UAMS - Translational Research Institute

Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer

Purpose

This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.

Conditions

Prostate Adenocarcinoma
Stage III Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: Male
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

- Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma
of prostate cancer

- High-risk disease defined as having at least one or more of the following:

- cT3a-T3b by digital exam or imaging (American Joint Committee on Cancer [AJCC]
8th edition [Ed.]) Note: cT4 by imaging or on digital rectal exam is not
allowed

- The patient's prostate specific antigen (PSA) value > 20 ng/mL prior to
starting androgen deprivation therapy (ADT) Note: Patients taking a 5-alpha
reductase inhibitor (ex finasteride or dutasteride) are eligible The baseline
PSA value should be doubled for PSAs taken while on 5-alpha reductase
inhibitors

- Gleason Score of 8-10

- Pelvic node positive by conventional imaging with a short axis of at least 1.0
cm

- Prostate gland volume less than 100 cc prior to initiation of ADT as reported at
time of biopsy or by separate measure with ultrasound or other imaging modalities
including MRI or CT scan

- No definitive clinical or radiologic evidence of metastatic disease outside of the
pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan,
MRI); Negative prostate-specific membrane antigen (PSMA) positron emission
tomography (PET) is an acceptable substitute

- Age >= 18

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

- No prior radiotherapy to the region of the study cancer that would result in overlap
of radiation therapy fields

- No prior radical prostatectomy

- Prior pharmacologic androgen ablation for prostate cancer is allowed only if the
onset of androgen ablation (both luteinizing hormone releasing hormone [LHRH]
agonist and oral anti-androgen) is =< 185 days prior to registration; Please note:
PSA prior to the start of any ADT will be used to define disease

- Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation
therapy treatment planning and start of radiation therapy

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Arm I (SBRT)	Patients undergo SBRT for a total of 5 treatments over 2 weeks. Patients also undergo CT and/or MRI on study.	Procedure: Computed Tomography Undergo CT Other names: CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan tomography Procedure: Magnetic Resonance Imaging Undergo MRI Other names: Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI Other: Quality-of-Life Assessment Ancillary studies Other names: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Radiation: Stereotactic Body Radiation Therapy Undergo SBRT Other names: SABR SBRT Stereotactic Ablative Body Radiation Therapy
Active Comparator Arm II (EBRT)	Patients undergo EBRT for 20 to 45 treatments over 4 to 9 weeks. Patients also undergo CT and/or MRI on study.	Procedure: Computed Tomography Undergo CT Other names: CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan tomography Radiation: External Beam Radiation Therapy Undergo EBRT Other names: Definitive Radiation Therapy EBRT External Beam Radiation External Beam Radiotherapy External Beam Radiotherapy (conventional) External Beam RT external radiation External Radiation Therapy external-beam radiation Radiation, External Beam Teleradiotherapy Teletherapy Teletherapy Radiation Procedure: Magnetic Resonance Imaging Undergo MRI Other names: Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI Other: Quality-of-Life Assessment Ancillary studies Other names: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies

Recruiting Locations

University of Alabama at Birmingham Cancer Center
Birmingham 4049979, Alabama 4829764 35233

Contact:
Site Public Contact
205-934-0220
tmyrick@uab.edu

The Kirklin Clinic at Acton Road
Birmingham 4049979, Alabama 4829764 35243

Contact:
Site Public Contact
205-934-0220
tmyrick@uab.edu

Lewis and Faye Manderson Cancer Center
Tuscaloosa 4094455, Alabama 4829764 35401

Contact:
Site Public Contact
800-338-2948

University of Arkansas for Medical Sciences
Little Rock 4119403, Arkansas 4099753 72205

Contact:
Site Public Contact
501-686-8274

Kaiser Permanente-Deer Valley Medical Center
Antioch 5324200, California 5332921 94531