Prostate Cancer
Conditions
Keywords
Prostate cancer
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.
Interventions
DRUG2-hydroxyflutamide (2-HOF) [Liproca Depot]
Ready made paste including 600 mg 2-HOF for injection as a single dose
DRUG2-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.
Sponsors
Lidds AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Time to PSA Nadir | Measured every 4th week until progression or maximum 6 moths. | Time frame was from baseline to day of PSA nadir. |
| 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 |
| 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. |
Countries
Finland
Participant flow
Recruitment details
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
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Group 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 68 years STANDARD_DEVIATION 5 |
| Region of Enrollment Finland | 24 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 24 |
| serious Total, serious adverse events | 1 / 24 |
Outcome results
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.
Time frame: Measured every 4th week until progression or maximum 6 months.
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part I | Proportion of Patients Showing PSA Nadir | 83 percentage of patients with PSA nadir |
Secondary
Number of Days to Prostate Volume Nadir.
Number of Days from day of injection to prostate volume nadir.
Time frame: Measured every 4th week until progression or maximum 6 months.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part I | Number of Days to Prostate Volume Nadir. | 112 Days |
Secondary
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
Time frame: Measured every 4th week till progression or maximum 6 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part I | Number of Patients Reporting Adverse Events Caused by the Study Treatment | 12 Patients reporting study related AE |
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
Time frame: Measured every 4th week until progresion or maximum 6 months.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Part I | Percent Change in Prostate Volume From Baseline to Final Visit | 7 percentage change | Standard Deviation 11 |
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.
Time frame: Measured every 4th week until progression or maximum 6 months.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Part I | Percent Change in Prostate Volume From Baseline to Nadir. | 14 percent change | Standard Deviation 9.6 |
Secondary
Time to PSA Nadir
Time frame was from baseline to day of PSA nadir.
Time frame: Measured every 4th week until progression or maximum 6 moths.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part I | Time to PSA Nadir | 77 Number of days from baseline to PSA nadi |