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

Sponsors and Collaborators:	Dana-Farber Cancer Institute Sanofi-Aventis
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00116142

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 III

MedlinePlus related topics: Cancer Prostate Cancer Radiation Therapy

Drug Information available for: Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine if overall survival is increased [ Time Frame: 2014 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	350
Study Start Date:	June 2005
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2011 (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
2: Experimental 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.

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

Ages Eligible for Study:	30 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116142

Contacts

Contact: Anthony V D'Amico, MD, PHD	617-732-7936
Contact: Marian J Loffredo, RN,BS,OCN	617-732-7936

Locations

United States, Massachusetts
Dana-Farber Cancer Institute and (Sanofi-Aventis Consortium)	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Marian J. Loffredo, RN, BS, OCN 617-732-7936
Contact: Anthony V. D'Amico, MD, PHD 617-732-7936
Principal Investigator: Anthony V. D'Amico, MD, PHD

Sponsors and Collaborators

Dana-Farber Cancer Institute

Sanofi-Aventis

Investigators

Principal Investigator:

Anthony V. D'Amico, MD, PhD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Brigham and Women's Hospital ( Anthony V. D'Amico )
Study ID Numbers:	05-043
Study First Received:	June 27, 2005
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00116142 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Prostate Cancer
Hormone Refractory
Metastatic

Localized
Locally Advanced
Prostate Cancer - High Risk Localized or Locally Advanced

Study placed in the following topic categories:

Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

Urogenital Neoplasms
Genital Diseases, Male
Hormones
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Hormones

Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms
Androgens

ClinicalTrials.gov processed this record on May 07, 2009