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 Description

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: 2-hydroxyflutamide (2-HOF) [Liproca Depot]; Drug: 2-Hydroxyflutamide	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: June 2009
• Actual Primary Completion Date: May 2011
• Actual Study Completion Date: July 2011

Arms and Interventions

Arm

Intervention/treatment

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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
2. 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.
3. 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.
4. 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
5. 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.

Eligibility Criteria

• Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
• Sexes 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

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

More Information

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

Keywords provided by Lidds AB:

Prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases; Flutamide; Hydroxyflutamide; Androgen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents