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

Study Status

Open to Enrollment

Study Description

This is a clinical trial for patients with prostate cancer who are receiving androgen deprivation therapy for the prostate cancer. Treatment of prostate cancer is often initially targeted at removal and/or radiation of the tumor and preventing the spread of tumor cells. Another common treatment is called androgen deprivation therapy (ADT), which is a type of hormone therapy where the body is deprived of androgen that feeds the prostate cancer. However, ADT is also an important cause of osteoporosis (thinning of bones)—loss of bone mass and increased risk of fractures.

Denosumab is a novel protein that has been shown in clinical trials to regulate bone metabolism by inhibiting the cells that break down bone. This results in a slower rate that bone is broken down and an increase in bone mass. In an earlier study denosumab was shown to be well tolerated and to have an overall safety profile similar to the placebo.

However, the number of patients with cataracts (clouding of the lens in the eye) was higher in the group of patients who received denosumab compared to the group of patients who received placebo. Since there was a difference in the number of cataracts compared to placebo, we would like to further study this.

The purpose of this current study is to evaluate if there is a difference between denosumab and placebo in changes in patients’ eyes and the lenses in their eyes. These differences will be evaluated using eye examinations that ophthalmologists use in evaluating changes to the eyes

Study participants will be randomly assigned to 1 of 2 study groups:

  • Group 1: 60 mg of denosumab subcutaneous (under the skin) injection at Day 1 and Month 6
  • Group 2: 60 mg of placebo (looks like denosumab but contains no medicine) injection on Day 1 and Month 6

Neither you nor the study physician will know whether you are receiving denosumab or placebo. Patients will also take daily supplements of Vitamin D and calcium. The expected time on study is about 13 months.

Disease Status and/or Stage

Prostate Cancer Receiving Androgen Deprivation Therapy



Key Eligibility

  • Men age 30 and older with non-metastatic prostate cancer
  • Have undergone bilateral orchiectomy or initiated ADT and expected to continue on ADT for at least 12 months
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Scott Tagawa, MD


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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