Research - Bone Loss (Prostate Cancer Clinical Trial)

The Urology Team Research Department is currently conducting a clinical research study that offers treatment for Bone Loss in subjects undergoing Androgen-Deprivation Therapy (ADT) for Non-metastatic Prostate Cancer. The goal is to assess the effect of denosumab on cataract event development or progression.

Symptoms:

If you are at least 30 years old, have non-metastatic prostate cancer, have undergone bilateral orchiectomy (testicles removed) or initiated Androgen-Deprivation Therapy (ADT) and are expected to continue on ADT for at least 12 months you may qualify.

Study Design:

This study consists of 10 study visits over the course of a year. You will see the study Urologist for 4 study visits and 6 study visits at the Ophthalmologist. This study is also posted on clinicaltrials.gov. Please use this link below to access the posting for more study details:

http://www.clinicaltrials.gov/ct2/show/NCT00925600?term=amgen+20080560&r...

Study Criteria:

• 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
• Signed informed consent

Exclusion Criteria:

• Screening LOCS III grade 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)
• Incapable of being responsive to midriatic agents (minimum of approximately a 6 mm pupil required)
• 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)
• Not willing to use 2 highly effective methods of contraception during treatment and for 10 months after the end of treatment
• Subject with a pregnant partner who is not willing to use a condom during treatment and for additional 10 months after the end of treatment
• 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

How Can I Find Out If I’m Eligible?

If you or someone you love may be interested in participating and would like to know more about this clinical trial study, please contact our Research Coordinator at 512-901-9466 or e-mail research@urologyteam.com.

Why Should You Participate in a Clinical Trial?

By participating in a clinical trial you may be contributing to the advancement of medicine and helping others. As a clinical trial participant, you would receive study medication, calcium and vitamin D supplements, DXA scan, eye exams and certain other care related to the study at no cost to you for the duration of the trial. You will also receive reimbursement for certain expenses related to travel for study visits. You will only be financially responsible for procedures that are under standard of care for your condition that occur only during clinic visits, which are separate from study visits. These kind of procedures will be billed to you or your insurance as applicable.

Study Site Locations:

This study is being conducted at the following Urology Team locations:

NORTH LOCATION – Arboretum Medical Center
 11410 Jollyville Road
Suite 1101
Austin, Texas 78759
http://www.mapquest.com/maps/map.adp?address=11410_Jollyville_Road&city=...

SOUTH LOCATION – Westlake Medical Center
 5656 Bee Caves Road
Suite D-200
Austin, Texas 78746
http://www.mapquest.com/maps/map.adp?searchtype=address&country=US&addto...

Study Site Ophthalmologist Location:

OPHTHALMOLOGY - NORTH LOCATION ONLY– Austin Diagnostic Clinic
 12221 MoPac Expressway, North
Second Floor, North Entrance
Austin, Texas 78758
http://www.adclinic.com/Doctors_Specialties_Maps/Locations/adcmainclinic...