Prostate Cancer Clinical Trial
Official title:
Prevention of Micro-architectural Bone Decay in Males With Non-metastatic Prostate Cancer Receiving Androgen Deprivation Therapy (ADT)
Less than 20% of men in whom prostate cancer is diagnosed early die from it. Cardiovascular
disease is the most common cause of death in men with early prostate cancer. A commonly used
form of treatment for prostate cancer is androgen deprivation therapy (ADT). ADT, while
effective for the treatment of prostate cancer, has been linked to undesirable side effects,
such as an increased risk of bone fractures and diabetes. Bisphosphonates, a class of drugs
that prevent bone resorption, have been show to reduce the loss of bone mineral density that
occurs as a consequence of ADT, but the effects of bisphosphonates on preservation of bone
architecture is unknown.
This project has two main goals:
To assess prospectively, in men with prostate cancer receiving ADT, the effect of:
1. the intravenous bisphosphonate zoledronic acidon ADT-induced microarchitectural decay of
bone structure.
2. ADT on insulin resistance and glucose metabolism. We will recruit 100 ambulatory men
with non-metastatic prostate cancer who are about to commence a three year course of ADT
as per routine clinical practice at Austin Health. Men will be randomised to receive
either intravenous zoledronic acid (Aclasta, Novartis Pharmaceuticals) or placebo at
baseline and after 12 months of ADT. Men with contraindications to zoledronic acid will
be excluded from the study. All 100 study subjects will have clinical and laboratory
assessment at baseline, and at 3, 6, 12, 18 and 24 months (study end), and imaging
studies at baseline and at 6, 12 and 24 months.
The study protocol is outlined in more detail below (Please see flow chart included in the in
PICF):
Clinical and laboratory assessment:
Full medical history, physical examination and quality of life assessment using the SF-36
questionnaire. Laboratory studies will include: oral glucose tolerance test (3, 12 and 24
months Commercial-in-Confidence only) and measurements of measure total testosterone, fasting
glucose, C-peptide, HBA1c, bone turnover markers.
Imaging studies:
1. Bony micro-architecture by high resolution quantitative computed tomography
2. Bone mineral density and body composition by DEXA This project will have no direct
benefit for the subjects involved in this study; however, it will improve our
understanding on the effect of zoledronic acid on bone microarchitecture in men with
prostate cancer receiving ADT. It will also help us to better understand the effect of
ADT on insulin resistance and glucose metabolism.
Not desired ;
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