An Efficacy and Safety Study With Licroca Depot, a Controlled Release Product, Injected Into the Prostate (2-HOF)

• ClinicalTrials.gov Identifier: NCT00913263
• Recruitment Status: Completed
• First Posted: June 4, 2009
• Results First Posted: January 19, 2015
• Last Update Posted: January 19, 2015
• Sponsor: Lidds AB
• Information provided by (Responsible Party): Lidds AB

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostate Cancer
• Interventions: Drug: 2-hydroxyflutamide (2-HOF) [Liproca Depot]; Drug: 2-Hydroxyflutamide
• Enrollment: 24

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.

Arm/Group Title	Hydroxyflutamide (2-HOF)
Arm/Group Description	Men with histologically confirmed localized prostate cancer (T1-T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
Period Title: Overall Study
Started	24
Completed	24
Not Completed	0

Baseline Characteristics

Arm/Group Title		Group 1
Arm/Group Description		Men with histologically confirmed localized prostate cancer (T1-T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
Overall Number of Baseline Participants		24
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	24 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	0 0.0%
	>=65 years	24 100.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	24 participants
		68 (5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	24 participants
	Female	0 0.0%
	Male	24 100.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Finland	Number Analyzed	24 participants
		24

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

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/Group Title	Part I
Arm/Group Description:	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.
Overall Number of Participants Analyzed	24
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of patients with PSA nadir
	83; (63 to 95)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Group 1
Arm/Group Description:	24 patients (Part I of the study) have been injected with Liproca Depot once.
Overall Number of Participants Analyzed	24
Measure Type: Number; Unit of Measure: Patients reporting study related AE
	12

3. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part I
Arm/Group Description:	Patients (24 patients) in Part I have been injected with Liproca Depot once.
Overall Number of Participants Analyzed	24
Median (Standard Deviation); Unit of Measure: percent change
	14 (9.6)

4. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part I
Arm/Group Description:	Patients () 24 patients) in Part I have been injected with Liproca Depot once.
Overall Number of Participants Analyzed	24
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Number of days from baseline to PSA nadi
	77; (32 to 126)

5. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part I
Arm/Group Description:	Patients () 24 patients) in Part I have been injected with Liproca Depot once.
Overall Number of Participants Analyzed	24
Median (Standard Deviation); Unit of Measure: percentage change
	7 (11)

6. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part 1
Arm/Group Description:	Patients (24 patients) have been injected with Liproca depot once
Overall Number of Participants Analyzed	24
Median (95% Confidence Interval); Unit of Measure: Days
	112; (21 to 184)

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Group 1
Arm/Group Description	Men with histologically confirmed localized prostate cancer (T1-T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
All-Cause Mortality
	Group 1
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Group 1
	Affected / at Risk (%)	# Events
Total	1/24 (4.17%)
Infections and infestations
Prostate infection * [1]	1/24 (4.17%)	1
* Indicates events were collected by non-systematic assessment; [1] The event was caused by the injectiontechnique
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	4%
	Group 1
	Affected / at Risk (%)	# Events
Total	12/24 (50.00%)
Renal and urinary disorders
dysuria, haematuria †	12/24 (50.00%)	16
† Indicates events were collected by systematic assessment

Limitations and Caveats

There were no limitations of the trial

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Teuvo Tammela, Professor
• Organization: Dept. of Surgery, Tampere University Hospital, Tampere, Finland
• Phone: +358-3-31164621
• EMail: teuvo.tammela@uta.fi

• Responsible Party: Lidds AB
• ClinicalTrials.gov Identifier: NCT00913263
• Other Study ID Numbers: LPC-002; 2009-010079-25 ( EudraCT Number )
• First Submitted: June 3, 2009
• First Posted: June 4, 2009
• Results First Submitted: April 22, 2013
• Results First Posted: January 19, 2015
• Last Update Posted: January 19, 2015