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

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Bicalutamide; Drug: docetaxel; Drug: GnRh analog; Radiation: radiotherapy

• Registration Number: NCT00099086
• Lead Sponsor: Medical University of South Carolina

Brief 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.

Detailed Description

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. Radiation therapy uses high energy x-rays to kill tumor cells. Docetaxel may also make tumor cells more sensitive to radiation therapy. Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, or bicalutamide, may stop the adrenal glands from making androgens. Giving chemotherapy with radiation therapy and hormone therapy may kill more tumor cells.

Study Timeline

• Study First Submitted: 2004-12-08
• Study First Submitted QC: 2004-12-08
• Study First Posted: 2004-12-09
• Study Start: 2007-01-16
• Primary Completion: 2011-01-20
• Study Completion: 2023-12-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Arm	docetaxel	-
Experimental Arm	GnRh analog	-
Experimental Arm	radiotherapy	-
Experimental Arm	Bicalutamide	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) of Taxotere with radiation therapy and hormonal therapy	57 days	To determine the MTD of Taxotere with radiation therapy and hormonal therapy in patients with high risk locally advanced adenocarcinoma of the prostate. The dose limiting toxicity (CLT) period for determining the MTD is 57 days.