Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer (PR07)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
First received: June 1, 2011
Last updated: March 7, 2016
Last verified: March 2016
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.

Condition Intervention Phase
Prostate Cancer
Radiation: 70 Gy/CGE
Radiation: 72.5 Gy/CGE
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Expanded Phase II Study of Hypofractionated Dose Intense 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:
  • Cumulative incidence of treatment-related grade 2 or higher rectal bleeding. [ Time Frame: 2 years after completion of radiation therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Analyzation of quality of life [ Time Frame: After radiation: every 6 months for 3 years, then annually for 20 years ] [ Designated as safety issue: No ]
  • Analysis of treatment-related morbidity [ Time Frame: Cumulative incidence up to 20 years after completion of radiation therapy ] [ Designated as safety issue: Yes ]
  • Analysis of disease control [ Time Frame: Cumulative incidence up to 20 years after completion of radiation therapy ] [ Designated as safety issue: Yes ]
    Proportion of patients with disease control after completion of treatment

  • Analysis of overall survival [ Time Frame: Cumulative incidence up to 20 years after completion of radiation therapy ] [ Designated as safety issue: Yes ]
    Proportion of patients alive after completion of treatment

Estimated Enrollment: 360
Study Start Date: September 2011
Estimated Study Completion Date: September 2036
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Risk
70 Gy/CGE
Radiation: 70 Gy/CGE
Low Risk
Experimental: Intermediate Risk
72.5 Gy/CGE
Radiation: 72.5 Gy/CGE
Intermediate Risk


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01368055

United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32209
Sponsors and Collaborators
University of Florida
Principal Investigator: Randal H. Henderson, MD, MBA University of Florida Proton Therapy Institute
  More Information

Additional Information:
American Cancer Society. 2010. Ref Type: Electronic Citation
Common Terminology Criteria for Adverse Events (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.
McGowan, D, Hunt, D, Jones, C, et al. Effect of short-term endocrine therapy prior to and during radiation therapy on overall survival in patients with T1b-T2b adenocarcinoma of the prostate and PSA equal to or less than 20: Initial results of RTOG 94-08 (abstract). American Society of Clinical Oncology (ASCO) 2010 Genitourinary Cancers Symposium. (Abstract available online: http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_meeting_categories_view&confID=73, accessed on March 19, 2010).

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01368055     History of Changes
Other Study ID Numbers: UFPTI 1103-PR07 
Study First Received: June 1, 2011
Last Updated: March 7, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Proton Radiation, Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on May 25, 2016