Prostate Cancer Clinical Trial
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)).
Verified date | December 2020 |
Source | Lidds AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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))
Status | Completed |
Enrollment | 61 |
Est. completion date | November 30, 2020 |
Est. primary completion date | October 30, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Jonathan Giddens Medicine Professional Corporation | Brampton | Ontario |
Canada | G. Kenneth Jansz Medicine Professional Corporation | Burlington | Ontario |
Canada | Nova Scotia Health Authority | Halifax | Nova Scotia |
Canada | The Fe/Male Health Centres | Oakville | Ontario |
Canada | CIUSSS de l'Estrie - CHUS | Sherbrooke | Quebec |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Finland | Helsinki University Hospital | Helsinki | |
Finland | Tampere University Hospital | Tampere | |
Lithuania | Hospital of Lithuanian University of Health Sciences | Kaunas | |
Lithuania | National Cancer Institute - Oncourology Department | Vilnius |
Lead Sponsor | Collaborator |
---|---|
Lidds AB | CMX Research |
Canada, Finland, Lithuania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Highest Tolerable Dose of Liproca Depot | To define the highest tolerable dose of Liproca Depot for transrectal injection into the prostate. | 24 weeks | |
Secondary | 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. | 24 weeks | |
Secondary | 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. | 20 weeks | |
Secondary | 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. | 20 weeks | |
Secondary | 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. | 24 weeks | |
Secondary | 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. | 24 weeks | |
Secondary | 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. | 24 weeks | |
Secondary | 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. | 24 weeks | |
Secondary | 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. | 24 weeks | |
Secondary | 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. | 24 weeks |
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