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Proton Beam or Intensity-Modulated Radiation Therapy in Treating Patients with Low or Low-Intermediate Risk Prostate Cancer

Trial Status: Temporarily Closed to Accrual

This phase III trial studies intensity-modulated radiation therapy (IMRT) or proton beam therapy (proton beam radiation therapy) (PBT) and how well the work in treating patients with prostate cancer. Radiation therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. It is not yet known whether IMRT or PBT is more effective in treating patients with prostate cancer.

Inclusion Criteria

  • Males diagnosed with histologically confirmed, adenocarcinoma of the prostate based on core biopsy prior to study entry from transrectal ultrasonography (TRUS)
  • American Joint Committee on Cancer (AJCC) 7th edition clinical stages T1c to T2c
  • Prostate specific antigen (PSA) < 20, within 6 months of study entry * Participants who are currently receiving dutasteride (or have received it within the last 90 days) or finasteride (or have received it within the last 30 days) must have a PSA of =< 10
  • Gleason score, obtained at biopsy, =< 6, 3 + 4 = 7, or 4 + 3 = 7
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1 as documented within 3 months prior to study entry
  • Age >= 18 years
  • Participants must have a complete history and physical examination within 45 days of study entry * Participants must have a digital rectal examination (confirming clinical stage T1c to T2c) of prostate within 180 days of study entry

Exclusion Criteria

  • Prior surgery (not including TURP), cryosurgery, radiofrequency ablation, chemotherapy or radiation for PCa
  • Prior or planned androgen deprivation or bilateral orchiectomy
  • Individuals with distant metastases or clinically or pathologically involved lymph nodes are ineligible; if suspected, they must be ruled out by computed tomography (CT), pelvic magnetic resonance imaging (MRI), or bone scan within 365 days of study entry
  • Bilateral hip prostheses, inflammatory bowel disease or connective tissue disorder such as active scleroderma or lupus (radiotherapy contraindications)
  • Individuals with a history of other malignancies are ineligible unless 1) they have been disease-free for at least 5 years OR 2) are deemed by the investigator to be at low risk for recurrence of that malignancy with no plans for adjuvant systemic chemotherapy and/or radiation therapy and have received overall principal investigator approval
  • Individuals who are known to have acquired immunodeficiency syndrome (AIDS) (cluster of differentiation [CD] 4 < 200 or an AIDS-defining illness) or are known to be human immunodeficiency virus (HIV) positive and not on highly active antiretroviral therapy (HAART) are ineligible
  • Individuals with major medical or psychiatric illness which would prevent the completion of study treatment and/or interfere with follow up are excluded from this study
  • Individuals with any of the following conditions are excluded from this study: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * History of hepatic insufficiency resulting in clinical jaundice and/or coagulation defects within the last 12 months

Florida

Jacksonville
University of Florida Proton Therapy Institute
Status: ACTIVE
Contact: Nancy Price Mendenhall
Phone: 904-588-1475
Miami
Miami Cancer Institute
Status: WITHDRAWN
Contact: Marcio Augusto Fagundes
Phone: 786-527-8044

Illinois

Geneva
Northwestern Medicine Cancer Center Delnor
Status: CLOSED_TO_ACCRUAL
Contact: William F. Hartsell
Phone: 630-821-6400
Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: CLOSED_TO_ACCRUAL
Contact: William F. Hartsell
Phone: 630-821-6400
Northwestern Medicine Chicago Proton Center
Status: ACTIVE
Contact: William F. Hartsell
Phone: 630-821-6400

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Mark V. Mishra
Phone: 410-328-6080
Bel Air
UM Upper Chesapeake Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Mark V. Mishra
Phone: 410-328-6080
Columbia
Central Maryland Radiation Oncology in Howard County
Status: CLOSED_TO_ACCRUAL
Contact: Mark V. Mishra
Phone: 410-328-6080
Elkton
University of Maryland Radiation Oncology Center at Union Hospital
Status: ACTIVE
Contact: Mark V. Mishra
Phone: 410-328-6080
Glen Burnie
UM Baltimore Washington Medical Center / Tate Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Mark V. Mishra
Phone: 410-328-6080

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Jason Alexander Efstathiou
Phone: 617-726-5866
Danvers
Mass General / North Shore Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Derek Barrett Chism
Phone: 978-882-6060
Newton
Newton-Wellesley Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Joanna Y. (Chin) Tansky

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Thomas Michael Pisansky
Phone: 507-284-2511

Missouri

Saint Louis
Washington University School of Medicine
Status: ACTIVE
Contact: Jeff M. Michalski
Phone: 314-362-8566

New Jersey

Freehold
CentraState Medical Center
Status: ACTIVE
Contact: Oren Cahlon
Phone: 212-639-5219
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE
Contact: Rahul R. Parikh
Phone: 732-253-3939
Somerset
ProCure Proton Therapy Center-Somerset
Status: CLOSED_TO_ACCRUAL
Contact: Edward M. Soffen
Phone: 609-655-5755

New York

Commack
Memorial Sloan Kettering Commack
Status: COMPLETED
Contact: Oren Cahlon
Phone: 212-639-5219
Sleepy Hollow
Memorial Sloan Kettering Sleepy Hollow
Status: COMPLETED
Contact: Oren Cahlon
Phone: 212-639-5219
Uniondale
Memorial Sloan Kettering Nassau
Status: COMPLETED
Contact: Oren Cahlon
Phone: 212-639-5219
West Harrison
Memorial Sloan Kettering Westchester
Status: COMPLETED
Contact: Oren Cahlon
Phone: 212-639-5219

Ohio

Beachwood
UHHS-Chagrin Highlands Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Gordon Z. Guo
Chardon
Geauga Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Gordon Z. Guo
Cleveland
Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Status: ACTIVE
Contact: Gordon Z. Guo
Elyria
Mercy Cancer Center-Elyria
Status: CLOSED_TO_ACCRUAL
Contact: Gordon Z. Guo
Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
Status: CLOSED_TO_ACCRUAL
Contact: Gordon Z. Guo
Westlake
UHHS-Westlake Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Gordon Z. Guo

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Justin E. Bekelman
Phone: 215-662-7266

Tennessee

Knoxville
Provision Center for Proton Therapy
Status: ACTIVE
Contact: Robert Steven Lavey
Provision Radiation Therapy
Status: CLOSED_TO_ACCRUAL
Contact: Robert Steven Lavey

Washington

Seattle
SCCA Proton Therapy Center
Status: CLOSED_TO_ACCRUAL
Contact: Jing Zeng
Phone: 206-598-4100
Seattle Cancer Care Alliance
Status: CLOSED_TO_ACCRUAL
Contact: Jing Zeng
Phone: 206-598-4100
University of Washington Medical Center - Montlake
Status: ACTIVE
Contact: Jing Zeng
Phone: 206-598-4100

PRIMARY OBJECTIVE:

I. Compare the reduction in mean Expanded Prostate Cancer Index Composite (EPIC) bowel scores for men with low or intermediate risk prostate cancer (PCa) treated with PBT versus IMRT at 24 months following radiation (where higher scores represent better outcomes).

SECONDARY OBJECTIVES:

I. Assess the effectiveness of PBT versus IMRT for men with low or intermediate risk PCa in terms of disease-specific quality of life as measured by patient-reported outcomes, perceptions of care and adverse events.

II. Assess the cost-effectiveness of PBT versus IMRT under current conditions and model future cost-effectiveness for alternative treatment delivery and cost scenarios.

III. Develop predictive models to examine the associations between selected metrics of individual radiation dose distributions (including both the planned and delivered doses estimated based on serial imaging) and patient reported bowel, urinary, and erectile function.

IV. Identify and evaluate biomarkers of prostate cancer behavior and response to radiotherapy.

V. Assess longer-term rates of disease-specific and overall survival as well as development of late effects such as second cancers.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo IMRT 5 days a week for 9 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo PBT 5 days a week for 9 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Dana-Farber Harvard Cancer Center

Principal Investigator
Jason Alexander Efstathiou

  • Primary ID 11-497
  • Secondary IDs NCI-2012-01144
  • Clinicaltrials.gov ID NCT01617161