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An Evaluation of Estramustine, Docetaxel and Zoledronate in Patients With Hormone-Refractory Adenocarcinoma of the Prostate

Phase 2
18 Years
Open (Enrolling)
Hormone-Refractory Prostate Cancer

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Trial Information

An Evaluation of Estramustine, Docetaxel and Zoledronate in Patients With Hormone-Refractory Adenocarcinoma of the Prostate

Hormone refractory prostate cancer refers to advanced disease in which the patient no longer
responds to conventional hormonal treatment. When hormone therapy is no longer successful,
chemotherapy is a treatment option. However, current single-agent treatment has shown to
have limited benefit. In this clinical trail, investigators are evaluating the effectiveness
of Zoledronate(Zometa) combined with Estramustine and Docetaxel (Taxotere) in the treatment
of patients with hormone refractory prostate cancer. Zometa is a bisphosphonate, and may
reduce or delay skeletal complications caused by bone metastases. Estramustine and Taxotere
are chemotherapy drugs that have shown activity in hormone refractory prostate cancer.
Eligible patients will be randomized to receive Estramustine and Docetaxel (Taxotere) in
combination with Zometa or Zometa given alone.

Inclusion Criteria

All patients must have a histologic diagnosis of hormone-refractory adenocarcinoma of the
prostate, and hormone refractory disease must be demonstrated by the appearance of new
lesions on bone or CT scan and/or a rising PSA value. (No evidence of brain metastasis or
untreated spinal cord compression.)

Patients on total androgen suppression therapy must undergo nonsteroidal antiandrogen
withdrawal and demonstrate a rising PSA 4 weeks after withdrawal from flutamide and 6
weeks after withdrawal from bicalutamide.

Patient must not be undergoing current chemotherapy, biologic therapy, other
investigational or alternative anti-cancer directed therapy or radiation therapy.

Prior radiation therapy must have completed more than 4 weeks prior to registration.

Patients may not have received prior taxane-based cytotoxic chemotherapy for hormone
refractory disease.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess and compare the effect of zoledronate and docetaxel/estramustine on markers of bone metabolism in patients with hormone-refractory prostate cancer.

Principal Investigator

David C. Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center


United States: Institutional Review Board

Study ID:

UMCC 2001-051



Start Date:

April 2002

Completion Date:

Related Keywords:

  • Hormone-Refractory Prostate Cancer
  • Zometa
  • Prostate Cancer
  • Metastatic Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



The University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109