UAMS - Translational Research Institute

Conditions

• Stage III Prostate Cancer AJCC v8
• Stage IVA Prostate Cancer AJCC v8

Eligibility

Eligible Ages

Over 18 Years

Eligible Genders

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) > 20 ng/mL prior to starting 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 computed tomography (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

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

Detailed Description

PRIMARY OBJECTIVE: I. To compare metastasis-free survival, determined using conventional imaging, between men with high-risk prostate cancer randomized to ultrahypofractionation (stereotactic body radiation therapy [SBRT]) to those randomized to moderate hypofractionation and conventional fractionation. SECONDARY OBJECTIVES: I. To compare physician-reported toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5 between treatment arms. II. To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported urinary function (assessed by Expanded Prostate Cancer Index Composite [EPIC]-26 urinary domains). III. To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported bowel function (assessed by EPIC-26 bowel domain). IV. To compare patient-reported fatigue (assessed by Patient Reported Outcomes Measurement Information System [PROMIS]-Fatigue) between treatment arms. V. To compare patient-reported treatment burden (assessed by COmprehensive Score for financial Toxicity [COST]) between treatment arms. VI. To compare failure-free survival between treatment arms. VII. To compare metastasis-free survival based on molecular imaging between treatment arms. VIII. To compare overall survival between treatment arms. EXPLORATORY OBJECTIVES: I. To compare patient-reported sexual function (assessed by EPIC-26 sexual domain) between treatment arms. II. To compare patient-reported quality of life (assessed by European Quality of Life Five Dimension Five Level Scale Questionnaire [EQ-5D-5L]) between treatment arms. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo SBRT for a total of 5 treatments over 2 weeks. ARM II: Patients undergo external beam radiation treatment (EBRT) for 20-45 treatments over 4 to 9 weeks. Patients are followed up every 6 months for 5 years.