Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer

Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving hormone therapy and radiation therapy together with chemotherapy is more effective than giving hormone therapy together with radiation therapy in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying hormone therapy and radiation therapy followed by docetaxel and prednisone to see how well it works compared to hormone therapy and radiation therapy in treating patients with localized prostate cancer.

Conditions

• Prostate Cancer

Interventions

DRUG

Dexamethasone

Premedication of dexamethasone prior to docetaxel, per institutional standards.

DRUG

Prednisone

10 mg orally per day until day 21 of the last cycle of docetaxel, beginning 28 days after the completion of RT.

DRUG

docetaxel

75 mg/m2 i.v. over 1 hour (on day 1 of each cycle) every 21 days for 6 cycles, beginning 28 days after the completion of RT.

DRUG

Oral antiandrogen

Oral antiandrogen of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy. Treatment is discontinued at the end of radiation therapy.

RADIATION

Radiation therapy

46.8 Gy, using either three-dimensional conformal radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT), will be given to the regional lymphatics followed by a 25.2-28.8 Gy boost to the prostate, to bring the total dose to the prostate to 72.0-75.6 Gy. Daily prescription doses will be 1.8 Gy per day, 5 days per week x 8-8.5 weeks, beginning 8 weeks after the initiation of androgen suppression.

DRUG

LHRH agonist

LHRH agonist of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy, and then until 24 months from initiation of any treatment has been reached.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• NRG Oncology

  collaborator OTHER

• Radiation Therapy Oncology Group

  lead NETWORK

Principal Investigators

• Howard M. Sandler, MD · University of Michigan Rogel Cancer Center

• Seth Rosenthal, MD · Radiological Associates of Sacramento Medical Group at Sutter Cancer Center

• Mahul Amin, MD · Cedars-Sinai Medical Center

• Leonard G. Gomella, MD · Sidney Kimmel Cancer Center at Thomas Jefferson University

• James Purdy, PhD · University of California, Davis

• Jeff Michalski, MD · Washington University School of Medicine

• Mark Garzotto, MD · Portland VA Medical Center

• Oliver Sartor, MD · Tulane School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-12-31

Primary Completion

2014-04-30

Completion

2022-05-20

Countries

• United States
• Canada

Study Locations