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NRG-GU002 for Prostate Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to compare the effects of using docetaxel along with the radiation therapy and hormone suppression therapy to using radiation and hormone suppression therapy alone in men with a high chance of prostate cancer coming back after surgically removing the prostate.

What is the Condition Being Studied?

Prostate cancer which has been surgically removed

Who Can Participate in the Study?

Adult men who have prostate cancer and the prostate has been surgically removed:
- are 18 years or older

Age Group
Adults

What is Involved?

If you agree to be in this study you will:
- Be randomly assigned (put into one of two groups by chance like a flip of a coin) and receive either:
Group 1 - continue to receive hormone suppression therapy and will get the usual radiation therapy used for prostate cancer
Group 2 - continue to receive hormone suppression therapy and get the usual radiation therapy used for prostate cancer followed by 6 doses of the chemotherapy drug docetaxel.
- Receive hormone suppression therapy for a total of 6 months
- See your doctors every 3 months for 2 years, then every 6 months for 3 years, and then yearly.

Study Details

Full Title
NRG-GU002: Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation following Radical Prostatectomy with or without Adjuvant Docetaxel
Principal Investigator
Radiation Oncologist
Protocol Number
IRB:PRO00083088
NCT:NCT03070886
Phase
Phase II/III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698