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

This study is currently recruiting participants.
Verified May 2013 by Dana-Farber Cancer Institute
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00116142
First received: June 27, 2005
Last updated: May 17, 2013
Last verified: May 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 2019
Estimated Primary Completion Date: June 2013 (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

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 617-732-8821
Contact: Marian J Loffredo, RN,BS,OCN 617-355-7264

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    617-732-7264      
Contact: Anthony V. D'Amico, MD, PHD    617-732-8821      
Principal Investigator: Anthony V. D'Amico, MD, PHD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Sanofi
Investigators
Principal Investigator: Anthony V. D'Amico, MD, PhD Dana-Farber Cancer Institute
  More Information

No publications provided by Dana-Farber Cancer Institute

Additional 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
Study First Received: June 27, 2005
Last Updated: May 17, 2013
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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Docetaxel
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014