Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer

Summary

RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy plus radiation therapy is more effective with or without combination chemotherapy for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy plus radiation therapy with or without combination chemotherapy in treating patients who have prostate cancer.

Conditions

• Prostate Cancer

Interventions

DRUG

bicalutamide

Administered orally at a dose of one 50mg tablet per day. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy.

DRUG

estramustine phosphate sodium

280 mg three times a day for 14 days and repeated every 3 weeks for 4 cycles

DRUG

etoposide

50 mg/m\^2 in divided doses b.i.d. for 14 days and repeated every 3 weeks for 4 cycles

DRUG

flutamide

Administered orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy.

DRUG

paclitaxel

135 mg/m\^2 given as a 1-hour infusion (on day 2 of each cycle) and repeated every 3 weeks for 4 cycles

DRUG

Luteinizing hormone releasing hormone [LHRH] agonist

Releasing hormone agonists (such as leuprolide, goserelin, buserelin, triptorelin) will be given for 4 months

RADIATION

Radiation therapy

Radiation will begin 8 weeks following the initiation of hormone administration: 46.8 Gy to the regional lymphatics followed by a 23.4 Gy boost to the prostate to bring the total dose to the prostate to 70.2 Gy. Daily tumor doses will be 1.8 Gy per day, 5 days per week x 7-8 weeks.

DRUG

warfarin

To keep international normalized ratio (INR) \> 1.5 and \< 2.5; begins with the start of chemotherapy and will be given continuously until 4 weeks after the end of the fourth cycle of chemotherapy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Radiation Therapy Oncology Group

  lead NETWORK

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-01-31

Primary Completion

2010-04-30

Completion

2013-11-30

Countries

• United States
• Canada

Study Locations