Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer

NCT01617161 | Active Not Recruiting DMC

• 1 other identifier: 11-497
• Study Type: interventional
• Target: 454
• Locations: 1 country
• Sites: 13

Brief Summary

We are studying whether men being treated for prostate cancer have the same amount of side effects from either one of two different external radiation treatments: IMRT or PBT. With IMRT, a number of x-ray beams are used to shape the radiation to the prostate. PBT is another type of external radiation treatment for prostate cancer that is used in a few centers in the United States. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop. PBT is precise like IMRT, but it uses proton beams instead of x-ray beams. IMRT and PBT aim to deliver most of the radiation to the prostate cancer while sparing surrounding tissues. Both IMRT and PBT have been used in the treatment of prostate cancer and are thought to be equally effective at curing prostate cancer. However, both treatments have also been shown to cause the potential side effects of radiation, including bowel, urinary and erectile problems. It is possible that side effect rates with PBT will be lower, the same, or even higher than with IMRT, but this has not been studied well to date. Though both of these radiation therapies have been used in the past to treat prostate cancer, there has never been a study that compares the effects of these two therapies to see which one has less side effects. In this research study, we are comparing IMRT to PBT to determine which therapy best minimizes the side effects of treatment.

Conditions

Prostate Cancer

Keywords

Low Risk; Intermediate Risk

Outcome Measures

Primary Outcomes (1)

• Efficacy of PBT vs. IMRT

  Compare the reduction in mean EPIC bowel scores for men with low or low-intermediate risk PCa treated with PBT versus IMRT at 24 months following radiation (where higher scores represent better outcomes)

  2 years

Secondary Outcomes (5)

• Disease Specific Quality of Life

  2 years

• Cost Effectiveness of PBT vs. IMRT

  2 years

• Radiation Dose and Bowel, Urinary and Erectile Function

  2 years

• Identification and Evaluation Biomarkers of PCa Behavior

  2 years

• Long Term Survival

  10 years

Study Arms (2)

PBT

ACTIVE COMPARATOR

Proton Beam Therapy

Radiation: Proton Beam Therapy

IMRT

ACTIVE COMPARATOR

Intensity Modulated Radiation Therapy

Radiation: Intensity Modulated Radiation Therapy

Interventions

Proton Beam Therapy RADIATION

5 days per week up to 9 weeks

PBT

Intensity Modulated Radiation Therapy RADIATION

5 times per week up to 9 weeks

IMRT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with histologically confirmed adenocarcinoma of the prostate based on core-biopsy within 1 year of study entry from TRUS
• Clinical stages T1c to T2c
• 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 ≤6, 3 + 4 = 7, or 4 + 3 = 7
• ECOG Performance Status 0-1 as documented within 3 months prior to study entry
• Must have complete history and physical examination within 45 days of study entry and digital rectal examination of prostate within 180 days of study entry

You may not qualify if:

• Prior surgery (not including TURP), cryosurgery, radiofrequency ablation, chemotherapy or radiation for PCa
• Prior or planned androgen deprivation or bilateral orchiectomy
• Distant metastases, or clinically or pathologically involved lymph nodes confirmed by a CT scan within 365 days of study entry
• Hip prosthesis, inflammatory bowel disease or connective tissue disorder such as active scleroderma or lupus
• 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 have AIDS (CD4 \< 200 or an AIDS-defining illness) or are HIV positive and not on HAART therapy are ineligible.
• Major medical or psychiatric illness
• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Northwestern Medicine Chicago Proton Center: collaborator
• ProCure Proton Therapy Center: collaborator
• Washington University School of Medicine: collaborator
• University of Washington: collaborator
• Rutgers Cancer Institute of New Jersey: collaborator
• Mayo Clinic: collaborator
• University Hospitals Cleveland Medical Center: collaborator
• University of Florida Proton Therapy Institute: collaborator
• Provision Center for Proton Therapy: collaborator
• Massachusetts General Hospital: lead
• University of Pennsylvania: collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (13)

University of Florida Health Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

Northwestern Medicine Chicago Proton Center

Chicago, Illinois, 60190, United States

Location

University of Maryland Medical Center

College Park, Maryland, 20742, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mass General/North Shore Cancer Center

Danvers, Massachusetts, 01923, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Princeton ProCure Proton Therapy Center

Somerset, New Jersey, 08873, United States

Location

University Hospital of Cleveland

Cleveland, Ohio, 44106, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Provision Proton Therapy Center

Knoxville, Tennessee, 37909, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Liu Y, Patel SA, Jani AB, Gillespie TW, Patel PR, Godette KD, Hershatter BW, Shelton JW, McDonald MW. Overall Survival After Treatment of Localized Prostate Cancer With Proton Beam Therapy, External-Beam Photon Therapy, or Brachytherapy. Clin Genitourin Cancer. 2021 Jun;19(3):255-266.e7. doi: 10.1016/j.clgc.2020.08.009. Epub 2020 Aug 28.

  PMID: 32972877 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Proton Therapy; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted

Study Officials

• Jason A Efstathiou, MD, DPhil

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2012
• First Posted: June 12, 2012
• Study Start: July 25, 2012
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (13)