EA8191: INDICATE

Clinical Trial Title

EA8191: Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients with Post-ProstaTEctomy Biochemical Recurrence (INDICATE)

National Clinical Trial Number:

NCT04423211

Contact Information

Rush Cancer Center Clinical Trials Office

Clinical Trial Protocol Description:

This phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen [PSA] after surgical removal of the prostate cancer).

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Are male and >= 18 years of age.
  • Have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma.
  • Are a candidate for SOC post-prostatectomy radiation therapy (RT) to the prostate bed and pelvic nodes with androgen deprivation therapy (ADT).

You will be excluded from the study if any of the following criteria apply to you:

  • Have a history of inflammatory bowel disease or any gastrointestinal disorder affecting absorption that is expected to increase risk of complication from radiotherapy.
  • Have not completed a course of prior pelvic radiation therapy for any reason.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Dian Wang, MD

Contact Information

Rush Cancer Center Clinical Trials Office

Clinical Trial Location

Rush University Medical Center

Location

Rush University Medical Center

1620 W Harrison St
Chicago, IL 60612

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