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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Lidds AB.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lidds AB
ClinicalTrials.gov Identifier:
NCT00913263
First received: June 3, 2009
Last updated: February 8, 2010
Last verified: February 2010
  Purpose

Men, 45 years of age or older, with localized prostate cancer will be injected once with a ready made paste including 600 mg 2-hydroxyflutamide (Liproca Depot) into the site of the prostate where the tumour is localized. The patient will be monitored for prostate-specific antigen (PSA) for maximum 6 months or to progression within this time period. Patients that progress within 3-6 months after the injection will be offered a second injection.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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: Every 4th week. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events caused by the study treatment [ Time Frame: Every 4th week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: June 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  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

Contacts
Contact: Teuvo Tammela, Professor +358 3 31164621 teuvo.tammela@uta.fi

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

No publications provided

Responsible Party: Lars Åke Malmsten, Lidds AB
ClinicalTrials.gov Identifier: NCT00913263     History of Changes
Other Study ID Numbers: LPC-002, 2009-010079-25
Study First Received: June 3, 2009
Last Updated: February 8, 2010
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Lidds AB:
Localized prostate cancer

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

ClinicalTrials.gov processed this record on August 28, 2014