Prostate CancerPhase 1/22-HOFNCT00913263
An Efficacy and Safety Study With Licroca Depot, a Controlled Release Product, Injected Into the Prostate
A Phase 1/2 study testing 2-hydroxyflutamide (2-HOF) [Liproca Depot] and 2-Hydroxyflutamide in people with Prostate Cancer, run by Lidds AB at 2 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 2-hydroxyflutamide (2-HOF) [Liproca Depot] and 2-Hydroxyflutamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesFinland
- Study dates
- Jun 2009to Jul 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Tampere University Hospital
Tampere, 33520
Tampere University Hospital
Tampere
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- 2-hydroxyflutamide (2-HOF) [Liproca Depot], 2-Hydroxyflutamide
- Keywords
- Prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-hydroxyflutamide (2-HOF) [Liproca Depot]Drug
Also called Liproca Depot
Ready made paste including 600 mg 2-HOF for injection as a single dose
2-HydroxyflutamideDrug
Also called Liproca Depot
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.
| Study group | Role | What they receive |
|---|---|---|
| 2-Hydroxyflutamide | Experimental | Single injection of 2-Hydroxyflutamide (2-8mL ready-made paste)in one prostate lobe Receives: Drug: 2-hydroxyflutamide (2-HOF) [Liproca Depot]; Drug: 2-Hydroxyflutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured every 4th week until progression or maximum 6 months.
Secondary outcomes (5)
Number of Patients Reporting Adverse Events Caused by the Study Treatment
- Adverse events caused by the study treatment
- Abnormal, clinically relevant, laboratory parameters
- Voiding symptoms
- Vital Signs
- Quality of Life
Measured: Measured every 4th week till progression or maximum 6 months
Percent Change in Prostate Volume From Baseline to Nadir.
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.
Measured: Measured every 4th week until progression or maximum 6 months.
Time to PSA Nadir
Time frame was from baseline to day of PSA nadir.
Measured: Measured every 4th week until progression or maximum 6 moths.
Percent Change in Prostate Volume From Baseline to Final Visit
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
Measured: Measured every 4th week until progresion or maximum 6 months.
Number of Days to Prostate Volume Nadir.
Number of Days from day of injection to prostate volume nadir.
Measured: Measured every 4th week until progression or maximum 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lidds AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teuvo Tammela, Professor, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913263
- Sponsor's protocol ID
- LPC-002
- Other IDs
- 2009-010079-25, 2009
- Acronym
- 2-HOF
- Status last verified
- Apr 2013
- First submitted
- 3 Jun 2009
- Last updated
- 19 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00913263
- Acronym / sponsor ID
- 2-HOF / LPC-002
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lidds ABIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Posted 19 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2-Hydroxyflutamide | Experimental | Drug: 2-hydroxyflutamide (2-HOF) [Liproca Depot], Drug: 2-HydroxyflutamideSingle injection of 2-Hydroxyflutamide (2-8mL ready-made paste)in one prostate lobe |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-hydroxyflutamide (2-HOF) [Liproca Depot]Also: Liproca DepotReady made paste including 600 mg 2-HOF for injection as a single dose | Drug | 2-Hydroxyflutamide |
| 2-HydroxyflutamideAlso: Liproca DepotThe 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. | Drug | 2-Hydroxyflutamide |
Primary outcome
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.
5 secondary outcomes
Number of Patients Reporting Adverse Events Caused by the Study Treatment
Time frame: Measured every 4th week till progression or maximum 6 months
Percent Change in Prostate Volume From Baseline to Nadir.
Time frame: Measured every 4th week until progression or maximum 6 months.
Time to PSA Nadir
Time frame: Measured every 4th week until progression or maximum 6 moths.
Percent Change in Prostate Volume From Baseline to Final Visit
Time frame: Measured every 4th week until progresion or maximum 6 months.
Number of Days to Prostate Volume Nadir.
Time frame: Measured every 4th week until progression or maximum 6 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teuvo Tammela, Professor principal investigator
Tampere University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 2-hydroxyflutamide (2-HOF) [Liproca Depot] and 2-Hydroxyflutamide in people with Prostate Cancer, run by Lidds AB at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Showing PSA Nadir (time frame: Measured every 4th week until progression or maximum 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2015.