bicalutamide
DrugBicalutamide will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months)
Other names: Casodex
NCT Number: NCT00099086
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.
Looking for future studies?
Notify Me18 year and older
Male
Interventional
Phase 1
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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
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
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.
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.
Medical University of South Carolina
Other
Phase I Trial of Concurrent Taxotere With Radiation Therapy and Hormonal Therapy For Clinically Localized High Risk Prostate Cancer
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.
Published trials that share one or more normalized conditions with this study.
NCT03269422
Genital Diseases, Genital Diseases, Male
Basking Ridge, New Jersey, United States
View Trial DetailsNCT05754658
Breast Cancer, Breast Diseases
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT03606837
Genital Diseases, Genital Diseases, Male
Bordeaux, France
View Trial DetailsNCT06540794
Genital Diseases, Genital Diseases, Male
Istanbul, Turkey (Türkiye)
View Trial Details