Proton Radiation Therapy in Treating Patients With Prostate Cancer
A Phase II Trial of Proton Radiation Therapy of Using Standard Fractionation for Low-and Low-Intermediate Risk Adenocarcinoma of the Prostate
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19104
- Abramson Cancer Center of the University of Pennsylvania
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Arm I
Patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in the absence of disease progression or unacceptable toxicity.
|
Proton Beam Radiation Therapy
Quality of Life Assessment
Questionnaire Administration
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility
기간: 5 years
|
5 years
|
|
Acute toxicity as assessed by NCI CTC Version 3.0
기간: 90 days
|
90 days
|
2차 결과 측정
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Late toxicity as assessed by RTOG/EORTC late morbidity scoring system
기간: 90 days
|
90 days
|
|
Biochemical/clinical progression-free survival
기간: 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
|
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
|
공동 작업자 및 조사자
스폰서
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (예상)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .