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

January 6, 2022 updated by: Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm1: Androgen Suppression Therapy + Radiation Therapy
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: Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Docetaxel plus 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
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 Names:
  • Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10-Year Restricted Mean Survival Time for Overall Survival
Time Frame: Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.
Overall survival (OS) was measured from the date of random assignment to death from any cause, censored at the date of last follow-up in surviving patients. The 10-Year Restricted Mean Survival Time was calculated as the area under the Kaplan Meier plot for OS, from randomization to 10-years follow-up
Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10-year Biochemical Recurrence (PSA Failure)
Time Frame: PSA was measured following the end of RT, then every 6 months for 5 years and annually thereafter, 10 years

Time to biochemical recurrence was defined as the time from date of random assignment to the earliest of PSA failure or initiation of salvage therapy, or censored at the date of last disease assessment for those without PSA failure. PSA failure was defined according to the 2006 RTOG-ASTRO Phoenix definition (i.e., A PSA rise by 2 ng/mL or more above the nadir).

10-year biochemical recurrence rate was estimated from a competing risk model where non-prostate cancer death was counted as competing risk.
PSA was measured following the end of RT, then every 6 months for 5 years and annually thereafter, 10 years
10-year Prostate Cancer Mortality
Time Frame: Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.
Measured from the date of random assignment to date of death from prostate cancer, or censored at the date of last follow-up in surviving patients. Patients who died due to other reasons were counted as competing risk in a competing risk model.
Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.
Number of Participants With Acute Adverse Events
Time Frame: During study treatment or within 30 days of the last dose of study, up to 7.2 months from randomization
Adverse acute events were reported via the clinical database only for toxicities considered reportable via the SAE mechanism (those of grade 2 and grade 3 events that are unexpected and possibly, probably, or definitely related/associated with treatment; or all grade 4 and grade 5 events). Common Toxicity Criteria Volume 3.0 (CTCAE) is used for this study.
During study treatment or within 30 days of the last dose of study, up to 7.2 months from randomization
Number of Participants With Late Adverse Events, Any Grade and Attribution
Time Frame: Every 6 months post radiation therapy for 5 years (+/-90 days), then annually, up to 13.9 years from randomization
Late adverse events will be focused on GU/GI including Urinary/Fecal Incontinence, Hematuria, Diarrhea, Rectal Bleeding and other.
Every 6 months post radiation therapy for 5 years (+/-90 days), then annually, up to 13.9 years from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Sanofi

Investigators

  • Principal Investigator: Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

June 29, 2020

Study Completion (Actual)

June 29, 2020

Study Registration Dates

First Submitted

June 27, 2005

First Submitted That Met QC Criteria

June 27, 2005

First Posted (Estimate)

June 28, 2005

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 6, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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