Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

This phase I trial is studying the side effects and best dose of docetaxel when given with radiation therapy and hormone therapy in patients with locally advanced prostate cancer.

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

Details

• Lead Sponsor: David T. Marshall; Medical University of South Carolina
• Treatments: Bicalutamide; Docetaxel; Goserelin; Leuprolide

Criteria

Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate with one of the prognostic factors specified in the protocol. No pelvic lymph node disease that would necessitate pelvic radiotherapy. No radiologic evidence of metastatic disease on bone scan or on CT scan or MRI of the abdomen or pelvis

2. No prior radiation therapy, chemotherapy, immunotherapy or alternative therapy for prostate cancer. Greater than 4 weeks since any major surgery.

3. Performance status 0-2

4. Must meet criteria for acceptable lab values as outlined in the protocol.

5. Peripheral neuropathy must be greater than or equal to 1

6. Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

Exclusion Criteria:

1. No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80