Trial Information
Pelvic Lymph Node Irradiation With Simultaneous Integrated Boost to Prostate for High Risk Prostate Cancer Patients: A Phase I/II Study
Inclusion Criteria:
- adenocarcinoma
- T3 tumor and either Gleason 8-10 and PSA ≤ 70,or PSA ≥ 30 and PSA ≤ 70, or T1-T3 and
PSA ≤ 70 and N1
- no distant metastases
Exclusion Criteria:
- pelvic co-morbidity such as Crohns disease or ulcerative colitis
- uncontrolled heart or lung morbidity
- prior radiation treatment of pelvic region
- age > 75 years
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of late gastro-intestinal toxicity ≥ grade 2.
Outcome Description:
based on CTCAE v.4.0 og in-house questionnaire.
Outcome Time Frame:
3 years and beyond
Safety Issue:
Yes
Principal Investigator
Lise N Bentzen, MD., Ph.D
Investigator Role:
Principal Investigator
Investigator Affiliation:
Aarhus University Hospital, Daproca, CIRRO
Authority:
Denmark: Ethics Committee
Study ID:
CIRRO IP080210
NCT ID:
NCT01417676
Start Date:
April 2011
Completion Date:
December 2021
Related Keywords:
- Prostate Cancer
- prostate cancer
- locally advanced
- lymph node positive
- radiation therapy
- morbidity
- early morbidity
- late morbidity
- Prostatic Neoplasms