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NRG GU002

Trial Overview

Official Title

Phase II-III Trial of Adjuvant Radiotherapy Following Radical Prostatectomy With or Without Adjuvant Docetaxel

Study Purpose

To assess the impact Docetaxel has on the survival of patients who received radiation and hormone therapy after prostate removal

Diagnosis

Adenocarcinoma of the prostate.

Eligibility

Must have had their prostate removed within 1 year of enrollment.

Prior hormone therapy is allowed as long as it has been stopped at least 90 days before enrollment.

No other systemic chemotherapy for this cancer is allowed.

Whole gland cryoablative therapy is not allowed.

Patients are not eligible if they have evidence of metastatic cancer or lymph node involvement.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

  • Radiation Therapy 
  • Chemotherapy: Docetaxel    
  • Hormone Therapy: BicalutamideLuteinizing hormone releasing hormone agonist/antagonist 
  • Lab Biomarker and genomic Analysis
  • Arm I: Radiation therapy starting 8 weeks after start of LHRH agonist/antagonist and bicautamide.  Patients will take the LHRH agonist/antagonist and bicautamide for 6 months.
  • Arm II: Radiation therapy starting 8 weeks after start of LHRH agonist/antagonist and bicautamide.  Patients will take the LHRH agonist/antagonist and bicautamide for 6 months.  Patients will receive Docetaxel for 6 cycles with each cycle being 21 days.  This will start 4-6 weeks after completion of radiation.

Will be followed up every 3 months for 2 years, then every 6 months for 3 years, then annually, after completion of radiation therapy.

For more information, visit ClinicalTrials.gov

Key Participation Requirements
Gender
Male
Age
19 years and older
Phase
Phase II
Methodist Health System Trial Code
GU002
Related Specialties