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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00693238
First received: June 4, 2008
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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 Phase
Prostate Cancer
Radiation: Low Risk Proton Radiation
Radiation: Intermediate Risk Proton Radiation
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: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease Control [ Time Frame: 20 years after end of radiation ] [ Designated as safety issue: Yes ]

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

  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 2-7.
  • 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 ClinicalTrials.gov identifier: NCT00693238

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

Additional Information:
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.
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
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.

Responsible Party: University of Florida
ClinicalTrials.gov 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: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Prostate Cancer
Proton Radiation

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 July 24, 2014