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

• Status: Completed
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: Male

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))

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CMX Research; Lidds AB
• Collaborators: CMX Research; Lidds AB
• Treatments: Flutamide; Hydroxyflutamide

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