Trial Outcomes & Findings for An Efficacy and Safety Study With Licroca Depot, a Controlled Release Product, Injected Into the Prostate (NCT NCT00913263)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Measured every 4th week until progression or maximum 6 months.

Results posted on

2015-01-19

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=24 Participants Men with histologically confirmed localized prostate cancer (T1-T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants
Age, Continuous	68 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Region of Enrollment Finland	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part I n=24 Participants Patients () 24 patients) in Part I have been injected with Liproca Depot once. Patients in Part II (9 patients)have been injected twice with Liproca Depot. The second injection was after progression in Part I.
Proportion of Patients Showing PSA Nadir	83 percentage of patients with PSA nadir Interval 63.0 to 95.0

SECONDARY outcome

Timeframe: 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.

* Adverse events caused by the study treatment * Abnormal, clinically relevant, laboratory parameters * Voiding symptoms * Vital Signs * Quality of Life

Outcome measures

Outcome measures
Measure	Part I n=24 Participants Patients () 24 patients) in Part I have been injected with Liproca Depot once. Patients in Part II (9 patients)have been injected twice with Liproca Depot. The second injection was after progression in Part I.
Number of Patients Reporting Adverse Events Caused by the Study Treatment	12 Patients reporting study related AE

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Part I n=24 Participants Patients () 24 patients) in Part I have been injected with Liproca Depot once. Patients in Part II (9 patients)have been injected twice with Liproca Depot. The second injection was after progression in Part I.
Percent Change in Prostate Volume From Baseline to Nadir.	14 percent change Standard Deviation 9.6

SECONDARY outcome

Timeframe: Measured every 4th week until progression or maximum 6 moths.

Time frame was from baseline to day of PSA nadir.

Outcome measures

Outcome measures
Measure	Part I n=24 Participants Patients () 24 patients) in Part I have been injected with Liproca Depot once. Patients in Part II (9 patients)have been injected twice with Liproca Depot. The second injection was after progression in Part I.
Time to PSA Nadir	77 Number of days from baseline to PSA nadi Interval 32.0 to 126.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Part I n=24 Participants Patients () 24 patients) in Part I have been injected with Liproca Depot once. Patients in Part II (9 patients)have been injected twice with Liproca Depot. The second injection was after progression in Part I.
Percent Change in Prostate Volume From Baseline to Final Visit	7 percentage change Standard Deviation 11

SECONDARY outcome

Timeframe: Measured every 4th week until progression or maximum 6 months.

Number of Days from day of injection to prostate volume nadir.

Outcome measures

Outcome measures
Measure	Part I n=24 Participants Patients () 24 patients) in Part I have been injected with Liproca Depot once. Patients in Part II (9 patients)have been injected twice with Liproca Depot. The second injection was after progression in Part I.
Number of Days to Prostate Volume Nadir.	112 Days Interval 21.0 to 184.0

Adverse Events

Group 1

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 n=24 participants at risk Men with histologically confirmed localized prostate cancer (T1-T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
Infections and infestations Prostate infection	4.2% 1/24 • Number of events 1 • 6 months

Other adverse events

Other adverse events
Measure	Group 1 n=24 participants at risk Men with histologically confirmed localized prostate cancer (T1-T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
Renal and urinary disorders dysuria, haematuria	50.0% 12/24 • Number of events 16 • 6 months

Additional Information

Teuvo Tammela, Professor

Dept. of Surgery, Tampere University Hospital, Tampere, Finland

Phone: +358-3-31164621

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place