A 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 1

• Conditions: Androgen-dependent non-metastatic prostate cancer and therapy-induced bone loss; MedDRA version: 16.1Level: PTClassification code 10065687Term: Bone lossSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 16.1Level: LLTClassification code 10036910Term: Prostate cancer NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-012076-26-BG
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-11
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 760

Inclusion Criteria

Men = 30 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)

Screening 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”; at least one site required).
• If = 70 years: BMD T-score at lumbar spine and total hip and femoral neck = -2.5
• At least 2 evaluable lumbar vertebrae

Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 133
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 627

Exclusion Criteria

Screening LOCS III grade in both eyes of = 3.5 for P, = 4.0 for C, or = 4.5 for NO

Bone Mineral Density (BMD) T-score < -2.5 at lumbar spine and/or total hip and/or femoral neck (osteoporosis”)

Known history of prior fragility fracture (fractures associated with no or minimal trauma severity [eg, fall from standing height])

Evidence of distant metastases

Diagnosis of any secondary non-prostate malignancy within 5 years of randomization, except for adequately treated basal cell or squamous cell skin cancer

Known HIV, HCV, or Hepatitis B Infection

Known osteonecrosis of the jaw (ONJ)

Current hyper-or hypothyroidism (stable on thyroid replacement therapy is allowed, if the TSH is within the normal range)

Paget’s disease, Cushing’s disease, hyperprolactinemia, chronic liver disease or rheumatoid arthritis

Dialysis or expected to undergo dialysis within 1 year

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

Major surgery, or significant traumatic injury occurring within 4 weeks before randomization

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

Ocular disease leading to visual loss (eg, macular degeneration, glaucoma, corneal disease) that would make assessment of visual status difficult.

Planned cataract surgery or major visual disturbance expected to result in need for cataract surgery within one year

Concurrent systemic anti-neoplastic therapy or radiotherapy, other than ADT and/or anti-androgen therapy

Current administration of IV bisphosphonates (oral bisphosphonates allowable if they are stopped at study entry)

Concurrent use of anti-glaucoma medications

Concurrent chronic corticosteroid therapy or pulse corticosteroid therapy including ophthalmologic steroid use (topical, inhaled, or nasal steroids are allowed)

Maximal pupil dilation size <6.0 mm

Prior administration of denosumab

PSA > 5 ng/mL at screening

Serum calcium or albumin-adjusted serum calcium levels < 2.0 mmol/L (8.0 mg/dL), or = 2.9 mmol/L (11.5 mg/dL)

25-hydroxyvitamin D deficiency (< 20 ng/mL)

Is currently enrolled in the active treatment phase of a study investigating an unapproved product or device, or has been treated within the last 30 days with an unapproved product or device. Subjects in the observational phase of clinical studies (eg, to collect survival data) are allowed

Organic or psychiatric disorder which, in the opinion of the investigator may prevent the subject from completing the study or interfere with the interpretation of the study results

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified