zone, verified by biopsy.
3. PSA value \< 20 ng/ml within 6 weeks before enrolment.
4. Gleason score ≤ 3+4 at diagnostic biopsy
5. Adequate renal function: Creatinine \< 1.5 times upper limit of normal.
6. Adequate hepatic function: ASAT, ALAT and ALP \< 1.5 times upper limit of normal.
7. Negative dipstick for bacturia.
8. Patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit.

Exclusion Criteria:

1. Previous or ongoing hormone therapy for prostate cancer.
2. Ongoing or previous therapy (within3 month) of finasteride or dutasteride.
3. Ongoing or previous invasive therapy for benign prostate hyperplasia (TURP, TUMT).
4. Symptoms or signs of acute prostatitis.
5. Symptoms or signs of ulceric proctitis
6. Severe micturation symptoms (I-PSS \>17)
7. Concomitant systemic treatment with corticosteroids, or immunomodulating agents.
8. Known immunosuppressive disease (e.g. HIV, insulin dependent diabetes).
9. 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.

Primary outcomes:
measure: Proportion of Patients Showing PSA Nadir
timeFrame: Measured every 4th week until progression or maximum 6 months.
Secondary outcomes:
measure: Number of Patients Reporting Adverse Events Caused by the Study Treatment
timeFrame: Measured every 4th week till progression or maximum 6 months
measure: Percent Change in Prostate Volume From Baseline to Nadir.
timeFrame: Measured every 4th week until progression or maximum 6 months.
measure: Time to PSA Nadir
timeFrame: Measured every 4th week until progression or maximum 6 moths.
measure: Percent Change in Prostate Volume From Baseline to Final Visit
timeFrame: Measured every 4th week until progresion or maximum 6 months.
measure: Number of Days to Prostate Volume Nadir.
timeFrame: Measured every 4th week until progression or maximum 6 months.
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Teuvo Tammela, Professor
role: PRINCIPAL_INVESTIGATOR
References: