Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability and Efficacy of a Liproca® Depot Injection in Patients With Prostate Cancer
Lead Sponsor:
Lidds AB
Collaborating Sponsors:
CMX Research
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
PHASE2
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,Assigne...
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03348527
Start Date
May 12 2017
End Date
November 30 2020
Last Update
December 21 2020
Active Locations (10)
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1
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 2Y9
2
Jonathan Giddens Medicine Professional Corporation
Brampton, Ontario, Canada, L6T 4S5
3
G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, Canada, L7N 3V2
4
The Fe/Male Health Centres
Oakville, Ontario, Canada, L6H 3 P1