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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.


Inclusion Criteria:



- Histologically confirmed adenocarcinoma within 180 days of registration

- History & Physical Exam, including DRE, within 8 wks prior to registration

- Histologic evaluation of prostate biopsies at LLUMC, with Gleason score
assignment

- Clinical stage T1-T2C

- PSA less than 10 ng.ml within 180 days prior to registration

Exclusion Criteria:

- Prior or concurrent invasive malignancy

- Evidence of distant metastasis

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine if late RTOG greater than and equal to Grade 3 treatment-related morbidity, no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule

Outcome Time Frame:

yearly update

Safety Issue:

Yes

Principal Investigator

Jerry D Slater, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Loma Linda University Medical Center Dept. of Radiation Medicine

Authority:

United States: Institutional Review Board

Study ID:

58116

NCT ID:

NCT00831623

Start Date:

March 2009

Completion Date:

June 2018

Related Keywords:

  • Prostate Cancer
  • hypofractionation
  • proton beam radiation
  • Prostatic Neoplasms

Name

Location
Loma Linda University Medical Center / James M. Slater Proton Treatment Center Loma Linda, California  92354