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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01368055
Recruitment Status : Active, not recruiting
First Posted : June 7, 2011
Last Update Posted : January 19, 2018
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment
Prostate Cancer Radiation: 70 Gy/CGE Radiation: 72.5 Gy/CGE

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2011
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2036

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Cumulative incidence of treatment-related grade 2 or higher rectal bleeding. [ Time Frame: 2 years after completion of radiation therapy ]

Secondary Outcome Measures :
  1. Analyzation of quality of life [ Time Frame: After radiation: every 6 months for 3 years, then annually for 20 years ]
  2. Analysis of treatment-related morbidity [ Time Frame: Cumulative incidence up to 20 years after completion of radiation therapy ]
  3. Analysis of disease control [ Time Frame: Cumulative incidence up to 20 years after completion of radiation therapy ]
    Proportion of patients with disease control after completion of treatment

  4. Analysis of overall survival [ Time Frame: Cumulative incidence up to 20 years after completion of radiation therapy ]
    Proportion of patients alive after completion of treatment

Information from the National Library of Medicine

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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 2-6 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
IRB201701768 ( Other Identifier: University of Florida )
First Posted: June 7, 2011    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

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

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

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