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Biochemically Recurrent Prostate CarcinomaProstate healthMen's healthRadiationDrugProcedurePhase 3

What this study is

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).

A second question tests treatment in patients with biochemical recurrence who show prostate cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET) imaging. In these patients, the benefit of adding metastasis-directed radiation to enhanced therapy (apalutamide in combination with abiraterone + prednisone) is tested.

Diagnostic procedures, such as PET, may help doctors look for cancer that has spread to the pelvis. Androgens are hormones that may cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Metastasis-directed 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 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.

What's being tested

  • 3-Dimensional Conformal Radiation Therapy

    Intervention · RADIATION

    Undergo 3D CRT

  • Apalutamide

    Intervention · DRUG

  • Computed Tomography

    Intervention · PROCEDURE

    Undergo PET/CT

  • Degarelix

    Intervention · DRUG

  • External Beam Radiation Therapy

    Intervention · RADIATION

    Undergo EBRT

  • Fluciclovine F18

    Intervention · OTHER

    Given IV

  • Goserelin Acetate

    Intervention · DRUG

  • Intensity-Modulated Proton Therapy

    Intervention · PROCEDURE

    Undergo IMPT

  • Intensity-Modulated Radiation Therapy

    Intervention · RADIATION

    Undergo IMRT

  • Leuprolide Acetate

    Intervention · DRUG

  • Magnetic Resonance Imaging

    Intervention · PROCEDURE

    Undergo PET/MR

  • Positron Emission Tomography

    Intervention · PROCEDURE

    Undergo PET/CT or PET/MR

  • Quality-of-Life Assessment

    Intervention · OTHER

  • Questionnaire Administration

    Intervention · OTHER

  • Relugolix

    Intervention · DRUG

  • Stereotactic Body Radiation Therapy

    Intervention · RADIATION

    Undergo SBRT

  • Triptorelin

    Intervention · DRUG

  • Volume Modulated Arc Therapy

    Intervention · RADIATION

    Undergo VMAT

Both Apalutamide and Relugolix

Given PO

Both Degarelix and Goserelin Acetate

Given SC

Both Leuprolide Acetate and Triptorelin

Given IM

Both Quality-of-Life Assessment and Questionnaire Administration

Ancillary studies

Study details

Official title
Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)
Sponsor
ECOG-ACRIN Cancer Research Group
Conditions
Biochemically Recurrent Prostate Carcinoma · Metastatic Prostate Carcinoma · Prostate Adenocarcinoma · Stage IVB Prostate Cancer AJCC v8
Enrolling
804 people
Starts
2020-10-08
Est. completion
2032-12-31
Design
Open-label, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗