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Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00116142
First Posted: June 28, 2005
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute
  Purpose
This randomized study is looking at the benefits of using docetaxel (chemotherapy) added to one of the standard treatments (radiation and hormones) for men with high-risk prostate cancer.

Condition Intervention Phase
Prostate Cancer Drug: Docetaxel Drug: Androgen Hormonal Suppression and Radiation Drug: Androgen Suppression Therapy and Radiation Therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Docetaxel Plus 6-month Androgen Suppression and Radiation Therapy Versus 6-month Androgen Suppression and Radiation Therapy for Patients With High Risk Localized or Locally Advanced Prostate Cancer: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine if overall survival is increased [ Time Frame: 2014 ]

Secondary Outcome Measures:
  • To determine if PSA doubling time is prolonged; To determine if PSA failure is decreased; To determine if cancer specific mortality is decreased [ Time Frame: 2014 ]

Estimated Enrollment: 350
Study Start Date: June 2005
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Androgen Suppression Therapy and Radiation therapy
Drug: Androgen Hormonal Suppression and Radiation
Total Androgen Ablation and external beam radiation therapy
Drug: Androgen Suppression Therapy and Radiation Therapy
Total Androgen Ablation and External Beam Radiation Therapy
Experimental: 2
Docetaxel plus androgen suppression therapy and radiation therapy
Drug: Docetaxel
60 mg/m² q 3 weeks for 3 cycle at the start of treatment followed by weekly Docetaxel at 20 mg/m² per week beginning at week one of radiation therapy and continuing for seven weeks.
Other Name: Taxotere

Detailed Description:
Radiation therapy plus six months of hormone therapy is one standard way of treating men with high-risk prostate cancer. In this study, we want to see whether or not adding the chemotherapy drug docetaxel (Taxotere)will make this treatment more effective. Docetaxel has shown a benefit in median survival when given to men who have become resistant to hormonal therapy and in men who have metastatic prostate cancer (spread to other areas of the body).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven prostate cancer
  • Clinical Tumor Category T1b, T1c, T2a and PSA greater than (>) 10 or Gleason score equal or greater than 4+3=7 or PSA velocity > 2.0 ng/ml per year and also eligible patients with tumor category T2c, T3a, T3b, or T4 as per 2002 AJCC guidelines. Any minor tertiary grade of Gleason 5; Biopsy Proven or Radiographic (erMRI Seminal Vesicle Invasion); Gleason = or > 3+4=7 with 50% or more cores positive
  • Negative bone scan
  • Lymph node assessment by CT or MR
  • Adequate hematologic function (Blood Counts)
  • Adequate liver functions (blood tests)
  • ECOG performance Status 0 or 1
  • Peripheral neuropathy must be =< grade 1
  • PSA obtained within 3 months of entry

Exclusion Criteria:

  • Prior history of malignancy that are < 5 years except for cancers found to be "in-situ" and would not likely impact a patient's life expectancy with appropriate medical management.
  • Prior pelvic radiation therapy
  • Prior hormonal therapy (up to 4 weeks prior to enrollment allowed)
  • Individuals unable to tolerate lying still 5 - 10 minutes
  • Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 90.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116142


Locations
United States, Massachusetts
Dana-Farber Cancer Institute and (Sanofi-Aventis Consortium)
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Sanofi
Investigators
Principal Investigator: Anthony V. D'Amico, MD, PhD Dana-Farber Cancer Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anthony V. D'Amico, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00116142     History of Changes
Other Study ID Numbers: 05-043
First Submitted: June 27, 2005
First Posted: June 28, 2005
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute:
Prostate Cancer
Hormone Refractory
Metastatic
Localized
Locally Advanced
Prostate Cancer - High Risk Localized or Locally Advanced

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Methyltestosterone
Androgens
Ascorbic Acid
Estrogens, Conjugated (USP)
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Protective Agents
Vitamins
Micronutrients
Growth Substances
Estrogens
Antineoplastic Agents, Hormonal
Anabolic Agents