Radiation Therapy and Docetaxel in Treating Patients Who Are Undergoing Surgery for Localized Prostate Cancer

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given together with radiation therapy and to see how well they work in treating patients who are undergoing surgery for high-risk localized prostate cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Treatments: Docetaxel

Criteria

INCLUSION CRITERIA; DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Localized disease, meeting 1 of the following staging criteria:

• Clinical stage T2b (palpable bilateral movement) disease

• Surgically resectable T3 disease

• Meets any of the following high-risk* features:

• PSA ≥ 15 ng/mL

• Gleason grade ≥ 4+3 (4+3, 4+4, or 5+any, but not 3+4) NOTE: *High risk defined as > 50% chance of failure with local therapy

• Plans to undergo prostatectomy as primary therapy

• No evidence of lymph nodes ≥ 2 cm in diameter by pelvic CT scan

• Scan only required in patients with a PSA ≥ 40 ng/mL

• No evidence of bone metastases by bone scan

PATIENT CHARACTERISTICS:

• Life expectancy ≥ 10 years

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• White blood cell (WBC) > 3,000/mm^3

• Neutrophil count > 1,500/mm^3

• Platelet count > 100,000/mm^3

• Direct bilirubin normal

• Alanine aminotransferase (ALT) < 2.0 times upper limit of normal (ULN) (1.5 times ULN if alkaline phosphatase [AP] > 2.5 times ULN)

• Alkaline phosphatase (AP) < 4.0 times ULN

• No other serious medical condition that would preclude study treatment

• No other malignancy within the past 5 years except nonmelanoma skin cancer

• No peripheral neuropathy ≥ grade 2

• No hypersensitivity to drugs formulated with polysorbate 80

• No significant contraindications to corticosteroids

• No history of scleroderma

• No active inflammatory bowel disease (IBD) or IBD that is being medically treated

• Inclusion of patients with a remote history of IBD is at the discretion of radiotherapist

EXCLUSION CRITERIA; PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior therapy for prostate cancer, including any of the following:

• Conventional hormonal therapy (e.g., orchiectomy, luteinizing hormone-releasing hormone therapy, antiandrogen therapy, or estrogen therapy)

• External-beam radiotherapy or brachytherapy

• Cryotherapy

• Cytotoxic chemotherapy

• No prior pelvic radiotherapy