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

• Status: Completed
• Trial end date: 2020-06-29
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: Sanofi
• Treatments: Androgens; Ascorbic Acid; Docetaxel; Estrogens, Conjugated (USP); Methyltestosterone

Criteria

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.