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

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.

Conditions

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

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo 3D CRT

DRUG

Apalutamide

Given PO

PROCEDURE

Computed Tomography

Undergo PET/CT

DRUG

Degarelix

Given SC

RADIATION

External Beam Radiation Therapy

Undergo EBRT

OTHER

Fluciclovine F18

Given IV

DRUG

Goserelin Acetate

Given SC

PROCEDURE

Intensity-Modulated Proton Therapy

Undergo IMPT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

DRUG

Leuprolide Acetate

Given IM

PROCEDURE

Magnetic Resonance Imaging

Undergo PET/MR

PROCEDURE

Positron Emission Tomography

Undergo PET/CT or PET/MR

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Relugolix

Given PO

RADIATION

Stereotactic Body Radiation Therapy

Undergo SBRT

DRUG

Triptorelin

Given IM

RADIATION

Volume Modulated Arc Therapy

Undergo VMAT

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• ECOG-ACRIN Cancer Research Group

  lead NETWORK

Principal Investigators

• Neha Vapiwala · ECOG-ACRIN Cancer Research Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-08

Primary Completion

2032-12-31

Completion

2032-12-31

FDA Drug

Yes

Countries

• United States

Study Locations