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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


Phase 3
30 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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).


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine if overall survival is increased

Outcome Time Frame:

2014

Safety Issue:

No

Principal Investigator

Anthony V. D'Amico, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

05-043

NCT ID:

NCT00116142

Start Date:

June 2005

Completion Date:

June 2019

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Hormone Refractory
  • Metastatic
  • Localized
  • Locally Advanced
  • Prostate Cancer - High Risk Localized or Locally Advanced
  • Prostatic Neoplasms

Name

Location

Dana-Farber Cancer Institute and (Sanofi-Aventis Consortium)Boston, Massachusetts  02115