Status:
COMPLETED
DAPROCA Pelvic Lymph Node Irradiation to Prostate for High Risk Prostate Cancer: Phase I/II Study
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Rigshospitalet, Denmark
Herlev Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
18-75 years
Phase:
NA
Brief Summary
This is a prospective, open label 1 arm study, multicentre, Phase I/II clinical safety study. The trial is designed to gain initial safety and efficacy data on pelvic lymph node radiation with simulta...
Eligibility Criteria
Inclusion
- 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
- pelvic co-morbidity such as Crohns disease or ulcerative colitis
- uncontrolled heart or lung morbidity
- prior radiation treatment of pelvic region
- age \> 75 years
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT01417676
Start Date
April 1 2011
End Date
May 1 2019
Last Update
July 1 2020
Active Locations (1)
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1
Dept. of Oncology, Aarhus University Hospital
Aarhus, Denmark, 8000