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A Prospective Study to Evaluate the Incidence of Skeletal Related Events In Prostate Cancer Patients Undergoing Androgen Deprivation Therapy (ADT).


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

A Prospective Study to Evaluate the Incidence of Skeletal Related Events In Prostate Cancer Patients Undergoing Androgen Deprivation Therapy (ADT).


A consequence of ADT is the gradual bone loss, so-called cancer treatment induced bone loss
(CTIBL). The current standard of care is the addition of Vitamin D and Calcium upon the
initiation of ADT. Moreover, bisphosphonates are now being considered to treat and prevent
CTIBL. However, bisphosphonates are costly, thus there is a desire to identify or target a
specific subset of patients who would most benefit from the treatment.

By obtaining baseline BMD and monitoring for Skeletal Related Events (SREs), we hope to
identify that specific sub-set of patients who would most benefit from the treatment. Using
a prospective, observational study design, we propose monitoring how physicians manage CTIBL
in their patients.


Inclusion Criteria:



- Patients willing to provide written Informed Consent.

- Patients for whom Androgen Deprivation Therapy (ADT) with Zoladex® is indicated for
at least 1 year.

- Patients started on Zoladex® within the last 4 months.

Exclusion Criteria:

- Patient had surgery or significant traumatic injury occurring within 1 month prior to
consent.

- Known hypersensitivity to Goserelin Acetate or any of the components found in
Zoladex®.

- Any concurrent condition that would make it undesirable, in the physician's opinion,
for the subject to participate in the study or would jeopardize compliance with the
protocol.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Bone Mineral Density of the lumbar spine

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Richard W Casey, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

CMX Research

Authority:

Canada: Ethics Review Committee

Study ID:

AZ-CMX-03

NCT ID:

NCT00632905

Start Date:

September 2007

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Prostatic adenoma
  • Prostatic neoplasm
  • Prostatic Neoplasms

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