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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


Phase 3
30 Years
N/A
Open (Enrolling)
Male
Cancer, Cataract, Low Bone Mineral Density, Osteopenia, Osteoporosis, Prostate Cancer

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Trial Information

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


Inclusion Criteria:



- Men >=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 and/or total hip and/or
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 > 5ng/mL at screening.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Subject incidence of cataract event development or progression by month 12 exceeding a predefined level at any of 3 key lens locations using LOCS III score.

Outcome Time Frame:

one year

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Czech Republic: Statni ustav pro kontrolu leciv

Study ID:

20080560

NCT ID:

NCT00925600

Start Date:

November 2009

Completion Date:

July 2015

Related Keywords:

  • Cancer
  • Cataract
  • Low Bone Mineral Density
  • Osteopenia
  • Osteoporosis
  • Prostate Cancer
  • Lens Opacification
  • Bone Loss
  • Androgen Deprivation Therapy
  • Non-metastatic prostate cancer
  • Bone Diseases, Metabolic
  • Osteoporosis
  • Prostatic Neoplasms
  • Cataract

Name

Location

Research Site Anaheim, California  
Research Site Boulder, Colorado  
Research Site Danbury, Connecticut  
Research Site Boca Raton, Florida  
Research Site Boise, Idaho  
Research Site Bloomington, Indiana  
Research Site Ames, Iowa  
Research Site Hays, Kansas  
Research Site Baton Rouge, Louisiana  
Research Site Baltimore, Maryland  
Research Site Battle Kreek, Michigan  
Research Site Alexandria, Minnesota  
Research Site Branson, Missouri  
Research Site Billings, Montana  
Research Site Grand Island, Nebraska  
Research Site Belleville, New Jersey  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Akron, Ohio  
Research Site Allentown, Pennsylvania  
Research Site Charleston, South Carolina  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas  
Research Site Abington, Virginia