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ECOG-ACRIN EA8191

Trial

Clinical Trial Title

Phase III Study of Local or Systemic Therapy Intensification Directed in Prostate Cancer Patients with Post-ProstaTectomy Biochemical Recurrence (INDICATE)

Trial Status

Open to Enrollment

Start Date

July 15, 2021

Location

Trial Type

Cancer - Adult Oncology

Specific Condition

Prostate Cancer

Description

This phase III trial compares the addition of apalutamide, with or without targeted radiation therapy, to standard of care treatment versus standard of care treatment alone in patients with prostate cancer biochemical recurrence (a rise in the blood level of prostate-specific antigen [PSA] after treatment with surgery or radiation). Diagnostic procedures, such as positron emission tomography/computed tomography (PET/CT), may help doctors look for cancer that has spread to the pelvis. Androgens can cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. This trial may help doctors determine if using PET/CT results to deliver more tailored treatment (i.e., adding apalutamide, with or without targeted radiation therapy, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.

Eligibility Criteria

Registration Eligibility Criteria

  • Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma.
  • Patient must have biochemical recurrence (BCR) after RP, with rising PSA
  • Patient must be negative or equivocal for extrapelvic metastatic disease by conventional imaging modalities (CIM) (anatomic imaging with CT and/or MRI and bone scintigraphy, or equivalent
  • Patient must be a candidate for SOC post-prostatectomy radiation therapy (RT) to the prostate bed and pelvic nodes with androgen deprivation therapy (adjuvant).
  • Patient must have an ECOG performance status 0-2.
  • Patient must not have started androgen deprivation therapy for biochemical recurrence prior to baseline study PET/CT imaging.
  • Patient must not be enrolled in another therapeutic clinical trial.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Principal Investigator Name

Onyekachi Ogbonna, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Wednesday, September 22, 2021 08:50:38 AM