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OpenTrials
Completed

NCT Number: NCT00193271

Adjuvant Docetaxel and Estramustine Phosphate for High Risk Localized Prostate Cancer

This trial will evaluate the feasibility, toxicity, and efficacy of docetaxel/estramustine, as in the adjuvant therapy of patients with high-risk prostate cancer after definitive local therapy.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

About this study

Upon determination of eligibility, patients will receive:

Docetaxel + Estramustine

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To be included in this study, you must meet the following criteria:

  • Histologically confirmed adenocarcinoma of the prostate
  • Clinically or surgically staged localized disease, stage I-III.
  • Prior surgical resection or radiation therapy with curative intent
  • No clinical evidence of residual disease
  • Gleason's combined score > 7.
  • Age > 18 years.
  • No prior chemotherapy for prostate cancer.
  • No previous androgen deprivation therapy for prostate cancer
  • Able to perform activities of daily living with minimal assistance
  • Adequate bone marrow, liver and kidney function
  • Voluntarily provide written informed consent.

Exclusion criteria

You cannot participate in this study if any of the following apply to you:

  • History of prior malignancy in the past five years
  • History of significant heart disease within the previous 6 months
  • Cerebral vascular accident (CVA) or stroke within the previous 6 months.
  • Moderate or severe peripheral neuropathy
  • Previous therapy with other injectable radioisotopes.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Treatment and study plan

docetaxel

Drug

Estramustine

Drug

Primary outcomes

  1. Response Rate

Secondary outcomes

  1. Rate of recurrence

  2. Toxicity

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Aventis Pharmaceuticals

Registry information

Official study title

Adjuvant Chemotherapy (Docetaxel and Estramustine Phosphate) for High Risk Localized Prostate Cancer

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
May 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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