Prostate Cancer Clinical Trial
Proton Radiation Therapy in Treating Patients With Prostate Cancer
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This clinical trial is studying how well proton radiation therapy works in treating patients with prostate cancer.
I. Feasibility of proton radiation therapy (RT) using standard fractionation.
I. To determine freedom from failure (FFF) (vs. biochemical/clinical progression-free survival) with standard fractionation.
II. To determine the incidence of grade 2 or greater GU and GI toxicity with this regimen at 6 months, 2 years and 3 years.
III. To assess quality of life issues following completion of radiation therapy at 6 months and at 2 years.
IV. To assess incidence of impotence after the use of proton therapy at 3 years.
V. To determine freedom from biochemical failure (BF) at 5 years.
VI. To determine clinical failure: local and/or distant at 5 years. VII. To determine salvage androgen deprivation (SAD) use at 5 years. VIII. To determine progression free survival: using clinical, biochemical and SAD as events at 5 years.
IX. To determine overall survival at 5 years. X. To determine disease-specific survival at 5 years.
XI. Estimate prostate and normal structures movement during RT with the use of scans.
XII. Correlate pathologic and radiologic findings with outcomes at 5 years. XIII. Correlate PSA and free PSA levels with outcomes at 5 years. XIV. Correlate testosterone levels and variation with proton therapy and outcomes at 5 years.
XV. Develop a quality assurance process for proton prostate therapy.
Patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3 months, every 6 months for 5 years, and then annually thereafter.
Histologically confirmed prostate adenocarcinoma within 365 days of registration
Clinical stages T1a-T2a N0 M0
For any pelvic lymph node >= 1.5cm, biopsy of the lymph node is mandatory
Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-6; > 6 cores is strongly recommended; the highest Gleason score in any core reported on the pathology report will be used for determining inclusion
PSA values < 10 ng/ml within 90 days prior to registration, done either prior to prostate biopsy or at least 21 days after prostate biopsy.
Alkaline phosphatase within 60 days prior to registration. If alkaline phosphatase is elevated > 2 x the upper limit of institutional normal (UNL), patient must have radiological correlation to assess for metastases
Zubrod status 0-1 documented within 60 days of registration
Prior androgen deprivation is allowed; however, androgen deprivation will not be continued concurrently or as an adjuvant therapy
Patients must give IRB-approved study-specific informed consent
Patients must complete all required tests listed within the specified time frames
Patients must be able to start treatment within 56 days of registration
Members of all races and ethnic groups are eligible for this trial
Clinical stages T2c or greater
PSA of 10 ng/ml or greater
Gleason score 7 or higher
Evidence of distant metastasis
Evidence of lymph node involvement
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, or ulcerative colitis are not allowed
Prior systemic chemotherapy for prostate cancer
History of proximal urethral stricture requiring dilatation
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There is 1 Location for this study
Philadelphia Pennsylvania, 19104, United States
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