ADAPT 20129218

Study StatusEnrolling
Protocol20129218
SponsorCUSP
Study Description

Race, bone health and the cardio-metabolic consequences of Androgen Deprivation Therapy for Prostate Cancer

Primary Endpoint

- Determine if racial and ethnic differences exist in the bone and cardio-metabolic consequences associated with the receipt of ADT.
- Determine if the bone and metabolic consequences of ADT can be predicted by baseline profile.
- Determine the correlation between serum markers of bone resorption and BMD with the measures related to metabolic syndrome.

Inclusion Criteria

- Subject must be a man age <85 years of age
- Adenocarcinoma of the prostate confirmed histologically or cytologically confirmed.
- Self-identified as African American or Hispanic or Non-hispanic White.
- An indication for at least 12 months of ADT (GNRH agonist/antagonist or orchiectomy)

Exclusion Criteria

- Receipt of ADT or any medically castrating agent at any time point prior to enrollment.
- Use of bisphosphonates, denosumab or selective estrogen receptor modulators (SERMs) at any point in time point prior to enrollment.
- A medical history of osteoporosis or osteopenia with a planned treatment use of either bisphosphonates, denosumab, or SERMs while on study.
- Evidence of metastatic disease (positive lymph nodes are acceptable)
- Baseline DEXA with a T-score of <= -2.5 at any site.

Side Effects

ADT administered as per standard protocol

Interested in enrolling in this trial? Please call 717-431-2285.


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