Clinical Trials
Sponsor:
Sponsor Study ID:
Study Title:
Phase III Study of Local or Systemic Therapy Intensification Directed by PET in Prostate Cancer Patients with Post Prostatectomy Biochemical Recurrence (INDICATE)
NCT Number:
NCT04423211
Phase:
III
Protocol Type:
Treatment
Age Group:
Adults
Disease Sites:
Prostate
Study Objectives:
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.
Study Documents
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