An Efficacy and Safety Study With Licroca Depot, a Controlled Release Product, Injected Into the Prostate

NCT ID: NCT00913263

Last Updated: 2015-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-07-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2-Hydroxyflutamide

Single injection of 2-Hydroxyflutamide (2-8mL ready-made paste)in one prostate lobe

Group Type: EXPERIMENTAL

2-hydroxyflutamide (2-HOF) [Liproca Depot]

Intervention Type: DRUG

Ready made paste including 600 mg 2-HOF for injection as a single dose

2-Hydroxyflutamide

Intervention Type: DRUG

The Product consists of two sterile components, one aqueous liquid and a dry powder, containing the active drug 2-Hydroxyflutamide (2-HOF. The two components were mixed under aceptic conditions to a paste prior to administration.

Interventions

2-hydroxyflutamide (2-HOF) [Liproca Depot]

Ready made paste including 600 mg 2-HOF for injection as a single dose

Intervention Type: DRUG

2-Hydroxyflutamide

The Product consists of two sterile components, one aqueous liquid and a dry powder, containing the active drug 2-Hydroxyflutamide (2-HOF. The two components were mixed under aceptic conditions to a paste prior to administration.

Intervention Type: DRUG

Other Intervention Names

Liproca Depot; Liproca Depot

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Lidds AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teuvo Tammela, Professor

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

Tampere University Hospital

Tampere, , Finland

Tampere University Hospital

Tampere, , Finland

Countries

Finland

Other Identifiers

2009-010079-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LPC-002

Identifier Type: -

Identifier Source: org_study_id