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NRG-GU002

Status:

Recruiting | Phase II-III

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

Interventions:   

  • 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

After completion of radiation therapy, patients are followed up on every 3 months for2 years, then every 6 months for 3 years, then annually.

Key Participation Requirements

Gender:

Male

Age:

19 years and older

Diagnosis:

Adenocarcinoma of the prostate.

Prior therapy:

Patients 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.

Methodist Health System Trial Code:

NRG-GU002 

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!