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A Study to Evaluate the Safety, Tolerability and Efficacy of a Liproca® Depot Injection in Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03348527
Recruitment Status : Unknown
Verified August 2018 by Lidds AB.
Recruitment status was:  Recruiting
First Posted : November 21, 2017
Last Update Posted : December 13, 2018
Sponsor:
Collaborator:
CMX Research
Information provided by (Responsible Party):
Lidds AB

Brief 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 Repeat Injection (Optional))

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 2-Hydroxyflutamide Depot Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Masking Description: Participant is blinded to whether they are receiving a treatment dose of 35% or 45% of total prostate volume in stage I or 16mL or 20mL in stage II.
Primary Purpose: Treatment
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)).
Actual Study Start Date : May 12, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Stage I: Dose = 35% of prostate volume
Subject will be randomized into a group receiving one dose of 2-hydroxyflutamide depot (Liproca® Depot) equal to 35 % of their prostate volume.
Drug: 2-Hydroxyflutamide Depot
Liproca® Depot is a depot formulation containing a bioresorbable, controlled-release,formulation of the nonsteroidal antiandrogen 2-hydroxyflutamide
Other Name: Liproca® Depot Injection

Experimental: Stage I: Dose = 45% of prostate volume
Subject will be randomized into a group receiving one dose of 2-hydroxyflutamide depot (Liproca® Depot) equal to 45 % of their prostate volume.
Drug: 2-Hydroxyflutamide Depot
Liproca® Depot is a depot formulation containing a bioresorbable, controlled-release,formulation of the nonsteroidal antiandrogen 2-hydroxyflutamide
Other Name: Liproca® Depot Injection

Experimental: Stage II: Dose = 16mL
Subject will be randomized into a group receiving one dose of 2-hydroxyflutamide depot (Liproca® Depot) equal to 16mL
Drug: 2-Hydroxyflutamide Depot
Liproca® Depot is a depot formulation containing a bioresorbable, controlled-release,formulation of the nonsteroidal antiandrogen 2-hydroxyflutamide
Other Name: Liproca® Depot Injection

Experimental: Stage II: Dose = 20mL
Subject will be randomized into a group receiving one dose of 2-hydroxyflutamide depot (Liproca® Depot) equal to 20mL
Drug: 2-Hydroxyflutamide Depot
Liproca® Depot is a depot formulation containing a bioresorbable, controlled-release,formulation of the nonsteroidal antiandrogen 2-hydroxyflutamide
Other Name: Liproca® Depot Injection




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Liproca Depot Effect on Prostate Specific Antigen Levels [ Time Frame: 24 weeks ]
    To determine the absolute level and % decrease of PSA level at Week 8, 16, 20 and 24, and PSA nadir.

  2. Liproca Depot Effect on Prostate Volume [ Time Frame: 20 weeks ]
    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.

  3. Evaluation of Lesions [ Time Frame: 20 weeks ]
    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.

  4. Quality of Life (QoL) Questionnaire Score [ Time Frame: 24 weeks ]
    Assessment of QoL Questionnaire scores at Baseline, Week 8,16,20 and 24 after treatment with one of four doses of Liproca Depot.

  5. Micturition Status using the International Prostate Symptom Score (I-PSS) [ Time Frame: 24 weeks ]
    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.

  6. Frequency of Adverse Events [ Time Frame: 24 weeks ]
    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.

  7. Change in Testosterone Levels [ Time Frame: 24 weeks ]
    Testosterone levels (nmol/L) will be assessed at Baseline, Week 8 and 24 after treatment with one of four doses of Liproca Depot.

  8. Systematic Exposure of 2-hydroxyflutamide [ Time Frame: 24 weeks ]
    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.

  9. Pharmacokinetics of 2-hydroxyflutamide [ Time Frame: 24 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348527


Contacts
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Contact: Nada Dragicevic 905-338-1078 ext 225 ndragicevic@cmxres.com
Contact: Nadine Black 905-338-1078 ext 229 nblack@cmxres.com

Locations
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Canada, Nova Scotia
Nova Scotia Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Noreen Miller    905-473-5876    noreen.miller@nshealth.ca   
Principal Investigator: Ricardo Rendon, MD         
Canada, Ontario
Jonathan Giddens Medicine Professional Corporation Recruiting
Brampton, Ontario, Canada, L6T 4S5
Contact: Sangeeta Madaan    905-874-0092    sangeetamadaan@gmail.com   
Principal Investigator: Jonathan Giddens, MD         
G. Kenneth Jansz Medicine Professional Corporation Recruiting
Burlington, Ontario, Canada, L7N 3V2
Contact: Zena Al-Mudaris    905-681-9149    janszresearch@gmail.com   
Principal Investigator: G. Kenneth Jansz, MD         
The Fe/Male Health Centres Recruiting
Oakville, Ontario, Canada, L6H 3 P1
Contact: Rupi Dhaliwal    905-338-3130 ext 2    rdhaliwal@malehealth.com   
Principal Investigator: Peter Incze, MD         
Sub-Investigator: Richard Casey, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Marlene Kebabdjian    416-480-4600 ext 2890    marlene.kebabdjian@sunnybrook.ca   
Principal Investigator: Laurence Klotz, MD         
Canada, Quebec
CIUSSS de l'Estrie - CHUS Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Elsie Morneau    819-346-1110 ext 12827    emorneau.chus@ssss.gouv.qc.ca   
Principal Investigator: Patrick Richard, MD         
Finland
Helsinki University Hospital Recruiting
Helsinki, Finland, FIN-00100
Contact: Antti Rannikko, MD       antti.rannikko@hus.fi   
Principal Investigator: Antti Rannikko, MD         
Tampere University Hospital Recruiting
Tampere, Finland, FI-33521
Contact: Maria Pekki    358 (0)3 3116 6829    maria.pekki@pshp.fi   
Principal Investigator: Teuvo Tammela, MD         
Lithuania
Hospital of Lithuanian University of Health Sciences Recruiting
Kaunas, Lithuania, 50161
Contact: Kestutis Vaiciunas    370 610 31163    kvaic@yahoo.co.uk   
Principal Investigator: Mindaugas Jievaltas, MD         
National Cancer Institute - Oncourology Department Recruiting
Vilnius, Lithuania, 08660
Contact: Donatas Slaitas, MD    370 603 62200    donates.slaitas@gmail.com   
Principal Investigator: Albertas Ulys, MD         
Sponsors and Collaborators
Lidds AB
CMX Research
Investigators
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Study Director: Richard Casey, MD CMX Research
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Responsible Party: Lidds AB
ClinicalTrials.gov Identifier: NCT03348527    
Other Study ID Numbers: LPC-004
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Hydroxyflutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs