Purpose

This phase II trial studies how well radiation therapy with or without apalutamide works in treating patients with stage III-IV prostate cancer. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgen can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may lessen the amount of androgen made by the body. Giving radiation therapy and apalutamide may work better at treating prostate cancer than radiation alone.

Category

IRB Number
20180809HU
NCT Number
NCT03371719
Open to Enrollment
Yes
Sponsor
NRG Oncology -



Study Contact

Local Recruitment Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Local Recruitment Point of Contact
Chethan Ramamurthy
(210) 450-1667
ramamurthyc@uthscsa.edu

Local Recruitment Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Principal Investigator
Chethan Ramamurthy

Regulatory Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Regulatory Point of Contact
Chethan Ramamurthy
(210) 450-1667
ramamurthyc@uthscsa.edu

Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu



Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 2
      Study Type
      Interventional
      Allocation
      Randomized
      Intervention Model
      Parallel Assignment
      Primary Purpose
      Treatment
      Masking
      Double (Participant, Investigator)
      Condition
    1. PSA Progression
    2. Stage III Prostate Adenocarcinoma
    3. Stage IV Prostate Adenocarcinoma
    4. Arm Groups

      ArmDescriptionIntervention
      Placebo Comparator

      Arm 1 (Radiation Therapy + Placebo)

      Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on Day 1 of radiation therapy, patients receive placebo PO QD on Days 1-30. Treatment repeats every 30 days for up to 6 courses (6 months) in the absence of disease progression or unacceptable toxicity.
    5. Other: Placebo

      Given PO

      Other names:

      • placebo therapy
      • PLCB
      • sham therapy

    6. Radiation: External Beam Radiation Therapy

      Undergo external beam radiation therapy

      Other names:

      • Definitive Radiation Therapy
      • EBRT
      • External Beam Radiotherapy
      • External Beam RT
      • external radiation
      • External Radiation Therapy
      • external-beam radiation

    7. Experimental

      Arm 2 (Radiation Therapy + Apalutamide)

      Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on Day 1 of radiation therapy, patients receive apalutamide PO QD on Days 1-30. Treatment repeats every 30 days for up to 6 courses (6 months)in the absence of disease progression or unacceptable toxicity.
    8. Drug: Apalutamide

      Given PO

      Other names:

      • ARN 509
      • ARN-509
      • ARN509
      • JNJ 56021927
      • JNJ-56021927

    9. Radiation: External Beam Radiation Therapy

      Undergo external beam radiation therapy

      Other names:

      • Definitive Radiation Therapy
      • EBRT
      • External Beam Radiotherapy
      • External Beam RT
      • external radiation
      • External Radiation Therapy
      • external-beam radiation