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Completed

NCT Number: NCT00831623

Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer

The purpose of this study is to determine hypofractionated conformal proton beam radiation therapy of prostate cancer can achieve similar treatment benefits as our current institutional standard with conventional fractionation.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Medical Center / James M. Slater Proton Treatment Center

Loma Linda, California, 92354, United States

About this study

Radiation therapy has a long and established role in the curative treatment of organ-confined prostate cancer. However, the optimal radiation dose and treatment schedule remain unknown. The use of hypofractionation has a long and generally successful history in conformal proton beam therapy. Several reports detailing the efficacy and safety of hypofractionated conformal radiation therapy (with x-rays) of prostate cancer can be found in the literature. Hypofractionated conformal proton beam radiation therapy has become our institutional routine for the treatment of numerous solid tumors. The purpose of this study is to determine if a shortened overall treatment schedule will result in equivalent tumor control rates and no increased side effects as compared to our current institutional standard treatment of an equivalent dose given over a longer period of time.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed adenocarcinoma within 180 days of registration
  • History & Physical Exam, including digital rectal exam (DRE), within 8 wks prior to registration
  • Histologic evaluation of prostate biopsies at LLUMC, with Gleason score assignment
  • Clinical stage, Tumor Stage (T1-T2C)
  • Prostatic Specific Antigen (PSA) less than 10 ng.ml within 180 days prior to registration

Exclusion criteria

  • Prior or concurrent invasive malignancy
  • Evidence of distant metastasis

Treatment and study plan

Proton Radiation

Radiation

3 Cobalt Gray Equivalent (CGE) /Day to isocenter, one treatment per day, 5 days per week for 20 treatments (=60 CGE to isocenter/20 fractions)

Proton

Radiation

As above

Other names: Proton Radiation treatment

Primary outcomes

  1. Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0

    Time frame: Every 6 months after completing treatment through the duration of the trial with a minimum of 2 years follow-up and an average of 5 years

    To determine if late CTCAE version 4.0 Grade 3 treatment-related morbidity, which is no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule.

Secondary outcomes

  1. Number of Participants With Acute and Late Gastrointestinal or Genitourinary Grade 2 Morbidity, CTCAE Version 4.0

    Time frame: Every 6 months after completing treatment through the duration of the trial, with a minimum of 2 years follow-up and an average of 5 years

    To determine if late CTCAE version 4.0 Grade 2 treatment-related morbidity, which is no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

Phase I-II Trial of Hypofractionated Conformal Proton Beam Radiation Therapy for Favorable-risk Prostate Cancer

Important dates

Study start
2009
Primary completion
2019
Study completion
2019
First posted
Jan 29, 2009
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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