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

NCT00913263 | Completed Phase 1 Results

• 2 other identifiers: LPC-0022009-010079-25
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Showing PSA Nadir

  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.

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

Secondary Outcomes (5)

• Number of Patients Reporting Adverse Events Caused by the Study Treatment

  Measured every 4th week till progression or maximum 6 months

• Percent Change in Prostate Volume From Baseline to Nadir.

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

• Time to PSA Nadir

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

• Percent Change in Prostate Volume From Baseline to Final Visit

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

• Number of Days to Prostate Volume Nadir.

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

Study Arms (1)

2-Hydroxyflutamide

EXPERIMENTAL

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

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

Interventions

2-hydroxyflutamide (2-HOF) [Liproca Depot] DRUG

Ready made paste including 600 mg 2-HOF for injection as a single dose

Also known as: Liproca Depot

2-Hydroxyflutamide

2-Hydroxyflutamide DRUG

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.

Also known as: Liproca Depot

2-Hydroxyflutamide

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 45years
• Histologically confirmed localized prostate cancer (T1-T2), predominantly in one side of the peripheral zone, verified by biopsy.
• PSA value \< 20 ng/ml within 6 weeks before enrolment.
• Gleason score ≤ 3+4 at diagnostic biopsy
• Adequate renal function: Creatinine \< 1.5 times upper limit of normal.
• Adequate hepatic function: ASAT, ALAT and ALP \< 1.5 times upper limit of normal.
• Negative dipstick for bacturia.
• Patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit.

You may not qualify if:

• Previous or ongoing hormone therapy for prostate cancer.
• Ongoing or previous therapy (within3 month) of finasteride or dutasteride.
• Ongoing or previous invasive therapy for benign prostate hyperplasia (TURP, TUMT).
• Symptoms or signs of acute prostatitis.
• Symptoms or signs of ulceric proctitis
• Severe micturation symptoms (I-PSS \>17)
• Concomitant systemic treatment with corticosteroids, or immunomodulating agents.
• Known immunosuppressive disease (e.g. HIV, insulin dependent diabetes).
• 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.

Sponsors & Collaborators

• Lidds AB: lead

Study Sites (2)

Tampere University Hospital

Tampere, 33520, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

hydroxyflutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

There were no limitations of the trial

Results Point of Contact

• Title: Teuvo Tammela, Professor
• Organization: Dept. of Surgery, Tampere University Hospital, Tampere, Finland

teuvo.tammela@uta.fi

+358-3-31164621

Study Officials

• Teuvo Tammela, Professor

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 4, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 19, 2015
• Results First Posted: January 19, 2015

Record last verified: 2013-04

Locations

FI (2)