A Double-blind, Placebo-controlled Study to Evaluate New or Worsening Lens Opacifications in Subjects with Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss due to Androgen-Deprivation Therapy

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2012/08/002905
• Date of registration: 23-08-2012
• Prospective Registration: No
• Primary sponsor: Amgen Technology Pvt Ltd
• Public title: A Double-blind, Placebo-controlled Study to Evaluate New or Worsening Lens Opacifications in Subjects with Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss due to Androgen-Deprivation Therapy
• Scientific title: A Double-blind, Placebo-controlled Study to Evaluate New or Worsening Lens Opacifications in Subjects with Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss due to Androgen-Deprivation Therapy
• Date of first enrolment: 16-08-2012
• Target sample size: 760
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=5024
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ireland, Israel, Italy, Latvia, Lithuania, Luxembourg, Malta, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom, United States of America

Contacts

• Name: Dr Veena Jaguste
• Affiliation: Amgen Technology Pvt. Ltd

• Name: Sagar Patil
• Affiliation: Amgen Technology Pvt. Ltd

Key inclusion & exclusion criteria

Inclusion criteria: Men more than 30 years of age with non-metastatic prostate cancer

Have undergone bilateral orchiectomy or initiated ADT with GnRH agonists and is expected to continue on ADT for at least 12 months

ECOG score (0,1 or 2)

Baseline BCVA of 20/40, (6/12 or 0.5 on the decimal scale) or better using the ETDRS charts at 4 meters in one eye with a natural, intact lens

Bone Mineral Density (BMD) requirements:

If 70 years: BMD T-score at the lumbar spine, total hip, or femoral neck 2.5 and 1.0 (osteopenia) If 70 years of age: BMD T-score at lumbar spine and total hip and femoral neck -2.5 At least 2 evaluable lumbar vertebrae




Exclusion criteria: Screening LOCS III grade of 3.5 for posterior subcapsular cataract, 4.0 for cortical cataract, or 4.5 for nuclear opalescence

Bone Mineral Density (BMD) T-score -2.5 at lumbar spine andor total hip andor femoral neck (osteoporosis)

evidence of distant metastases

Known osteonecrosis of the jaw (ONJ)

Unstable system disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization

Incisional eye surgery in both eyes or cataract surgery in both eyes

Current administration of IV bisphosphonates

PSA 5ngmL at screening

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Cancer Cataract Low Bone Mineral Density Osteopenia Osteoporosis Prostate Cancer Health Condition 2: C61- Malignant neoplasm of prostate

Intervention(s)

Intervention1: Active Comparator: Arm A
Denosumab 60 mg subcutaneously on Day 1 and Month 6: Biological: Denosumab
Denosumab 60 mg is administered subcutaneously on Day 1 and Month 6.
Control Intervention1: Placebo Comparator: Arm B
Placebo subcutaneously on Day 1 and Month 6.: Biological: Placebo
Placebo administered subcutaneously on Day 1 and Month 6.

Primary Outcome(s)

Subject incidence of lens opacification event development or progression by month 12, based on a change of â?¥ 1.0 in P, â?¥ 1.0 in C, or â?¥ 0.7 in NO in the LOCS III score.Timepoint: Subject incidence of lens opacification event development or progression by month 12 exceeding a predefined level at any of 3 key lens locations using LOCS III score.

Secondary Outcome(s)

Subject incidence of lens opacification event development or progression by month 6, based on a change of â?¥ 1.0 in P, â?¥ 1.0 in C, or â?¥ 0.7 in NO in the LOCS III scoreTimepoint: [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Adverse event incidence and changes in safety analytes.Timepoint: [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary ID(s)

NCT00925600

20080560 - Protocol amendment 3 dated 25 June 2013

Source(s) of Monetary Support

Amgen Inc

Ethics review

Status: Approved
Approval date: 06/03/2012
Contact:

Sai Urology Hospital Ethics Committee - Dr Abhay

Status: Approved
Approval date: 19/03/2012
Contact:

Christian Medical College and Hospital, Ludiana - Institutional ethics committee

Status: Approved
Approval date: 25/03/2012
Contact:

Manavata Clinical Research institute Professional Ethics Committee

Status: Approved
Approval date: 05/08/2014
Contact:

HCG - Central Ethics committee, HCG-Bangalore Institute of Oncology