Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer

NCT01368055 | Completed DMC

• 2 other identifiers: UFPTI 1103-PR07IRB201701768
• Study Type: interventional
• Target: 361
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to give a shorter course (5 ½-6 weeks) of proton radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of proton radiation, without decreasing the chance of killing prostate cancer cells.

Conditions

Prostate Cancer

Keywords

Proton Radiation, Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of treatment-related grade 2 or higher rectal bleeding.

  2 years after completion of radiation therapy

Secondary Outcomes (4)

• Analyzation of quality of life

  After radiation: every 6 months for 3 years, then annually for 20 years

• Analysis of treatment-related morbidity

  Cumulative incidence up to 20 years after completion of radiation therapy

• Analysis of disease control

  Cumulative incidence up to 20 years after completion of radiation therapy

• Analysis of overall survival

  Cumulative incidence up to 20 years after completion of radiation therapy

Study Arms (2)

Low Risk

EXPERIMENTAL

70 Gy/CGE

Radiation: 70 Gy/CGE

Intermediate Risk

EXPERIMENTAL

72.5 Gy/CGE

Radiation: 72.5 Gy/CGE

Interventions

70 Gy/CGE RADIATION

Low Risk

Low Risk

72.5 Gy/CGE RADIATION

Intermediate Risk

Intermediate Risk

Eligibility Criteria

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

You may qualify if:

• Prostate cancer.
• Gleason score 2-6 or 7.
• PSA ≤ 20 ng/ml.

You may not qualify if:

• Previous prostate cancer surgery or pelvic radiation.
• Prior/concurrent systemic chemotherapy for prostate cancer.
• Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.
• History of hip replacement.
• Prior intrapelvic surgery.
• Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its uses during radiation.
• Receiving continuous and current anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), dabigatran etexilate mesylate (Pradaxa),enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32209, United States

Location

Related Publications (50)

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Related Links

• (Contact the University of Florida Proton Therapy Institute)

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Curtis Bryant, MD, MPH

  University of Florida Proton Therapy Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 7, 2011
• Study Start: September 1, 2011
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

US (1)