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Proton Therapy for Low and Intermediate Risk Prostate Cancer (PR04)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of Florida Identifier:
First received: June 4, 2008
Last updated: March 2, 2017
Last verified: March 2017
The purpose of this trial is to give a shorter course (5 ½ weeks) of radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of radiation, without decreasing the chance of killing prostate cancer cells.

Condition Intervention
Prostate Cancer Radiation: Low Risk Proton Radiation Radiation: Intermediate Risk Proton Radiation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Hypofractionated Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate

Resource links provided by NLM:

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate. [ Time Frame: 6 months after the end of radiation therapy ]

Secondary Outcome Measures:
  • Disease Control [ Time Frame: 20 years after end of radiation ]

Enrollment: 228
Study Start Date: April 2008
Estimated Study Completion Date: December 2033
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Risk Proton Radiation
70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
Radiation: Low Risk Proton Radiation
Experimental: Intermediate Risk Proton Radiation
72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
Radiation: Intermediate Risk Proton Radiation

Detailed Description:

Low Risk - Total of 70 Gy/CGE over 28 treatments

Intermediate Risk - Total of 72.5 Gy/CGE over 29 treatments


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria

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

Exclusion Criteria:

  • Previous prostate cancer surgery or pelvic radiation.
  • Prior or current chemotherapy for prostate cancer.
  • Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.
  • History of proximal urethral stricture requiring dilatation.
  • History of hip replacement.
  • Diabetes requiring medication.
  • Prior intrapelvic surgery.
  • Current and continuing anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).
  • On Flomax (Tamsulosin), Hytrin (Terazosin) or Cardura (Doxazosin), Uroxatral (alfuzosin HCl).
  • Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00693238

United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Principal Investigator: Randal H Henderson, MD University of Florida
  More Information

Additional Information:
American Cancer Society. 2007. Ref Type: Electronic Citation
Common Terminology Criteria for Adverse Events v3.0 (CTCAE). National Cancer Institute. 12-12-0003. 9-9-0005. Ref Type: Electronic Citation
Vargas, C, Martinez, A, and Boike, T. Long term survival benefit of a prospective dose escalation trial using high dose rate (HDR) brachytherapy boost. Int.J.Radiat.Oncol.Biol.Phys.2005. Ref Type: Abstract

Responsible Party: University of Florida Identifier: NCT00693238     History of Changes
Other Study ID Numbers: UFPTI 0702-PR04
Study First Received: June 4, 2008
Results First Received: March 14, 2013
Last Updated: March 2, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Prostate Cancer
Proton Radiation

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on August 18, 2017