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

Tracking Information

• First Submitted Date: June 3, 2009
• First Posted Date: June 4, 2009
• Results First Submitted Date: April 22, 2013
• Results First Posted Date: January 19, 2015
• Last Update Posted Date: January 19, 2015
• Study Start Date: June 2009
• Actual Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 15, 2015)

Proportion of Patients Showing PSA Nadir [ Time Frame: 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.

• Original Primary Outcome Measures (submitted: June 3, 2009): Proportion of Patients Showing PSA Nadir [ Time Frame: Every 4th week. ]

Current Secondary Outcome Measures (submitted: January 15, 2015)

• Number of Patients Reporting Adverse Events Caused by the Study Treatment [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: Measured every 4th week until progression or maximum 6 months. ]
  Number of Days from day of injection to prostate volume nadir.

• Original Secondary Outcome Measures (submitted: June 3, 2009): Adverse events caused by the study treatment [ Time Frame: Every 4th week ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Efficacy and Safety Study With Licroca Depot, a Controlled Release Product, Injected Into the Prostate
• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostate Cancer

Intervention

• Drug: 2-hydroxyflutamide (2-HOF) [Liproca Depot]
  Ready made paste including 600 mg 2-HOF for injection as a single dose
  Other Name: Liproca Depot
• Drug: 2-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.
  Other Name: Liproca Depot

Study Arms

Experimental: 2-Hydroxyflutamide

Single injection of 2-Hydroxyflutamide (2-8mL ready-made paste)in one prostate lobe

Interventions:

• Drug: 2-hydroxyflutamide (2-HOF) [Liproca Depot]
• Drug: 2-Hydroxyflutamide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 3, 2009): 24
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2011
• Actual Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 45 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT00913263
• Other Study ID Numbers: LPC-002; 2009-010079-25 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Lidds AB
• Study Sponsor: Lidds AB
• Collaborators: Not Provided

Investigators

• Principal Investigator: Teuvo Tammela, Professor; Tampere University Hospital

• PRS Account: Lidds AB
• Verification Date: April 2013