Asymptomatic localized prostate cancer patients
Conditions
Interventions
Product Name: Liproca® Depot
Product Code: Not applicaple
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: 2-HY
Sponsors
LIDDS AB
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Signed informed consent prior to any study specific procedures being performed 2.18 - 80 years of age, inclusive 3.Assigned to Active Surveillance 4.Histologically confirmed, localized prostate cancer within 24 months of Screening 5.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 (ng/mL) and = 20 µg/L (ng/mL) -Any systematic core > 50% involvement -Any PI-RADS 4 or 5 on MRI -Any Gleason grade 4 -Men of African descent 6.Patient has a negative bone scan within the last 12 months 7.Patient is able to have an MRI 8.Prostate volume = 80 mL (measured by MRI within 12 months of Screening or has been scheduled for an MRI prior to Screening) 9.9.eGFR = 30 mL/min, using the Cockcroft – Gault Equation: Creatinine Clearance = [{(140 – age in years) x (weight in kg)} x 1.23] serum Creatinine in micromol/l Link to eGFR calculator https://www.mdcalc.com/creatinine-clearance-cockcroft-gault-equation 10.AST, ALT and ALP = 1.5 times upper limit of normal 11.Patient must be willing to comply with all study procedures 12.Patients must agree to the use of medically acceptable methods of contraception during the entire 24 weeks study period including non-hormonal intrauterine device (IUD) or double barrier method (condom with foam or vaginal spermicidal suppository, diaphragm with spermicide), unless the patient and/or their partner has been surgically sterilized Open Label Extension Study: -Overall safety results are acceptable, as determined by the Investigator and in consult with the Sponsor -Subject has consented to participate in the Open Label Extension Study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1.PSA > 20 µg/L (ng/mL) 2.Previous or ongoing hormonal therapy for prostate cancer 3.Positive urine culture before treatment with prophylactic antibiotics 4.Ongoing or previous therapy with finasteride or dutasteride in the last 3 months 5.Ongoing or previous invasive therapy for benign prostate hyperplasia (BPH) (e.g. TURP, TUMT, HIFU, etc.) 6.Use of pacemaker or other implanted electronic devices 7.Metal implant in the pelvis (e.g. hip replacement) that may affect the MRI of the prostate 8.Allergy to Liproca® Depot and its ingredients 9.Severe micturition symptoms (I-PSS >15 or residual urine volume > 150 mL) confirmed by repeat measurement or Qmax< 12 mL/s 10.Ongoing therapy with the anticoagulant Acetyl Salicylic Acid (ASA) (more than 100 mg/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 11.Use of any previous focal prostate cancer treatment, such as transurethral resection, cryotherapy, high intensity frequency ultrasound (HIFU) and/or photodynamic therapy 12.Concomitant systemic treatment with corticosteroids or immune modulating agents 13.Known immunosuppressive disease (e.g. HIV, Type II Diabetes). Patients with well controlled Type II Diabetes may be included, as determined by Investigator 14.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 15.Infection in WHO Risk Group 2, 3 or 4 (see Appendix A) Open Label Extension Study: Same exclusion criteria as above
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives: •To define the highest tolerable dose of Liproca®Depot for transrectal injection into the prostate •To determine the level of Prostate Specific Antigen (PSA) reduction for the doses in Stage II ; Secondary Objective: Secondary Objectives: •To determine the effect on PSA as a function of time from injection up to 24 weeks after treatment with Liproca® Depot, at four dose levels •To determine the safety and tolerability of a single dose of Liproca® Depot, up to 24 weeks after treatment Open-Label Objectives: •To determine the time to PSA recurrence (defined as a PSA level exceeding at least 100 % of Baseline value) beyond 24 weeks after treatment with Liproca® Depot •To evaluate the safety, tolerability and efficacy of a second treatment of Liproca® Depot 24 weeks after treatment (using the same dose as the initial treatment) ; Primary end point(s): •The highest tolerable dose of Liproca® Depot •Responder rate, absolute levels and % decrease in Prostate Specific Antigen (PSA) 20 weeks after treatment for the doses of Liproca® Depot selected in Stage II. A responder is defined as a patient with a PSA decrease of more than 15%. ;Timepoint(s) of evaluation of this end point: Week 20 (5 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Endpoints: •Responder rates, absolute levels and % decrease of PSA level at Week 8, 16, 20 and 24, and PSA nadir. A responder is defined as a patient with a PSA decrease of more than 15%. •MRI evaluation of prostate volume (PV) measured as % decrease versus Baseline and as absolute values •Evaluation of lesions (PI-RADS score) 20 weeks after treatment •Quality of Life (QoL) assessment at Baseline, Week 8, 16, 20 and 24 after treatment Safety Endpoints •Vital signs, chemistry and haematology data, urinary flow (Qmax), residual urine volume, International Prostate Symptom Score (I-PSS), and adverse events, accumulated over the 14 day period after treatment •Micturition status (I-PSS) at Week 8, 16 and 24 •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 •Testosterone levels at Baseline, Week 8 and 24 after treatment Pharmacokinetics •Pharmacokinetic (PK) levels of 2-hydroxyflutamide at Baseline, Hour 2, Day 2, 4, 7 and 14, Week 8 and at End of Study •Pharmacokinetics will be evaluated in all subjects in Stage I and a subset of subjects in Stage II. Pharmacokinetics will be characterized using standard PK variables such as T1/2, Tmax, Cmax, AUC Open-Label Endpoints: •PSA level at Week 32, 40 or 48, or until PSA recurrence (defined as a PSA level exceeding at least 100 % of Baseline value) •PSA level at 8 Weeks and 24 Weeks after the second treatment with Liproca® Depot •All adverse events (AEs) over the full study period after the second treatment and followed until all being resolved •MRI evaluation (including prostate volume) 24 Weeks after the se | — |
Countries
Canada, Finland, Lithuania
Contacts
Public ContactTiina Kärjä-Lahdensuu
CO Consult Oy
Outcome results
None listed