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Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Urologic Neoplasms

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Trial Information

Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer


Inclusion Criteria:

Patients: Who are 18 years of age and older Who have histologically
documented adenocarcinoma of prostate Who are currently receiving LHRH agonists KPS
greater than 80%Life expectancy greater than 6 months Provide written consent pursuant to
regulatory requirements prior to initiation of study procedure

Exclusion Criteria:Exclusion Criteria: Patients: Any patient requiring continuous LHRH Any
patient who has had an orchiectomy Any patient with painful bone metastases Who have
received chemotherapy for prostate cancer Who have a abnormal serum creatine >2.5
Receiving any investigational drug within the last 28 days Severe uncontrolled infection,
diabetes, cardiac disease Patients with fragility fractures, hyperparathyroidism, Pagets
renal osteodystrophy will be excluded History of non compliance to medical regimens or
unwillingness to return for medical visits

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently.

Principal Investigator

Dr. Sandy Srinivas

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

PROS0001

NCT ID:

NCT00226954

Start Date:

March 2003

Completion Date:

February 2009

Related Keywords:

  • Urologic Neoplasms
  • Neoplasms
  • Prostatic Neoplasms
  • Urologic Neoplasms

Name

Location

Stanford University School of Medicine Stanford, California  94305-5317