Back to resultsAn Efficacy and Safety Study With Licroca Depot, a Controlled Release Product, Injected Into the Prostate (2-HOF)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
Finland
Study Type
Interventional
Intervention
2-hydroxyflutamide (2-HOF) [Liproca Depot]
2-Hydroxyflutamide
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Tampere University Hospital
- Tampere University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
2-Hydroxyflutamide
Arm Description
Single injection of 2-Hydroxyflutamide (2-8mL ready-made paste)in one prostate lobe
Outcomes
Primary Outcome Measures
Proportion of Patients Showing PSA Nadir
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
Number of Patients Reporting Adverse Events Caused by the Study Treatment
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.
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.
Time to PSA Nadir
Time frame was from baseline to day of PSA nadir.
Percent Change in Prostate Volume From Baseline to Final Visit
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
Number of Days to Prostate Volume Nadir.
Number of Days from day of injection to prostate volume nadir.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00913263
Brief Title
An Efficacy and Safety Study With Licroca Depot, a Controlled Release Product, Injected Into the Prostate
Acronym
2-HOF
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
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lidds AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2-Hydroxyflutamide
Arm Type
Experimental
Arm Description
Single injection of 2-Hydroxyflutamide (2-8mL ready-made paste)in one prostate lobe
Intervention Type
Drug
Intervention Name(s)
2-hydroxyflutamide (2-HOF) [Liproca Depot]
Other Intervention Name(s)
Liproca Depot
Intervention Description
Ready made paste including 600 mg 2-HOF for injection as a single dose
Intervention Type
Drug
Intervention Name(s)
2-Hydroxyflutamide
Other Intervention Name(s)
Liproca Depot
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of Patients Showing PSA Nadir
Description
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.
Time Frame
Measured every 4th week until progression or maximum 6 months.
Secondary Outcome Measure Information:
Title
Number of Patients Reporting Adverse Events Caused by the Study Treatment
Description
Adverse events caused by the study treatment
Abnormal, clinically relevant, laboratory parameters
Voiding symptoms
Vital Signs
Quality of Life
Time Frame
Measured every 4th week till progression or maximum 6 months
Title
Percent Change in Prostate Volume From Baseline to Nadir.
Description
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.
Time Frame
Measured every 4th week until progression or maximum 6 months.
Title
Time to PSA Nadir
Description
Time frame was from baseline to day of PSA nadir.
Time Frame
Measured every 4th week until progression or maximum 6 moths.
Title
Percent Change in Prostate Volume From Baseline to Final Visit
Description
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
Time Frame
Measured every 4th week until progresion or maximum 6 months.
Title
Number of Days to Prostate Volume Nadir.
Description
Number of Days from day of injection to prostate volume nadir.
Time Frame
Measured every 4th week until progression or maximum 6 months.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teuvo Tammela, Professor
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
An Efficacy and Safety Study With Licroca Depot, a Controlled Release Product, Injected Into the Prostate
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