Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer

Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:November 2010
Contact:Corey Woods, RN, MS, CCRC

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A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate

The purpose of this study is to compare the effects (good and bad) on patients with prostate
cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks)
with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of
the treatments are similar or better.

Inclusion Criteria:

- Histologically confirmed prostate adenocarcinoma within 365 days prior to

- History/physical examination with digital rectal examination of the prostate and
baseline toxicity assessment within 90 days prior to randomization.

- Histological evaluation of prostate biopsy with assignment of a Gleason score to the
biopsy material;Gleason score must be in the range of 2-6. > 6 cores are strongly

- PSA values < 10 ng/ml within 90 days prior to randomization. Either done prior to
biopsy or at least 21 days after prostate biopsy.

- Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.). Staging must be done by
treating investigator.

- No pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is
biopsied and negative.

- Patients must be at least 18 years old.

- ECOG performance status 0-1 (appendix I) documented within 90 days prior to

- IPSS score <= 16.

- Patients must give IRB approved, study specific, informed consent.

- Patients must complete all mandatory tests listed in section 4.0 within the specified
time frames.

- Patients must be able to start treatment within 56 days of randomization.

Exclusion Criteria:

- Previous prostate cancer surgery to include: prostatectomy, hyperthermia and

- Previous pelvic radiation for prostate cancer.

- Androgen deprivation therapy prior to radiation is allowed. However, it is not
acceptable if continued during radiation or as adjuvant therapy.

- Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative

- Prior systemic chemotherapy for prostate cancer.

- History of proximal urethral stricture requiring dilatation.

- Current and continuing anticoagulation with warfarin sodium (Coumadin, heparin,
low-molecular weight heparin, Clopidogrel bisulfate (Plavix),or equivalent. (Unless it
can be stopped to manage treatment related toxicity, to have a biopsy if needed, or
for marker placement).

- Any major medical, addictive or psychiatric illnesses which would affect the consent
process, completion of treatment and/or interfere with follow-up. Consent by legal
authorized representative is not permitted in this study.

- Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year
survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell
cancer of the skin is allowed).
We found this trial at
Oklahoma City, Oklahoma 73142
Principal Investigator: Gary Larson, MD
Phone: 405-773-6775
Oklahoma City, OK
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Baltimore, Maryland 21201
Principal Investigator: Shahed Badiyan, MD
Phone: 410-369-5353
Baltimore, MD
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Hampton, Virginia 23666
Principal Investigator: Christopher Sinesi, MD
Phone: 757-251-6839
Hampton, VA
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Phoenix, Arizona 85054
Phone: 855-776-0015 (toll free)
Phoenix, AZ
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Warrenville, Illinois 60555
Principal Investigator: William Hartsell, MD
Phone: 630-315-1797
Warrenville, IL
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