NRG GU008

NRG GU008 Randomized Phase III Trial Incorporating Abiraterone Acetate with Prednisone and Apalutamide and Advanced Imaging into Salvage Treatment for Patients with Node-Positive Prostate Cancer after Radical Prostatectomy (INNOVATE*)

ClinicalTrials.gov Identifier: NCT #04134260

This trial is part of the National Clinical Trials Network (NCTN) program, which is sponsored by the National Cancer Institute (NCI).

Purpose:

Can we lengthen the time without your prostate cancer spreading by adding two new hormone therapy drugs to the usual combination of hormone therapy and radiation therapy

The purpose of this study is to compare the use of hormone therapy and radiation therapy (usual treatment) to the use of apalutamide and abiraterone acetate with prednisone plus the usual treatment. The addition of apalutamide and abiraterone acetate with prednisone to the usual treatment could stabilize your cancer and prevent it from spreading. approach.  To decide if it is better, the study doctors will be looking to see if the study approach increases the time without prostate cancer spreading compared to the usual approach.

The study drugs, apalutamide and abiraterone acetate with prednisone, are already approved by the FDA for use in prostate cancer.  But, most of the time abiraterone acetate with prednisone is not used until hormone drugs stop working and apalutamide is not used until hormone drugs stop working and after prostate cancer has spread.

*All patients considered for this trial will receive a Fluciclovine F-18 PET scan at trial entry..

Treatment Arms:

  • Arm 1—Standard Care
    The usual hormone drugs for up to 24 months plus the usual radiation therapy for 7-8 weeks
  • Arm 2—Experimental Care
    The usual hormone drugs for up to 24 months, the usual radiation therapy for 7-8 weeks, and the study drugs, apalutamide and abiraterone acetate, for 24 months. Abiraterone acetate must be taken with a steroid called prednisone. Both apalutamide and abiraterone acetate are approved by the FDA for use in prostate cancer that does not respond to hormone therapy.

Follow-Up:

Study assessments for 5 years, then annually.

Partial Eligibility Criteria:

  • Partial Eligibility Criteria
  • Pathologically proven diagnosis of prostate adenocarcinoma.  
  • Any type of prostatectomy is permitted.  
  • Detectable PSA after radical prostatectomy(>0ng/mL).
  • No distant (metastatic) cancer 

For additional information, please contact the Research Nurses:

  • Nona Blauvelt, RN, MSN, AOCN; 610-738-2522
  • Susan Metzger, RN, MSN; 610-738-2515
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