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

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: 2-hydroxyflutamide (2-HOF) [Liproca Depot]; Drug: 2-Hydroxyflutamide

• Registration Number: NCT00913263
• Lead Sponsor: Lidds AB

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-03
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Primary Completion: 2011-05
• Study Completion: 2011-07
• Status Verified: 2013-04
• Results First Submitted: 2013-04-22
• Results First Submitted QC: 2015-01-15
• Last Update Submitted: 2015-01-15
• Results First Posted: 2015-01-19
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2-Hydroxyflutamide	2-Hydroxyflutamide	Single injection of 2-Hydroxyflutamide (2-8mL ready-made paste)in one prostate lobe
2-Hydroxyflutamide	2-hydroxyflutamide (2-HOF) [Liproca Depot]	Single injection of 2-Hydroxyflutamide (2-8mL ready-made paste)in one prostate lobe

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Showing PSA Nadir	Measured every 4th week until progression or maximum 6 months.	Plasma PSA nadir is the lowest PSA reading achieved after any treatment for prostate cancer. The patients were observed once every 4th week during the study period.

Secondary Outcome Measures

Name	Time	Method
Time to PSA Nadir	Measured every 4th week until progression or maximum 6 moths.	Time frame was from baseline to day of PSA nadir.
Number of Days to Prostate Volume Nadir.	Measured every 4th week until progression or maximum 6 months.	Number of Days from day of injection to prostate volume nadir.
Number of Patients Reporting Adverse Events Caused by the Study Treatment	Measured every 4th week till progression or maximum 6 months	* Adverse events caused by the study treatment; * Abnormal, clinically relevant, laboratory parameters; * Voiding symptoms; * Vital Signs; * Quality of Life
Percent Change in Prostate Volume From Baseline to Nadir.	Measured every 4th week until progression or maximum 6 months.	Prostate volume was measured at each visit to capture nadir and compared to baseline for all patients. Decrease in prostate volume is reported as percent change from baseline.
Percent Change in Prostate Volume From Baseline to Final Visit	Measured every 4th week until progresion or maximum 6 months.	Prostate volume was captured at each visit and percent change from baseline to final visit was measured. Final visit was either day of progression or after 6 months. Prostate volume decrease is reported in percent change from baseline

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland