Prostate CancerPhase 2NCT03348527
A Study to Evaluate the Safety, Tolerability and Efficacy of a Liproca® Depot Injection in Patients With Prostate Cancer
A Phase 2 study testing 2-Hydroxyflutamide Depot in people with Prostate Cancer, run by Lidds AB at 10 sites in 3 countries.
Trial summary
A Single Blind, Two-Stage Dose Finding Study to Evaluate the Safety, Tolerability and Efficacy of a Single Liproca® Depot Injection into the Prostate in Patients with Localized Prostate Cancer,Assigned to Active Surveillance who are at High Risk for Disease Progression (followed by an Open Label Extension with a… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 2-Hydroxyflutamide Depot
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 12 May 2017to 30 Nov 2020
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to any study specific procedures being performed
- 18 - 80 years of age, inclusive
- Assigned to Active Surveillance
- Histologically confirmed, localized prostate cancer within 24 months of Screening
- Gleason score 3+3 or 3+4 with one or more of the following characteristics:
- PSA > 6.0 μg/L (ng/mL) and PSA density > 0.15; PSA > 10.0 μg/L and < 20 μg/L (ng/mL); Any systematic core > 50% involvement; Any PI-RADS score 4 or 5 on MRI; Any Gleason grade 4, Men of African descent
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- Patient has a negative bone scan within the last 12 months
- Patient is able to have an MRI
- Prostate volume ≤ 80 mL (measured by MRI within 12 months of Screening or has been scheduled for an MRI prior to Screening)
- eGFR ≥ 30 mL/min, using the Cockcroft - Gault Equation: = [{(140 - age in years) x (weight in kg)} x 1.23] / serum Creatinine in micromol/l
- AST, ALT and ALP ≤ 1.5 times upper limit of normal
- Patient must be willing to comply with all study procedures
- Patients must agree to the use of medically acceptable methods of contraception, including non-hormonal intrauterine device (IUD) or double barrier method (condom with foam or vaginal spermicidal suppository, diaphragm with spermicide) for the duration of the study (24 weeks), unless the patient and/or their partner has been surgically sterilized
Who cannot join
- PSA > 20 μg/L (ng/mL)
- Previous or ongoing hormonal therapy for prostate cancer
- Positive urine culture before treatment with prophylactic antibiotics
- Ongoing or previous therapy with finasteride or dutasteride in the last 3 months
- Ongoing or previous invasive therapy for benign prostate hyperplasia (BPH) (e.g. TURP,TUMT, HIFU, etc.)
- Use of pacemaker or other implanted electronic devices
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- Metal implant in the pelvis (e.g. hip replacement) that may affect the MRI of the prostate
- Allergy to Liproca® Depot and its ingredients
- Severe micturition symptoms (I-PSS >15 or residual urine volume > 150 mL) confirmed by repeat measurement or Qmax< 12 mL/s
- Ongoing therapy with the anticoagulant Acetyl Salicylic Acid (ASA) (more than 100mg/day) as preventive anti-thrombotic therapy should be withdrawn temporarily before treatment with Liproca® Depot, as determined by the Investigator. Other anticoagulants should be withdrawn in cooperation with the treating physician
- Use of any previous focal prostate cancer treatment, such as transurethral resection, cryotherapy, high intensity frequency ultrasound (HIFU) and/or photodynamic therapy
- Concomitant systemic treatment with corticosteroids or immune modulating agents
- Known immunosuppressive disease (e.g. HIV, Type II Diabetes). Patients with well controlled Type II Diabetes may be included, as determined by Investigator
- Simultaneous participation in any other study involving an investigational product or device,or having participated in a prostate cancer study within the last 12 months prior to starting treatment with Liproca® Depot
- Infection in WHO Risk Group 2, 3 or 4
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Canada6 sites
Jonathan Giddens Medicine Professional Corporation
Brampton, Ontario, L6T 4S5
G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, L7N 3V2
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2Y9
The Fe/Male Health Centres
Oakville, Ontario, L6H 3 P1
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, J1H 5N4
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Finland2 sites
Helsinki University Hospital
Helsinki, FIN-00100
Tampere University Hospital
Tampere, FI-33521
Lithuania2 sites
Hospital of Lithuanian University of Health Sciences
Kaunas, 50161
National Cancer Institute - Oncourology Department
Vilnius, 08660
About this study
Official title: A Single Blind, Two-Stage Dose Finding Study to Evaluate the Safety, Tolerability and Efficacy of a Single Liproca® Depot Injection Into the Prostate in Patients With Localized Prostate Cancer, Assigned to Active Surveillance Who Are at High Risk for Disease Progression (Followed by an Open Label Extension With a Repeat Injection (Optional)).
A Single Blind, Two-Stage Dose Finding Study to Evaluate the Safety, Tolerability and Efficacy of a Single Liproca® Depot Injection into the Prostate in Patients with Localized Prostate Cancer,Assigned to Active Surveillance who are at High Risk for Disease Progression (followed by an Open Label Extension with a Repeat Injection (Optional))
Read the detailed description
Patients assigned to Active Surveillance and who have fulfilled all inclusion criteria will receive a prophylactic antibiotic and a local anaesthetic (according to the Investigator's Standard of Care) prior to administration of Liproca® Depot.
60 subjects will be enrolled.
The Single Dose Study will be conducted in two stages:
In Stage I, 20 subjects will be randomized into two groups to receive one dose of Liproca® Depot equal to 35% (Cohort 1) or 45 % (Cohort 2) of their prostate volume (mL) (N=10:10). Two weeks after all subjects have received their initial dose, the Data Safety Monitoring Board (DSMB) will review the subjects' safety and tolerability data over the first 14 days after receiving treatment.
In Stage II, 40 subjects will be randomized to receive either 16mL (Cohort 3) or 20mL (Cohort 4) of Liproca® Depot.
All subjects in Stage I and Stage II will be followed for 24 weeks.
Subjects who complete the Single Dose Study and who experience no safety or tolerability issues, as determined by the Investigator, may be offered an option to participate in the Open Label Extension Study (OLE). Subjects enrolled in the OLE will be observed for PSA recurrence every 8 weeks. If PSA recurrence is confirmed (defined as a PSA level exceeding at least 100 % of Baseline value) subjects will receive a second treatment of Liproca® Depot. The dose will be injected into the tumour focus/foci and in close proximity to the tumour, based on a prostate biopsy (and MRI, if applicable), using a TRUS for guidance.
Stage I subjects who received 35% volume of Liproca® Depot will receive 16 mL and subjects who received 45% volume of Liproca® Depot will receive 20 mL. Stage II subjects will receive the same dose of Liproca® Depot that was administered in the first treatment.
Subjects in the OLE receiving a second injection will be followed up for an additional 24 weeks for safety, tolerability and efficacy. After this period, subjects may undergo MRI imaging and a prostate biopsy.
- Conditions
- Prostate Cancer
- Being tested
- 2-Hydroxyflutamide Depot
- 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 DepotDrug
Also called Liproca® Depot Injection
Liproca® Depot is a depot formulation containing a bioresorbable, controlled-release,formulation of the nonsteroidal antiandrogen 2-hydroxyflutamide
| Study group | Role | What they receive |
|---|---|---|
| Stage I: Dose = 35% of prostate volume | Experimental | Subject will be randomized into a group receiving one dose of 2-hydroxyflutamide depot (Liproca® Depot) equal to 35 % of their prostate volume. Receives: Drug: 2-Hydroxyflutamide Depot |
| Stage I: Dose = 45% of prostate volume | Experimental | Subject will be randomized into a group receiving one dose of 2-hydroxyflutamide depot (Liproca® Depot) equal to 45 % of their prostate volume. Receives: Drug: 2-Hydroxyflutamide Depot |
| Stage II: Dose = 16mL | Experimental | Subject will be randomized into a group receiving one dose of 2-hydroxyflutamide depot (Liproca® Depot) equal to 16mL Receives: Drug: 2-Hydroxyflutamide Depot |
| Stage II: Dose = 20mL | Experimental | Subject will be randomized into a group receiving one dose of 2-hydroxyflutamide depot (Liproca® Depot) equal to 20mL Receives: Drug: 2-Hydroxyflutamide Depot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highest Tolerable Dose of Liproca Depot
To define the highest tolerable dose of Liproca Depot for transrectal injection into the prostate.
Measured: 24 weeks
Secondary outcomes (9)
Liproca Depot Effect on Prostate Specific Antigen Levels
To determine the absolute level and % decrease of PSA level at Week 8, 16, 20 and 24, and PSA nadir.
Measured: 24 weeks
Liproca Depot Effect on Prostate Volume
To determine the effect on prostate volume at Week 20 after treatment with one of four doses of Liproca Depot based on an MRI evaluation. Measured by %decrease versus Baseline and as absolute values.
Measured: 20 weeks
Evaluation of Lesions
MRI evaluation of Lesions based on PI-RADS (Prostate Imaging Reporting and Data System) score 20 weeks after treatment with one of four doses of Liproca Depot.
Measured: 20 weeks
Quality of Life (QoL) Questionnaire Score
Assessment of QoL Questionnaire scores at Baseline, Week 8,16,20 and 24 after treatment with one of four doses of Liproca Depot.
Measured: 24 weeks
Micturition Status using the International Prostate Symptom Score (I-PSS)
Micturition status will be assessed using the I-PSS Questionnaire at Week 8, 20 and 24 after treatment with one of four doses of Liproca Depot.
Measured: 24 weeks
Frequency of Adverse Events
All adverse events related to Liproca Depot or its administration, incidence of AEs, withdrawals due to AEs and all Serious Adverse Events (SAEs) will be assessed. All adverse events will be reported and followed until resolved or until, in the Investigator's opinion, the condition has become stable and is unlikely to change further.
Measured: 24 weeks
Change in Testosterone Levels
Testosterone levels (nmol/L) will be assessed at Baseline, Week 8 and 24 after treatment with one of four doses of Liproca Depot.
Measured: 24 weeks
Systematic Exposure of 2-hydroxyflutamide
To examine the systematic exposure of 2-hydroxyflutamide at Baseline, Hour 2, Day 2,4,7 and 14, week 8 and end of study for all subjects in Phase I and a subset of 12 subjects in Stage II.
Measured: 24 weeks
Pharmacokinetics of 2-hydroxyflutamide
To examine the pharmacokinetics of 2-hydroxyflutamide at Baseline, Hour 2, Day 2,4,7 and 14, week 8 and end of study for all subjects in Phase I and a subset of 12 subjects in Stage II.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start12 May 2017
- Primary completion30 Oct 2020
- Study completion30 Nov 2020
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stage I: 20 Subjects will be enrolled into one of two groups, each receiving a single dose of Liproca®Depot. The target treatment dose will be 35% (Cohort 1) or 45% (Cohort 2) of the prostate volume (mL). Stage II: 40 subjects will be randomized to receive either 16 mL (Cohort 3) or 20mL (Cohort 4) of Liproca®Depot.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lidds AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CMX Research
- Responsible party
- Sponsor
- Investigators
- Richard Casey, MD, Study director, CMX Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348527
- Sponsor's protocol ID
- LPC-004
- Status last verified
- Dec 2020
- First submitted
- 1 Nov 2017
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind, Two-Stage Dose Finding Study to Evaluate the Safety, Tolerability and Efficacy of a Single Liproca® Depot Injection Into the Prostate in Patients With Localized Prostate Cancer, Assigned to Active Surveillance Who Are at High Risk for Disease Progression (Followed by an Open Label Extension With a Repeat Injection (Optional)).
- ClinicalTrials.gov ID
- NCT03348527
- Acronym / sponsor ID
- LPC-004
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Lidds ABIndustry (pharma, biotech, devices)
- Collaborators
- CMX Research
- Study start
- 12 May 2017 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 21 Nov 2017 (actual)
- 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.
A Single Blind, Two-Stage Dose Finding Study to Evaluate the Safety, Tolerability and Efficacy of a Single Liproca® Depot Injection into the Prostate in Patients with Localized Prostate Cancer,Assigned to Active Surveillance who are at High Risk for Disease Progression (followed by an Open Label Extension with a Repeat Injection (Optional))
Detailed description
Patients assigned to Active Surveillance and who have fulfilled all inclusion criteria will receive a prophylactic antibiotic and a local anaesthetic (according to the Investigator's Standard of Care) prior to administration of Liproca® Depot.
60 subjects will be enrolled.
The Single Dose Study will be conducted in two stages:
In Stage I, 20 subjects will be randomized into two groups to receive one dose of Liproca® Depot equal to 35% (Cohort 1) or 45 % (Cohort 2) of their prostate volume (mL) (N=10:10). Two weeks after all subjects have received their initial dose, the Data Safety Monitoring Board (DSMB) will review the subjects' safety and tolerability data over the first 14 days after receiving treatment.
In Stage II, 40 subjects will be randomized to receive either 16mL (Cohort 3) or 20mL (Cohort 4) of Liproca® Depot.
All subjects in Stage I and Stage II will be followed for 24 weeks.
Subjects who complete the Single Dose Study and who experience no safety or tolerability issues, as determined by the Investigator, may be offered an option to participate in the Open Label Extension Study (OLE). Subjects enrolled in the OLE will be observed for PSA recurrence every 8 weeks. If PSA recurrence is confirmed (defined as a PSA level exceeding at least 100 % of Baseline value) subjects will receive a second treatment of Liproca® Depot. The dose will be injected into the tumour focus/foci and in close proximity to the tumour, based on a prostate biopsy (and MRI, if applicable), using a TRUS for guidance.
Stage I subjects who received 35% volume of Liproca® Depot will receive 16 mL and subjects who received 45% volume of Liproca® Depot will receive 20 mL. Stage II subjects will receive the same dose of Liproca® Depot that was administered in the first treatment.
Subjects in the OLE receiving a second injection will be followed up for an additional 24 weeks for safety, tolerability and efficacy. After this period, subjects may undergo MRI imaging and a prostate biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Stage I: 20 Subjects will be enrolled into one of two groups, each receiving a single dose of Liproca®Depot. The target treatment dose will be 35% (Cohort 1) or 45% (Cohort 2) of the prostate volume (mL). Stage II: 40 subjects will be randomized to receive either 16 mL (Cohort 3) or 20mL (Cohort 4) of Liproca®Depot.
| Arm | Type | Receives |
|---|---|---|
| Stage I: Dose = 35% of prostate volume | Experimental | Drug: 2-Hydroxyflutamide DepotSubject will be randomized into a group receiving one dose of 2-hydroxyflutamide depot (Liproca® Depot) equal to 35 % of their prostate volume. |
| Stage I: Dose = 45% of prostate volume | Experimental | Drug: 2-Hydroxyflutamide DepotSubject will be randomized into a group receiving one dose of 2-hydroxyflutamide depot (Liproca® Depot) equal to 45 % of their prostate volume. |
| Stage II: Dose = 16mL | Experimental | Drug: 2-Hydroxyflutamide DepotSubject will be randomized into a group receiving one dose of 2-hydroxyflutamide depot (Liproca® Depot) equal to 16mL |
| Stage II: Dose = 20mL | Experimental | Drug: 2-Hydroxyflutamide DepotSubject will be randomized into a group receiving one dose of 2-hydroxyflutamide depot (Liproca® Depot) equal to 20mL |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed informed consent prior to any study specific procedures being performed
- 18 - 80 years of age, inclusive
- Assigned to Active Surveillance
- Histologically confirmed, localized prostate cancer within 24 months of Screening
- Gleason score 3+3 or 3+4 with one or more of the following characteristics:
Key exclusion criteria (15 listed)
- PSA > 20 μg/L (ng/mL)
- Previous or ongoing hormonal therapy for prostate cancer
- Positive urine culture before treatment with prophylactic antibiotics
- Ongoing or previous therapy with finasteride or dutasteride in the last 3 months
- Ongoing or previous invasive therapy for benign prostate hyperplasia (BPH) (e.g. TURP,TUMT, HIFU, etc.)
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 DepotAlso: Liproca® Depot InjectionLiproca® Depot is a depot formulation containing a bioresorbable, controlled-release,formulation of the nonsteroidal antiandrogen 2-hydroxyflutamide | Drug | Stage I: Dose = 35% of prostate volume, Stage I: Dose = 45% of prostate volume, Stage II: Dose = 16mL, Stage II: Dose = 20mL |
Primary outcome
Highest Tolerable Dose of Liproca Depot
Time frame: 24 weeks
To define the highest tolerable dose of Liproca Depot for transrectal injection into the prostate.
9 secondary outcomes
Liproca Depot Effect on Prostate Specific Antigen Levels
Time frame: 24 weeks
Liproca Depot Effect on Prostate Volume
Time frame: 20 weeks
Evaluation of Lesions
Time frame: 20 weeks
Quality of Life (QoL) Questionnaire Score
Time frame: 24 weeks
Micturition Status using the International Prostate Symptom Score (I-PSS)
Time frame: 24 weeks
Frequency of Adverse Events
Time frame: 24 weeks
Change in Testosterone Levels
Time frame: 24 weeks
Systematic Exposure of 2-hydroxyflutamide
Time frame: 24 weeks
Pharmacokinetics of 2-hydroxyflutamide
Time frame: 24 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 21 Dec 2020.
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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.
Richard Casey, MD study director
CMX Research
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2-Hydroxyflutamide Depot in people with Prostate Cancer, run by Lidds AB at 10 sites in 3 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 13 inclusion and 15 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 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada, Finland, Lithuania. 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?
Highest Tolerable Dose of Liproca Depot (time frame: 24 weeks). 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 21 Dec 2020.