ISRCTN78176828
Completed
未知
Radiotherapy with scanning beam protons for locally advanced prostate cancer or localised prostate cancer with risk factors: a phase II non-randomised prospective study
niversity Hospital Essen (Universitatsklinikum Essen) (Germany)0 sites240 target enrollmentOctober 8, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Prostate cancer
- Sponsor
- niversity Hospital Essen (Universitatsklinikum Essen) (Germany)
- Enrollment
- 240
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histologically confirmed prostate cancer with one of the following combinations:
- •1\.1\. T3\-T4 or Gleason greater than or equal to 8 or prostate specific antigen (PSA) greater than 20 and less than 50 ng/ml
- •1\.2\. T1c\-T2a and Gleason 7 and PSA greater than 10 and less than or equal to 20 ng/ml
- •1\.3\. T2b\-T2c and Gleason 7 or PSA greater than 10 and less than or equal to 20 ng/ml
- •2\. Performance status World Health Organization (WHO) less than or equal to 2
- •3\. No evidence of distant metastases. Minimum work\-up: a negative bone scan and an actual PSA\-value within 2 months prior to registration are required.
- •4\. Negative regional lymph nodes as established by staging lymphadenectomy. For patients denying staging lymphadenectomy, an actual computed tomography (CT) or magnetic resonance imaging (MRI) scan has to be negative for lymph node metastases.
- •5\. Men of child\-producing potential must be willing to consent to use effective contraception
- •6\. Aged greater than or equal to 18 years
- •7\. Patients must give study specific informed consent
Exclusion Criteria
- •1\. PSA greater than or equal to 50 ng/ml
- •2\. Evidence of distant metastases
- •3\. Pathological proven positive lymph nodes or regional lymph nodes greater than 1\.0 cm in the smallest diameter on imaging studies
- •4\. Prior radical prostatectomy or cryosurgery for prostate cancer
- •5\. History of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
- •6\. Prior pelvic radiotherapy or brachytherapy
- •7\. Prior systemic chemotherapy for the study cancer
- •8\. Current or continuing anti\-coagulation with Coumadin or equivalent
- •9\. Transurethral resection of the prostate or urethrotomia less than 6 months before radiotherapy
- •10\. Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any cancer
Outcomes
Primary Outcomes
Not specified
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