Prostate Cancer
Conditions
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.
Interventions
PROCEDUREProton Beam Radiation Therapy
Proton Beam Radiation Therapy
OTHERQuality-of-Life assessment
Quality of Life Assessment
OTHERQuestionnaire Administration
Questionnaire Administration
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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 * Patients must be able to start treatment within 56 days of registration * Members of all races and ethnic groups are eligible for this trial
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 * History of proximal urethral stricture requiring dilatation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility | 5 years |
| Acute toxicity as assessed by NCI CTC Version 3.0 | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Late toxicity as assessed by RTOG/EORTC late morbidity scoring system | 90 days |
| 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 |
Countries
United States
Outcome results
None listed