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

Dana-Farber Cancer Institute

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Androgen Hormonal Suppression and Radiation; Drug: Docetaxel; Drug: Androgen Suppression Therapy and Radiation Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00116142

05-043

Details and patient eligibility

About

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.

Full 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).

Enrollment: 350 patients

Sex: Male

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Arm1: Androgen Suppression Therapy + Radiation Therapy

Other group

Description:

Androgen Suppression Therapy and Radiation therapy

Treatment:

Drug: Androgen Suppression Therapy and Radiation Therapy

Drug: Androgen Hormonal Suppression and Radiation

Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy

Experimental group

Description:

Docetaxel plus androgen suppression therapy and radiation therapy

Treatment:

Drug: Docetaxel

Drug: Androgen Suppression Therapy and Radiation Therapy

Drug: Androgen Hormonal Suppression and Radiation