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NRG-GU006

Status:

Recruiting | Phase II 

Official Title:

A Phase II, Double-Blinded, Placebo-Controlled Randomized Trial of Salvage Radiotherapy With or Without Enhanced Anti-Androgen Therapy With Apalutamide in Recurrent Prostate Cancer.

Study Purpose:

To determine if adding apalutamide, a hormone therapy, to radiation treatment for patients with prostate cancer that was previously treated but is now detected in blood will allow patients to do better and live longer.

Interventions:   

  • Radiation Therapy (high energy x-rays to kill cancer cells)
  • Hormone Therapy: Apalutamide
  • Tissue analysis
  • Arm I: Radiation therapy and Placebo orally daily for 6 months.
  • Arm II: Radiation therapy and apalutamide orally daily for 6 months. 

Key Participation Requirements:

Gender:

Male

Age:

19 years and older

Diagnosis:

Adenocarcinoma of the prostate that was previously treated with surgery to remove the prostate.

Eligibility: 

No other prior therapy beyond removal of the prostate

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-GU006

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!