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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lidds AB
ClinicalTrials.gov Identifier:
NCT00913263
First received: June 3, 2009
Last updated: January 15, 2015
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: 2-hydroxyflutamide (2-HOF) [Liproca Depot]
Drug: 2-Hydroxyflutamide
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Lidds AB:

Primary Outcome Measures:
  • Proportion of Patients Showing PSA Nadir [ Time Frame: Measured every 4th week until progression or maximum 6 months. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Number of Patients Reporting Adverse Events Caused by the Study Treatment [ Time Frame: Measured every 4th week till progression or maximum 6 months ] [ Designated as safety issue: Yes ]
    • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Number of Days from day of injection to prostate volume nadir.


Enrollment: 24
Study Start Date: June 2009
Study Completion Date: July 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2-Hydroxyflutamide
Single injection of 2-Hydroxyflutamide (2-8mL ready-made paste)in one prostate lobe
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

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913263

Locations
Finland
Tampere University Hospital
Tampere, Finland, 33520
Tampere University Hospital
Tampere, Finland
Sponsors and Collaborators
Lidds AB
Investigators
Principal Investigator: Teuvo Tammela, Professor Tampere University Hospital Tampere Finland
  More Information

No publications provided

Responsible Party: Lidds AB
ClinicalTrials.gov Identifier: NCT00913263     History of Changes
Other Study ID Numbers: LPC-002, 2009-010079-25
Study First Received: June 3, 2009
Results First Received: April 22, 2013
Last Updated: January 15, 2015
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Lidds AB:
Prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Flutamide
Hydroxyflutamide
Androgen Antagonists
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on March 26, 2015