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

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: NCT00693238
Recruitment Status : Active, not recruiting
First Posted : June 6, 2008
Results First Posted : July 24, 2013
Last Update Posted : December 3, 2021
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Radiation: Low Risk Proton Radiation Radiation: Intermediate Risk Proton Radiation Not Applicable

Detailed Description:

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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
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
Study Start Date : April 2008
Actual Primary Completion Date : June 2012
Estimated Study Completion Date : December 2033

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Disease Control [ Time Frame: 20 years after end of radiation ]

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

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
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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): NCT00693238


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00693238    
Other Study ID Numbers: UFPTI 0702-PR04
IRB201701653 ( Other Identifier: UF IRB )
UFJ 2008-022 ( Other Identifier: UF IRB Old )
First Posted: June 6, 2008    Key Record Dates
Results First Posted: July 24, 2013
Last Update Posted: December 3, 2021
Last Verified: December 2021

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