A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate
Condition: Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT01230866
Sponsor: Proton Collaborative Group
Phase: Phase 3
- Age: minimum 18 Years maximum N/A
- Gender: Male
- Histologically confirmed prostate adenocarcinoma within 365 days prior to randomization.
- 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 recommended.
- 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 randomization.
- 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.
- Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.
- 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 colitis.
- 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).
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