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NCT Number: NCT00099086

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • No prior radiation therapy, chemotherapy, immunotherapy or alternative therapy for prostate cancer. Greater than 4 weeks since any major surgery.
  • Performance status 0-2
  • Must meet criteria for acceptable lab values as outlined in the protocol.
  • Peripheral neuropathy must be greater than or equal to 1
  • 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

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

Treatment and study plan

bicalutamide

Drug

Bicalutamide will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months)

Other names: Casodex

docetaxel

Drug

Docetaxel will be administered weekly during radiotherapy. The docetaxel dose will be escalated as part of the study. Dose levels are: 10mg/m2; 15 mg/m2; 20 mg/m2 and 25 mg/m2

Other names: Taxotere

GnRh analog

Drug

A GnRH analog (goserelin acetate, leuprolide acetate) will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months)

Bicalutamide will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months)

Other names: Zoladex, goserelin acetate, leuprolide acetate, Lupron

Radiotherapy

Radiation

External beam photon radiotherapy utilizing 3-D-conformal or intensity modulated radiotherapy (IMRT) shall be used to deliver 77.4 4 Gy in 43 fractions of 1.8 Gy fractions.

Primary outcomes

  1. Maximum tolerated dose (MTD) of Taxotere with radiation therapy and hormonal therapy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Phase I Trial of Concurrent Taxotere With Radiation Therapy and Hormonal Therapy For Clinically Localized High Risk Prostate Cancer

Important dates

Study start
2007
Primary completion
2011
Study completion
2023
First posted
Dec 9, 2004
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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