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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010079-25 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-Hydroxyflutamide | Experimental | Single injection of 2-Hydroxyflutamide (2-8mL ready-made paste)in one prostate lobe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-hydroxyflutamide (2-HOF) [Liproca Depot] | Drug | Ready made paste including 600 mg 2-HOF for injection as a single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured every 4th week until progression or maximum 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Reporting Adverse Events Caused by the Study Treatment |
| Measured every 4th week till progression or maximum 6 months |
| Percent Change in Prostate Volume From Baseline to Nadir. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teuvo Tammela, Professor | Tampere University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere University Hospital | Tampere | 33520 | Finland | |||
| Tampere University Hospital |
There was only one Group assignment for the study. The patients (men with histologically confirmed localized prostate cancer, verifyed by biopsy), aged ≥ 45 years, with PSA value <20ng/mL, within 6 weeks before enrollment, and and Gleason score <3+4 at diagnostic biopsy.
Patients were recruited from the pool of patients with prostate cancer (T1-T2) available at the clinic. They were informed about the study by the Investigator
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydroxyflutamide (2-HOF) | Men with histologically confirmed localized prostate cancer (T1-T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Men with histologically confirmed localized prostate cancer (T1-T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All patients who received the single dose of Liproca® Depot and had a baseline plasma PSA measurement, and at least one PSA measurement after the baseline measurement, were included in the efficacy analysis. Study population safety All patients who received at least one dose of Liproca® Depot were included in the safety analysis. | Posted | Number | 95% Confidence Interval | percentage of patients with PSA nadir | Measured every 4th week until progression or maximum 6 months. |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Men with histologically confirmed localized prostate cancer (T1-T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prostate infection | Infections and infestations | Non-systematic Assessment | The event was caused by the injectiontechnique |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dysuria, haematuria | Renal and urinary disorders | Systematic Assessment |
There were no limitations of the trial
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Teuvo Tammela, Professor | Dept. of Surgery, Tampere University Hospital, Tampere, Finland | +358-3-31164621 | teuvo.tammela@uta.fi |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C014290 | hydroxyflutamide |
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| 2-Hydroxyflutamide | 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. |
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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. |
| Measured every 4th week until progression or maximum 6 months. |
| Time to PSA Nadir | Time frame was from baseline to day of PSA nadir. | Measured every 4th week until progression or maximum 6 moths. |
| 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 | Measured every 4th week until progresion or maximum 6 months. |
| Number of Days to Prostate Volume Nadir. | Number of Days from day of injection to prostate volume nadir. | Measured every 4th week until progression or maximum 6 months. |
| Tampere |
| Finland |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Secondary | Number of Patients Reporting Adverse Events Caused by the Study Treatment |
| All patients who received the single dose of Liproca® Depot and had a baseline plasma PSA measurement, and at least one PSA measurement after the baseline measurement, should be included in the efficacy analysis. Study population safety All patients who received at least one dose of Liproca® Depot should be included in the safety analysis. | Posted | Number | Patients reporting study related AE | Measured every 4th week till progression or maximum 6 months |
|
|
|
| Secondary | 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. | Posted | Median | Standard Deviation | percent change | Measured every 4th week until progression or maximum 6 months. |
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|
|
| Secondary | Time to PSA Nadir | Time frame was from baseline to day of PSA nadir. | Posted | Number | 95% Confidence Interval | Number of days from baseline to PSA nadi | Measured every 4th week until progression or maximum 6 moths. |
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|
|
| Secondary | 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 | Posted | Median | Standard Deviation | percentage change | Measured every 4th week until progresion or maximum 6 months. |
|
|
|
| Secondary | Number of Days to Prostate Volume Nadir. | Number of Days from day of injection to prostate volume nadir. | Posted | Median | 95% Confidence Interval | Days | Measured every 4th week until progression or maximum 6 months. |
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| 1 |
| 24 |
| 12 |
| 24 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |