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

This study is currently recruiting participants.
Verified March 2013 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01368055
First received: June 1, 2011
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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, disease control, survival outcome parameters [ Time Frame: After radiation: every 6 months for 3 years, then annually for 20 years ] [ Designated as safety issue: Yes ]

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

  Eligibility

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

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 proximal urethral stricture requiring dilatation.
  • 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368055

Contacts
Contact: Intake Coordinator 877-686-6009

Locations
United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32209
Contact: Intake Coordinator     877-686-6009        
Principal Investigator: Randal H. Henderson, MD, MBA            
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Randal H. Henderson, MD, MBA University of Florida Proton Therapy Institute
  More Information

Additional Information:
(Contact the University of Florida Proton Therapy Institute)  This link exits the ClinicalTrials.gov site

Publications:
Ghilezan MJ, Jaffray DA, Siewerdsen JH, van HM, Shetty A, Sharpe MB et al. Prostate gland motion assessed with cine-magnetic resonance imaging (cine-MRI). Int.J.Radiat.Oncol.Biol.Phys. 2005; 62:406-17.
Litzenberg D, Dawson LA, Sandler H, Sanda MG, McShan DL, Ten Haken RK et al. Daily prostate targeting using implanted radiopaque markers. Int.J. Radiat.Oncol.Biol.Phys. 2002; 52:699-703.
Litzenberg DW, Balter JM, Hadley SW, Sandler HM, Willoughby TR, Kupelian PA et al. Influence of intrafraction motion on margins for prostate radiotherapy. Int.J.Radiat.Oncol.Biol.Phys. 2006; 65:548-53.
Pollack A, Zagars GK, Starkschall G, Antolak JA, Lee JJ, Huang E et al. Prostate cancer radiation dose response: results of the MD Anderson phase III randomized trial. Int.J.Radiat.Oncol.Biol.Phys. 2002; 53:1097-105.
Slater JD, Rossi CJ, Jr., Yonemoto LT, Bush DA, Jabola BR, Levy RP et al. Proton therapy for prostate cancer: the initial Loma Linda University experience. Int.J.Radiat.Oncol.Biol.Phys. 2004; 59:348-52.
King and Freeman Stereotactic Body Radiotherapy for Low-Risk Prostate Cancer: Five-Year Outcomes. Radiation Oncology 2011. Jan 10;6 (1):3
Mendenhall NP, Li Z, Hoppe BS, Marcus RB Jr, Mendenhall WM, Nichols RC, Morris CG, Williams CR, Costa J, Henderson R. Early Outcomes from Three Prospective Trials of Image-guided Proton Therapy for Prostate Cancer. Int J Radiat Oncol Biol Phys. 2010 Nov 17. [Epub ahead of print]
Coote JH, Wylie JP, Cowan RA et al. Hypofractionated Intensity-Modulated Radiotherapy for Carcinoma of the Prostate: Analysis of Toxicty. Int. J. Radiat. Oncol. Biol. Phys. 2009;74:1121-27

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 11, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013