Prostate CancerPhase 2NCT02341404
A Study of 2-hydroxyflutamide (Liproca Depot), Injected Into the Prostate in Patients With Localized Prostate Cancer
A Phase 2 study testing 2-hydroxyflutamide (2-HOF) in people with Prostate Cancer, run by Lidds AB at 2 sites in 2 countries.
Trial summary
The primary aim of the study was to characterize and quantify the histopathological changes in the surgical specimens obtained in patients undergoing prostatectomy in addition to imaging changes (MRI) following a single injection of Liproca Depot in patients with localized prostate cancer. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 2-hydroxyflutamide (2-HOF)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2012to May 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years, ≤ 75 years
- Histologically confirmed localized (stage T1c, T2a-T2c) prostate cancer that is judged relevant for prostatectomy.
- PSA value < 20 ng/ml within 6 weeks before enrolment.
- Gleason score ≤ 3+4 at diagnostic biopsy (or preferably with more precise method for judging the localization of the primary tumour focus (foci).
- Adequate renal function: Creatinine < 1.5 times upper limit of normal.
- Adequate hepatic function: Aspartate Transaminase (ASAT), Alanine Transaminase (ALAT) and Alkalase Phosphatase (ALP) < 1.5 times upper limit of normal.
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- Negative dipstick for bacteriuria.
- Patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit.
- Patients that has been scheduled for prostatectomy
Who cannot join
- Ongoing or previous hormone therapy for prostate cancer.
- On-going or previous therapy within 12 month of finasteride or dutasteride.
- On-going or previous invasive therapy for benign prostate hyperplasia (TURP, TUMT).
- Use of pace maker or other electronic devices
- Symptoms or signs of acute prostatitis.
- Symptoms or signs of ulcered proctitis
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- Severe micturation symptoms
- On-going therapy with anticoagulant (e.g Warfarin. Other anticoagulant should be withdrawn 1 week before injection).
- Concomitant systemic treatment with corticosteroids, or immune modulating agents.
- Known immunosuppressive disease (e.g. HIV, 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 2 countries.
2 sites in 2 countries
Sweden1 site
Dept of Urology, University Hospital
Uppsala, Uppsala County, 756 53
About this study
Official title: An Open, Single Dose, Antitumour Effect Study of 2-hydroxy-flutamide as a Controlled Release Product (Liproca Depot), Injected Into the Prostate in Patients With Localized Prostate Cancer
The primary aim of the study was to characterize and quantify the histopathological changes in the surgical specimens obtained in patients undergoing prostatectomy in addition to imaging changes (MRI) following a single injection of Liproca Depot in patients with localized prostate cancer.
Read the detailed description
The primary aim of the study was to characterize and quantify the histopathological changes in the surgical specimens obtained in patients undergoing prostatectomy in addition to imaging changes (MRI) following a single injection of Liproca Depot in patients with localized prostate cancer.
The secondary aims ere to evaluate efficacy and safety of a single injection of Liproca Depot, and to follow the pharmacokinetic profile.
- Conditions
- Prostate Cancer
- Being tested
- 2-hydroxyflutamide (2-HOF)
- 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)Drug
Also called Liproca Depot
Two components are mixed, transferred to a syringe and administered with injection into the prostate
| Study group | Role | What they receive |
|---|---|---|
| Liproca Depot | Experimental | A parenteral controlled release depot formulation of 2-hydroxyflutamide (2-HOF) is given as a single dose injection into the prostate gland within the lobe area where the tumour tissue is localized. Receives: Drug: 2-hydroxyflutamide (2-HOF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization and quantification of histopathological measurement of tumour tissue obtained from diagnostic biopsy.
Measured: Day 1
Characterization and quantification of histopathological measurement of tumour tissue in surgical specimens obtained from patients undergoing prostatectomy
Measured: Six weeks
The diffusion/flow of tissue water (ADC) before and after treatment assessed by diffusion-weighted imaging (MRI)
Measured: Six weeks
Secondary outcomes (7)
Concentration of Choline, Creatinine and Citrate in tumour tissue before and after treatment
Measured: Six weeks
Surface fraction and volume of treated tumour focus (foci) based on MRI and histopathological map from surgical specimens at baseline and end of study, respectively
Measured: Six weeks
Concentration of Plasma Prostate Specific Antigen (PSA)
Measured: Six weeks
Total prostate volume by histopathology/MRI measúrements
Measured: Six weeks
Number of participants with Adverse Events as a measure of Safety and Tolerability
Measured: Six weeks
Number of abnormal, clinically relevant, parameters from laboratory analyses
Measured: Six weeks
Pharmacokinetics (Tmax and Cmax) of 2-hydroxyflutamide (2-HOF)
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startMay 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lidds AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Uppsala University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341404
- Sponsor's protocol ID
- LPC-003
- Status last verified
- Mar 2016
- First submitted
- 17 Oct 2014
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single Dose, Antitumour Effect Study of 2-hydroxy-flutamide as a Controlled Release Product (Liproca Depot), Injected Into the Prostate in Patients With Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT02341404
- Acronym / sponsor ID
- LPC-003
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Lidds ABIndustry (pharma, biotech, devices)
- Collaborators
- Uppsala University
- Study start
- May 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the study was to characterize and quantify the histopathological changes in the surgical specimens obtained in patients undergoing prostatectomy in addition to imaging changes (MRI) following a single injection of Liproca Depot in patients with localized prostate cancer.
Detailed description
The primary aim of the study was to characterize and quantify the histopathological changes in the surgical specimens obtained in patients undergoing prostatectomy in addition to imaging changes (MRI) following a single injection of Liproca Depot in patients with localized prostate cancer.
The secondary aims ere to evaluate efficacy and safety of a single injection of Liproca Depot, and to follow the pharmacokinetic profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liproca Depot | Experimental | Drug: 2-hydroxyflutamide (2-HOF)A parenteral controlled release depot formulation of 2-hydroxyflutamide (2-HOF) is given as a single dose injection into the prostate gland within the lobe area where the tumour tissue is localized. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 50 years, ≤ 75 years
- Histologically confirmed localized (stage T1c, T2a-T2c) prostate cancer that is judged relevant for prostatectomy.
- PSA value < 20 ng/ml within 6 weeks before enrolment.
- Gleason score ≤ 3+4 at diagnostic biopsy (or preferably with more precise method for judging the localization of the primary tumour focus (foci).
- Adequate renal function: Creatinine < 1.5 times upper limit of normal.
Key exclusion criteria (11 listed)
- Ongoing or previous hormone therapy for prostate cancer.
- On-going or previous therapy within 12 month of finasteride or dutasteride.
- On-going or previous invasive therapy for benign prostate hyperplasia (TURP, TUMT).
- Use of pace maker or other electronic devices
- Symptoms or signs of acute prostatitis.
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)Also: Liproca DepotTwo components are mixed, transferred to a syringe and administered with injection into the prostate | Drug | Liproca Depot |
Primary outcome
Characterization and quantification of histopathological measurement of tumour tissue obtained from diagnostic biopsy.
Time frame: Day 1
Characterization and quantification of histopathological measurement of tumour tissue in surgical specimens obtained from patients undergoing prostatectomy
Time frame: Six weeks
The diffusion/flow of tissue water (ADC) before and after treatment assessed by diffusion-weighted imaging (MRI)
Time frame: Six weeks
7 secondary outcomes
Concentration of Choline, Creatinine and Citrate in tumour tissue before and after treatment
Time frame: Six weeks
Surface fraction and volume of treated tumour focus (foci) based on MRI and histopathological map from surgical specimens at baseline and end of study, respectively
Time frame: Six weeks
Concentration of Plasma Prostate Specific Antigen (PSA)
Time frame: Six weeks
Total prostate volume by histopathology/MRI measúrements
Time frame: Six weeks
Number of participants with Adverse Events as a measure of Safety and Tolerability
Time frame: Six weeks
Number of abnormal, clinically relevant, parameters from laboratory analyses
Time frame: Six weeks
Pharmacokinetics (Tmax and Cmax) of 2-hydroxyflutamide (2-HOF)
Time frame: Six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2-hydroxyflutamide (2-HOF) in people with Prostate Cancer, run by Lidds AB at 2 sites in 2 countries.
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 9 inclusion and 11 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 11 Mar 2016. 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, Sweden. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Characterization and quantification of histopathological measurement of tumour tissue obtained from diagnostic biopsy. (time frame: Day 1). The study lists 3 primary outcomes in all. 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 11 Mar 2016.