RecruitingPhase 3NCT04423211

Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging

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

Enrollment

804 participants

Start Date

Oct 8, 2020

Study Type

INTERVENTIONAL

Conditions

Metastatic Prostate Carcinoma Stage IVB Prostate Cancer AJCC v8 Biochemically Recurrent Prostate Carcinoma Prostate Adenocarcinoma

Summary

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether using a drug called apalutamide (a hormone-blocking pill) combined with targeted radiation — guided by an advanced PET scan that can detect even tiny amounts of prostate cancer — can better treat prostate cancer that has come back after surgery (called biochemical recurrence). **You may be eligible if...** - You are male and 18 or older - You have had your prostate removed (radical prostatectomy) for prostate cancer - Your PSA (a blood marker for prostate cancer) has risen after surgery, indicating the cancer may be returning - A conventional scan (CT or MRI plus bone scan) shows no evidence of spread beyond the pelvis **You may NOT be eligible if...** - Your cancer has clearly spread to distant sites beyond the pelvis on imaging - You have had prior radiation to the prostate area (salvage radiation) - You do not meet PSA criteria for biochemical recurrence Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATION3-Dimensional Conformal Radiation Therapy

Undergo 3D CRT

DRUGApalutamide

Given PO

PROCEDUREComputed Tomography

Undergo PET/CT

DRUGDegarelix

Given SC

RADIATIONExternal Beam Radiation Therapy

Undergo EBRT

OTHERFluciclovine F18

Given IV

DRUGGoserelin Acetate

Given SC

PROCEDUREIntensity-Modulated Proton Therapy

Undergo IMPT

RADIATIONIntensity-Modulated Radiation Therapy

Undergo IMRT

DRUGLeuprolide Acetate

Given IM

PROCEDUREMagnetic Resonance Imaging

Undergo PET/MR

PROCEDUREPositron Emission Tomography

Undergo PET/CT or PET/MR

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

DRUGRelugolix

Given PO

RADIATIONStereotactic Body Radiation Therapy

Undergo SBRT

DRUGTriptorelin

Given IM

RADIATIONVolume Modulated Arc Therapy

Undergo VMAT