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

NCT03348527 | Completed Phase 2 DMC

• 1 other identifier: LPC-004
• Study Type: interventional
• Target: 61
• Locations: 3 countries
• Sites: 10

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))

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Highest Tolerable Dose of Liproca Depot

  To define the highest tolerable dose of Liproca Depot for transrectal injection into the prostate.

  24 weeks

Secondary Outcomes (9)

• Liproca Depot Effect on Prostate Specific Antigen Levels

  24 weeks

• Liproca Depot Effect on Prostate Volume

  20 weeks

• Evaluation of Lesions

  20 weeks

• Quality of Life (QoL) Questionnaire Score

  24 weeks

• Micturition Status using the International Prostate Symptom Score (I-PSS)

  24 weeks

Study Arms (4)

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.

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.

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

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

Drug: 2-Hydroxyflutamide Depot

Interventions

2-Hydroxyflutamide Depot DRUG

Liproca® Depot is a depot formulation containing a bioresorbable, controlled-release,formulation of the nonsteroidal antiandrogen 2-hydroxyflutamide

Also known as: Liproca® Depot Injection

Stage I: Dose = 35% of prostate volume; Stage I: Dose = 45% of prostate volume; Stage II: Dose = 16mL; Stage II: Dose = 20mL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to any study specific procedures being performed
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lidds AB: lead
• CMX Research: collaborator

Study Sites (10)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Jonathan Giddens Medicine Professional Corporation

Brampton, Ontario, L6T 4S5, Canada

Location

G. Kenneth Jansz Medicine Professional Corporation

Burlington, Ontario, L7N 3V2, Canada

Location

The Fe/Male Health Centres

Oakville, Ontario, L6H 3 P1, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Helsinki University Hospital

Helsinki, FIN-00100, Finland

Location

Tampere University Hospital

Tampere, FI-33521, Finland

Location

Hospital of Lithuanian University of Health Sciences

Kaunas, 50161, Lithuania

Location

National Cancer Institute - Oncourology Department

Vilnius, 08660, Lithuania

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Richard Casey, MD

  CMX Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 21, 2017
• Study Start: May 12, 2017
• Primary Completion: October 30, 2020
• Study Completion: November 30, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

FI (2); LI (2); CA (6)