A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate
- 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
- 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
- Patients must be able to start treatment within 56 days of randomization.
- 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).