Phase 2
N=24
An Efficacy and Safety Study With Licroca Depot, a Controlled Release Product, Injected Into the Prostate
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00913263 ↗Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Jan 2015
Primary outcome: Primary: Proportion of Patients Showing PSA Nadir — 83 percentage of patients with PSA nadir
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 2-hydroxyflutamide (2-HOF) [Liproca Depot] (Drug); 2-Hydroxyflutamide (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Male
- Sponsor
- Lidds AB
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Showing PSA Nadir |
83 | — |
| SECONDARY Number of Patients Reporting Adverse Events Caused by the Study Treatment |
12 | — |
| SECONDARY Percent Change in Prostate Volume From Baseline to Nadir. |
14 | — |
| SECONDARY Time to PSA Nadir |
77 | — |
| SECONDARY Percent Change in Prostate Volume From Baseline to Final Visit |
7 | — |
| SECONDARY Number of Days to Prostate Volume Nadir. |
112 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 45years
- Histologically confirmed localized prostate cancer (T1-T2), predominantly in one side of the peripheral zone, verified by biopsy.
- PSA value 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.
Data sourced from ClinicalTrials.gov (NCT00913263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.