A Phase II Trial of Proton Radiation Therapy of Using Standard Fractionation for Low-and Low-Intermediate Risk Adenocarcinoma of the Prostate
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
Detailed Description PRIMARY OBJECTIVES: I. Feasibility of proton radiation therapy (RT) using standard fractionation. SECONDARY OBJECTIVES: 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. OUTLINE: 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility
Time Frame: 5 years
Acute toxicity as assessed by NCI CTC Version 3.0
Time Frame: 90 days
Secondary Outcomes
- Biochemical/clinical progression-free survival(Time from start of radiotherapy to either documented increase in PSA or clinical progression of disease, death due to any cause or last patient contact alive)
- Late toxicity as assessed by RTOG/EORTC late morbidity scoring system(90 days)